Trial Outcomes & Findings for Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder (NCT NCT02841709)
NCT ID: NCT02841709
Last Updated: 2020-04-24
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
58 participants
Primary outcome timeframe
Baseline to Day 1 and Day 2 of each treatment period
Results posted on
2020-04-24
Participant Flow
Conducted at 10 centers in 2 countries (USA and Germany)
Screening phase: From informed consent to randomization, lasting a max. of 28 days and comprising a screening period (screening visit + at least 7 days at home) and a run-in period (2 consecutive PSG nights on SB placebo, + 5-12 days at home with no treatment). Note: More subjects were randomized (n = 58) than originally planned (n = 50).
Participant milestones
| Measure |
Sequence 1 (D4, D2, D3, D1 and P)
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
|
Sequence 2 (D2, P, D4, D3 and D1)
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D2, P, D4, D3 and D1, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
|
Sequence 3 (D3, D1, D2, P and D4)
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D3, D1, D2, P and D4, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
|
Sequence 4 (P, D4, D1, D2 and D3)
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: P, D4, D1, D2, and D3, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
|
Sequence 5 (D1, D3, P, D4 and D2)
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
|
|---|---|---|---|---|---|
|
1st Intervention
STARTED
|
12
|
11
|
12
|
12
|
11
|
|
1st Intervention
COMPLETED
|
12
|
11
|
12
|
12
|
11
|
|
1st Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 1
STARTED
|
12
|
11
|
12
|
12
|
11
|
|
Washout Period 1
COMPLETED
|
12
|
11
|
12
|
12
|
11
|
|
Washout Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
2nd Intervention
STARTED
|
12
|
11
|
12
|
12
|
11
|
|
2nd Intervention
COMPLETED
|
12
|
11
|
12
|
12
|
11
|
|
2nd Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2
STARTED
|
12
|
11
|
12
|
12
|
11
|
|
Washout Period 2
COMPLETED
|
12
|
11
|
12
|
12
|
11
|
|
Washout Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
3rd Intervention
STARTED
|
12
|
11
|
12
|
12
|
11
|
|
3rd Intervention
COMPLETED
|
12
|
11
|
12
|
12
|
11
|
|
3rd Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 3
STARTED
|
12
|
11
|
12
|
12
|
11
|
|
Washout Period 3
COMPLETED
|
12
|
11
|
12
|
12
|
11
|
|
Washout Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
4th Intervention
STARTED
|
12
|
11
|
12
|
12
|
11
|
|
4th Intervention
COMPLETED
|
12
|
11
|
12
|
12
|
11
|
|
4th Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 4
STARTED
|
12
|
11
|
12
|
12
|
11
|
|
Washout Period 4
COMPLETED
|
12
|
11
|
12
|
12
|
11
|
|
Washout Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
5th Intervention
STARTED
|
12
|
11
|
12
|
12
|
11
|
|
5th Intervention
COMPLETED
|
10
|
11
|
12
|
12
|
9
|
|
5th Intervention
NOT COMPLETED
|
2
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Sequence 1 (D4, D2, D3, D1 and P)
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
|
Sequence 2 (D2, P, D4, D3 and D1)
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D2, P, D4, D3 and D1, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
|
Sequence 3 (D3, D1, D2, P and D4)
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D3, D1, D2, P and D4, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
|
Sequence 4 (P, D4, D1, D2 and D3)
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: P, D4, D1, D2, and D3, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
|
Sequence 5 (D1, D3, P, D4 and D2)
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12-day washout.
|
|---|---|---|---|---|---|
|
5th Intervention
Adverse Event
|
2
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
Baseline characteristics by cohort
| Measure |
All Study Participants
n=58 Participants
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Insomnia Severity Index
|
20 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 1 and Day 2 of each treatment periodWASO 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=56 Participants
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
ACT-541468 10 mg
n=54 Participants
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
ACT-541468 25 mg
n=55 Participants
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
ACT-541468 50 mg
n=56 Participants
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
Placebo
n=54 Participants
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
|---|---|---|---|---|---|
|
Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2
|
-18.9 minutes
Standard Error 4.44
|
-32.0 minutes
Standard Error 4.50
|
-45.1 minutes
Standard Error 4.47
|
-61.4 minutes
Standard Error 4.44
|
-13.6 minutes
Standard Error 4.50
|
SECONDARY outcome
Timeframe: Baseline to Day 1 and Day 2 of each treatment periodLPS 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=56 Participants
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
ACT-541468 10 mg
n=54 Participants
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
ACT-541468 25 mg
n=55 Participants
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
ACT-541468 50 mg
n=56 Participants
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
Placebo
n=54 Participants
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D4, D2, D3, D1 and P, with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
|---|---|---|---|---|---|
|
Change in Mean Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2
|
-37.92 Minutes
Standard Deviation 48.76
|
-44.61 Minutes
Standard Deviation 41.28
|
-44.81 Minutes
Standard Deviation 41.56
|
-44.88 Minutes
Standard Deviation 44.22
|
-33.88 Minutes
Standard Deviation 41.74
|
Adverse Events
Single-blind Placebo (Run-in Period)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
ACT-541468 5 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
ACT-541468 10 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
ACT-541468 25 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
ACT-541468 50 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single-blind Placebo (Run-in Period)
n=58 participants at risk
Single-blind placebo was administered during the run-in period.
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
Placebo
n=54 participants at risk
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
ACT-541468 5 mg
n=56 participants at risk
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
ACT-541468 10 mg
n=54 participants at risk
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
ACT-541468 25 mg
n=55 participants at risk
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
ACT-541468 50 mg
n=56 participants at risk
Each subject participated in 5 treatment periods. On the evening of the first 2 days of each period they received one dose (D) of ACT-541468 or placebo orally in the following order: D1, D3, P, D4 and D2 with D4 = the highest dose (50 mg) and D1 the lowest dose (5 mg). Each treatment period was separated from the next one by a 5- to 12- day washout.
ACT-541468: Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
Placebo: Capsules for oral administration matching the ACT-541468 capsules
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Eye disorders
Photophobia
|
1.7%
1/58 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/55 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/55 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/55 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/55 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/55 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
General disorders
Fatigue
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
3.7%
2/54 • Number of events 2 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
7.1%
4/56 • Number of events 4 • Start of screening until the end of the safety follow-up period.
|
|
General disorders
Feeling abnormal
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
General disorders
Gait disturbance
|
1.7%
1/58 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
3.6%
2/56 • Number of events 3 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/55 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
Infections and infestations
Cystitis
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
3.6%
2/56 • Number of events 2 • Start of screening until the end of the safety follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/55 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Investigations
Blood pressure increased
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.7%
1/58 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
3.7%
2/54 • Number of events 2 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/55 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/55 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Nervous system disorders
Cerebellar ataxia
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
3.6%
2/56 • Number of events 2 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Nervous system disorders
Headache
|
3.4%
2/58 • Number of events 2 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
3.6%
2/56 • Number of events 2 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/55 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Nervous system disorders
Migraine
|
1.7%
1/58 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/55 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Nervous system disorders
Tremor
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 2 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Psychiatric disorders
Delusional disorder, unspecified type
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/58 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 2 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Vascular disorders
Hot flush
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.9%
1/54 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/55 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/58 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
1.8%
1/56 • Number of events 1 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/54 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/55 • Start of screening until the end of the safety follow-up period.
|
0.00%
0/56 • Start of screening until the end of the safety follow-up period.
|
Additional Information
Clinical Trials Disclosure Desk
Idorsia Pharmaceuticals Ltd
Phone: +41 588 441977
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place