Trial Outcomes & Findings for Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep (NCT NCT03679884)
NCT ID: NCT03679884
Last Updated: 2022-03-02
Results Overview
The primary objective of the study was to assess the long-term safety and tolerability of 10, 25 and 50 mg daridorexant. The total no. of subjects with at least one TEAE is presented here; no statistical analysis was conducted. The full set of safety data is available in the Section "Adverse events".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
804 participants
Primary outcome timeframe
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
Results posted on
2022-03-02
Participant Flow
Ninety-four sites in 14 countries (Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, Hungary, South Korea, Poland, Spain, Sweden, Switzerland, and the US) enrolled and randomized subjects.
Subjects assigned to the daridorexant arms in Study ID-078A301 and 302 received the same dose in the ID-078A303 extension study. Subjects assigned to the placebo arm in Study ID-078A301 and 302 were re-randomized to receive either placebo or 25 mg daridorexant in a 1:1 ratio, with treatment allocation stratified by age into 2 categories (\< 65 and ≥ 65 years). Note: Subjects' demographic and baseline characteristics were collected in the respective confirmatory 12-week study (ID-078A301 or 302).
Participant milestones
| Measure |
Daridorexant 10 mg
Film-coated tablets administered orally, once daily in the evening
Daridorexant 10 mg: Daridorexant 10 mg tablets
|
Daridorexant 25 mg
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg: Daridorexant 25 mg tablets
|
Daridorexant 50 mg
Film-coated tablets administered orally, once daily in the evening
Daridorexant 50 mg: Daridorexant 50 mg tablets
|
Placebo
Film-coated tablets administered orally, once daily in the evening
Placebo: Daridorexant matching placebo tablets
|
ExPlacebo/Daridorexant 25 mg
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg: Daridorexant 25 mg tablets
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
142
|
268
|
137
|
128
|
126
|
|
Overall Study
COMPLETED
|
99
|
190
|
93
|
78
|
90
|
|
Overall Study
NOT COMPLETED
|
43
|
78
|
44
|
50
|
36
|
Reasons for withdrawal
| Measure |
Daridorexant 10 mg
Film-coated tablets administered orally, once daily in the evening
Daridorexant 10 mg: Daridorexant 10 mg tablets
|
Daridorexant 25 mg
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg: Daridorexant 25 mg tablets
|
Daridorexant 50 mg
Film-coated tablets administered orally, once daily in the evening
Daridorexant 50 mg: Daridorexant 50 mg tablets
|
Placebo
Film-coated tablets administered orally, once daily in the evening
Placebo: Daridorexant matching placebo tablets
|
ExPlacebo/Daridorexant 25 mg
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg: Daridorexant 25 mg tablets
|
|---|---|---|---|---|---|
|
Overall Study
Other
|
12
|
12
|
12
|
7
|
8
|
|
Overall Study
Lack of Efficacy
|
15
|
29
|
13
|
29
|
10
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
10
|
9
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
12
|
23
|
8
|
8
|
9
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
2
|
0
|
3
|
Baseline Characteristics
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Baseline characteristics by cohort
| Measure |
Daridorexant 10 mg
n=142 Participants
Film-coated tablets administered orally, once daily in the evening
Daridorexant 10 mg: Daridorexant 10 mg tablets
|
Daridorexant 25 mg
n=270 Participants
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg: Daridorexant 25 mg tablets
|
Daridorexant 50 mg
n=137 Participants
Film-coated tablets administered orally, once daily in the evening
Daridorexant 50 mg: Daridorexant 50 mg tablets
|
Placebo
n=128 Participants
Film-coated tablets administered orally, once daily in the evening
Placebo: Daridorexant matching placebo tablets
|
ExPlacebo/Daridorexant 25 mg
n=127 Participants
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg: Daridorexant 25 mg tablets
|
Total
n=804 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Age, Categorical
<=18 years
|
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=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
469 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
62 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
335 Participants
n=10 Participants
|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
56.5 years
STANDARD_DEVIATION 15.5 • n=21 Participants
|
57.7 years
STANDARD_DEVIATION 13.8 • n=10 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
575 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
229 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
55 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
128 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
722 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not permitted as per legislation/regulation
|
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
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
81 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
135 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
722 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
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=10 Participants
|
PRIMARY outcome
Timeframe: TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.The primary objective of the study was to assess the long-term safety and tolerability of 10, 25 and 50 mg daridorexant. The total no. of subjects with at least one TEAE is presented here; no statistical analysis was conducted. The full set of safety data is available in the Section "Adverse events".
Outcome measures
| Measure |
Daridorexant 10 mg
n=142 Participants
Film-coated tablets administered orally, once daily in the evening
Daridorexant 10 mg: Daridorexant 10 mg tablets
|
Daridorexant 25 mg
n=268 Participants
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg: Daridorexant 25 mg tablets
|
Daridorexant 50 mg
n=137 Participants
Film-coated tablets administered orally, once daily in the evening
Daridorexant 50 mg: Daridorexant 50 mg tablets
|
Placebo
n=128 Participants
Film-coated tablets administered orally, once daily in the evening
Placebo: Daridorexant matching placebo tablets
|
ExPlacebo / Daridorexant 25 mg
n=126 Participants
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg: Daridorexant 25 mg tablets
|
|---|---|---|---|---|---|
|
Total no. of Subjects With at Least One TEAE
|
53 Participants
|
103 Participants
|
55 Participants
|
45 Participants
|
48 Participants
|
Adverse Events
Daridorexant 10 mg
Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths
Daridorexant 25 mg
Serious events: 12 serious events
Other events: 15 other events
Deaths: 1 deaths
Daridorexant 50 mg
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Ex-Placebo Daridorexant 25 mg
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daridorexant 10 mg
n=142 participants at risk
Film-coated tablets administered orally, once daily in the evening
Daridorexant 10 mg: Daridorexant 10 mg tablets
|
Daridorexant 25 mg
n=268 participants at risk
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg: Daridorexant 25 mg tablets
|
Daridorexant 50 mg
n=137 participants at risk
Film-coated tablets administered orally, once daily in the evening
Daridorexant 50 mg: Daridorexant 50 mg tablets
|
Placebo
n=128 participants at risk
Film-coated tablets administered orally, once daily in the evening
Placebo: Daridorexant matching placebo tablets
|
Ex-Placebo Daridorexant 25 mg
n=126 participants at risk
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg: Daridorexant 25 mg tablets
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.79%
1/126 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
0.70%
1/142 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.73%
1/137 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
General disorders
Chest discomfort
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.79%
1/126 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
General disorders
Chest pain
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
General disorders
Influenza like illness
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.73%
1/137 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.79%
1/126 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.75%
2/268 • Number of events 2 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.73%
1/137 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.73%
1/137 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 2 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.78%
1/128 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.78%
1/128 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.73%
1/137 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.73%
1/137 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.70%
1/142 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.4%
2/142 • Number of events 2 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.73%
1/137 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.70%
1/142 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.79%
1/126 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.73%
1/137 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Psychiatric disorders
Depression
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.78%
1/128 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/268 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.78%
1/128 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/142 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.37%
1/268 • Number of events 1 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/137 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/128 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
0.00%
0/126 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
Other adverse events
| Measure |
Daridorexant 10 mg
n=142 participants at risk
Film-coated tablets administered orally, once daily in the evening
Daridorexant 10 mg: Daridorexant 10 mg tablets
|
Daridorexant 25 mg
n=268 participants at risk
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg: Daridorexant 25 mg tablets
|
Daridorexant 50 mg
n=137 participants at risk
Film-coated tablets administered orally, once daily in the evening
Daridorexant 50 mg: Daridorexant 50 mg tablets
|
Placebo
n=128 participants at risk
Film-coated tablets administered orally, once daily in the evening
Placebo: Daridorexant matching placebo tablets
|
Ex-Placebo Daridorexant 25 mg
n=126 participants at risk
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg: Daridorexant 25 mg tablets
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.9%
7/142 • Number of events 10 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
5.6%
15/268 • Number of events 16 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
8.8%
12/137 • Number of events 13 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
4.7%
6/128 • Number of events 6 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
8.7%
11/126 • Number of events 11 • All treatment-emergent SAEs and AEs are reported.
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
|
Additional Information
Clinical Trial Disclosure Desk
Idorsia Pharmaceuticals Ltd
Phone: +41 58 844 00 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any study-related publication written independently by investigators must be submitted to Idorsia for review at least 30 days prior to submission for publication or presentation at a congress. Upon review, Idorsia may provide comments, and may also request alterations and/or deletions for the sole purpose of protecting its confidential information and/or patent rights. Neither the institution nor the investigator should permit publication during such a review period.
- Publication restrictions are in place
Restriction type: OTHER