Trial Outcomes & Findings for A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease (NCT NCT02660983)
NCT ID: NCT02660983
Last Updated: 2020-01-10
Results Overview
The ADAS-Cog was a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). The ADAS-cog scores range from 0 to 70, with negative change from baseline indicating clinical improvement. LOCF=last observation carried forward.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
302 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2020-01-10
Participant Flow
Participants took part in the study at 32 investigative sites in Korea from 05 August 2013 to 21 December 2018.
A total of 425 participants were screened, of which 123 were screen failures and 302 were enrolled and randomized to receive study treatment. For Double Blind (DB) Phase both efficacy and safety data is presented while for Open Label Extension (OLE) Phase, only safety data is presented.
Participant milestones
| Measure |
Placebo in DB Phase Then Donepezil in OLE Phase
Participants received placebo matched to donepezil 5 milligram (mg) tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in Double Blind (DB) Phase was up to 24 weeks. Following completion of DB Phase, participant who had consent to continue their participation in the study entered the Open Label Extension (OLE) Phase and received donepezil 5 mg tablet, orally daily till Week 6 of OLE phase. After assessment of response, maximum dose permitted was 10 milligram per day (mg/day) up to Week 24 of OLE phase. Dose reduction to 5 mg/day was permitted upon investigator discretion.
|
Donepezil in DB Phase Then Donepezil in OLE Phase
Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks. Following completion of DB Phase, participant who had consent to continue their participation in the study entered the OLE Phase and received donepezil 5 mg tablet, orally daily till Week 6 of OLE phase. After assessment of response, maximum dose permitted was 10 mg/day up to Week 24 of OLE phase. Dose reduction to 5 mg/day was permitted upon investigator discretion.
|
|---|---|---|
|
Double-blind (DB) Phase (24 Weeks)
STARTED
|
154
|
148
|
|
Double-blind (DB) Phase (24 Weeks)
Treated/Safety Set
|
153
|
147
|
|
Double-blind (DB) Phase (24 Weeks)
COMPLETED
|
130
|
122
|
|
Double-blind (DB) Phase (24 Weeks)
NOT COMPLETED
|
24
|
26
|
|
Open Label Extension Phase (24 Weeks)
STARTED
|
86
|
75
|
|
Open Label Extension Phase (24 Weeks)
Safety Set
|
86
|
75
|
|
Open Label Extension Phase (24 Weeks)
COMPLETED
|
83
|
66
|
|
Open Label Extension Phase (24 Weeks)
NOT COMPLETED
|
3
|
9
|
Reasons for withdrawal
| Measure |
Placebo in DB Phase Then Donepezil in OLE Phase
Participants received placebo matched to donepezil 5 milligram (mg) tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in Double Blind (DB) Phase was up to 24 weeks. Following completion of DB Phase, participant who had consent to continue their participation in the study entered the Open Label Extension (OLE) Phase and received donepezil 5 mg tablet, orally daily till Week 6 of OLE phase. After assessment of response, maximum dose permitted was 10 milligram per day (mg/day) up to Week 24 of OLE phase. Dose reduction to 5 mg/day was permitted upon investigator discretion.
|
Donepezil in DB Phase Then Donepezil in OLE Phase
Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks. Following completion of DB Phase, participant who had consent to continue their participation in the study entered the OLE Phase and received donepezil 5 mg tablet, orally daily till Week 6 of OLE phase. After assessment of response, maximum dose permitted was 10 mg/day up to Week 24 of OLE phase. Dose reduction to 5 mg/day was permitted upon investigator discretion.
|
|---|---|---|
|
Double-blind (DB) Phase (24 Weeks)
Protocol Violation
|
1
|
5
|
|
Double-blind (DB) Phase (24 Weeks)
Withdrawal by Subject
|
15
|
12
|
|
Double-blind (DB) Phase (24 Weeks)
Adverse Event
|
8
|
9
|
|
Open Label Extension Phase (24 Weeks)
Protocol Violation
|
1
|
1
|
|
Open Label Extension Phase (24 Weeks)
Withdrawal by Subject
|
1
|
4
|
|
Open Label Extension Phase (24 Weeks)
Adverse Event
|
1
|
3
|
|
Open Label Extension Phase (24 Weeks)
Other
|
0
|
1
|
Baseline Characteristics
A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease
Baseline characteristics by cohort
| Measure |
Double Blind (DB) Phase: Placebo
n=146 Participants
Participants received placebo matched to donepezil 5 mg tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
Double Blind (DB) Phase: Donepezil
n=137 Participants
Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
Total
n=283 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.96 years
STANDARD_DEVIATION 7.94 • n=5 Participants
|
72.31 years
STANDARD_DEVIATION 7.06 • n=7 Participants
|
72.64 years
STANDARD_DEVIATION 7.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Korean
|
146 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
283 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The FAS, LOCF, included all randomized participants who received at least one dose of study drug and had at least one postdose primary efficacy measurement. Overall number of participants analyzed included participants who were evaluable at a particular time point for this outcome measure.
The ADAS-Cog was a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). The ADAS-cog scores range from 0 to 70, with negative change from baseline indicating clinical improvement. LOCF=last observation carried forward.
Outcome measures
| Measure |
Double Blind (DB) Phase: Placebo
n=144 Participants
Participants received placebo matched to donepezil 5 mg tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
Double Blind (DB) Phase: Donepezil
n=133 Participants
Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
|---|---|---|
|
Double Blind (DB) Phase: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score (LOCF) at Week 24
|
-2.06 score on a scale
Standard Error 0.42
|
-2.64 score on a scale
Standard Error 0.44
|
PRIMARY outcome
Timeframe: Week 24Population: The FAS, LOCF, included all randomized participants who received at least one dose of study drug and had at least one postdose primary efficacy measurement. Overall number of participants analyzed included participants who were evaluable at a particular time point for this outcome measure.
The CIBIC-plus rates change in global functioning relative to baseline on a scale. The score ranges from 1 (Marked improvement) to 7 (Marked worsening). A score of "4" represents no change from baseline. LOCF=last observation carried forward.
Outcome measures
| Measure |
Double Blind (DB) Phase: Placebo
n=146 Participants
Participants received placebo matched to donepezil 5 mg tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
Double Blind (DB) Phase: Donepezil
n=135 Participants
Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
|---|---|---|
|
Double Blind (DB) Phase: Clinicians Interview-based Impression of Change-plus Caregiver Input (CIBIC-plus) Score (LOCF)
|
3.85 score on a scale
Standard Error 0.07
|
3.73 score on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The FAS, LOCF, included all randomized participants who received at least one dose of study drug and had at least one postdose primary efficacy measurement. Overall number of participants analyzed included participants who were evaluable at a particular time point for this outcome measure.
MMSE is a well-known, gold standard test for measuring the cognitive state of dementia participants. It includes items evaluating orientation to time and place, recall of objects, attention, language, and conversational abilities. The total score ranges from 0 (most impaired) to 30 (no impairment). The lower score means severe cognitive deficit. A positive change score indicated improvement from baseline. LOCF=last observation carried forward.
Outcome measures
| Measure |
Double Blind (DB) Phase: Placebo
n=146 Participants
Participants received placebo matched to donepezil 5 mg tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
Double Blind (DB) Phase: Donepezil
n=136 Participants
Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
|---|---|---|
|
Double Blind (DB) Phase: Change From Baseline in Mini-mental State Examination (MMSE) Score (LOCF) at Week 24
|
0.59 score on a scale
Standard Error 0.22
|
1.23 score on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The FAS, LOCF, included all randomized participants who received at least one dose of study drug and had at least one postdose primary efficacy measurement. Number analyzed signifies participants who were evaluable at a particular part of study for this outcome measure.
The trail making test (TMT) was an evaluation tool used to assess the cognitive function, especially for executive function. The K-TMT-e has two parts that are referred to as part A (component: serial numbers) and part B (component: serial numbers and days). The K-TMT-e was a timed test and the goal was to complete the tests accurately and as quickly as possible. Higher scores reveal greater impairment. K-TMT-e Score was measured as time taken by participants to complete goal. LOCF=last observation carried forward.
Outcome measures
| Measure |
Double Blind (DB) Phase: Placebo
n=146 Participants
Participants received placebo matched to donepezil 5 mg tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
Double Blind (DB) Phase: Donepezil
n=137 Participants
Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
|---|---|---|
|
Double Blind (DB) Phase: Change From Baseline in Executive Function Test (Korean Trail Making Test Elderly [K-TMT-e]) Score (LOCF) at Week 24
Part A
|
-5.10 seconds
Standard Error 4.38
|
-12.82 seconds
Standard Error 4.52
|
|
Double Blind (DB) Phase: Change From Baseline in Executive Function Test (Korean Trail Making Test Elderly [K-TMT-e]) Score (LOCF) at Week 24
Part B
|
1.16 seconds
Standard Error 5.41
|
-13.73 seconds
Standard Error 5.52
|
Adverse Events
Double Blind (DB) Phase: Placebo
Serious events: 24 serious events
Other events: 73 other events
Deaths: 1 deaths
Double Blind (DB) Phase: Donepezil
Serious events: 18 serious events
Other events: 86 other events
Deaths: 1 deaths
Open Label Extension (OLE) Phase: Donepezil
Serious events: 12 serious events
Other events: 63 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Double Blind (DB) Phase: Placebo
n=153 participants at risk
Participants received placebo matched to donepezil 5 mg tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
Double Blind (DB) Phase: Donepezil
n=147 participants at risk
Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
Open Label Extension (OLE) Phase: Donepezil
n=161 participants at risk
Participants who completed DB phase and consented to continue their participation in the study, were enrolled in OLE phase. In OLE phase, initially all participants received donepezil 5 mg tablet, orally daily till Week 6 of OLE phase. After assessment of response, maximum dose permitted was 10 mg/day up to Week 24 of OLE phase. Dose reduction to 5 mg/day was permitted upon investigator discretion.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion 1
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Eye disorders
Cataract
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Constipation
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
General disorders
Asthenia
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Hepatobiliary disorders
Cholangitis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Sepsis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Abscess neck
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Pneumonia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Pyelonephritis acute
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
International normalised ratio increased
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Headache
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Seizure
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
General disorders
Chest pain
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
General disorders
Sudden death
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Vascular disorders
Infarction
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
Other adverse events
| Measure |
Double Blind (DB) Phase: Placebo
n=153 participants at risk
Participants received placebo matched to donepezil 5 mg tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by placebo matched to donepezil 10 mg or 5 mg tablet, orally, once daily for up to Week 24 in maintenance period. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
Double Blind (DB) Phase: Donepezil
n=147 participants at risk
Participants received donepezil 5 mg, tablet, orally, once daily in the evening for up to Week 4 in titration period, followed by donepezil 10 mg, tablet, orally, once daily for up to Week 24 in maintenance period. Dose reduction to 5 mg/day was permitted only when 10 mg/day was intolerable due to an occurrence of adverse events of which the causal relationship with the donepezil was not ruled out. Total duration of titration and maintenance period in DB Phase was up to 24 weeks.
|
Open Label Extension (OLE) Phase: Donepezil
n=161 participants at risk
Participants who completed DB phase and consented to continue their participation in the study, were enrolled in OLE phase. In OLE phase, initially all participants received donepezil 5 mg tablet, orally daily till Week 6 of OLE phase. After assessment of response, maximum dose permitted was 10 mg/day up to Week 24 of OLE phase. Dose reduction to 5 mg/day was permitted upon investigator discretion.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Cardiac disorders
Palpitations
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Eye disorders
Glaucoma
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Eye disorders
Pterygium
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Eye disorders
Vision blurred
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Eye disorders
Cataract
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
3/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
6.8%
10/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
3.1%
5/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
4/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
3.4%
5/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Vomiting
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
4.1%
6/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
2.7%
4/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.2%
2/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
2.7%
4/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Constipation
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
2.0%
3/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.2%
2/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
2.0%
3/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.4%
2/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.4%
2/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.2%
2/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Toothache
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
General disorders
Asthenia
|
2.0%
3/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.4%
2/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.2%
2/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
General disorders
Pyrexia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
General disorders
Oedema
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
General disorders
Oedema peripheral
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
General disorders
Chest pain
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
General disorders
Fatigue
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
9/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
4.1%
6/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
2.5%
4/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Urinary tract infection
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
2.0%
3/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.4%
2/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Periodontitis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Bronchitis
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Skin infection
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Cystitis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Pharyngitis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Pneumonia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Tinea pedis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.4%
2/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Scar
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
3/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
Blood triglycerides increased
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
Weight decreased
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.2%
2/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
Blood pressure increased
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
Blood pressure decreased
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
Blood urea increased
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
Hepatic enzyme increased
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.3%
5/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
7.5%
11/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
2.5%
4/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.6%
4/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
2.0%
3/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.4%
2/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
3/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Headache
|
4.6%
7/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
6.1%
9/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
3.1%
5/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Dizziness
|
3.9%
6/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
3.4%
5/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.9%
3/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Paraesthesia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.2%
2/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Poor quality sleep
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Tremor
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.2%
2/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Syncope
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Psychiatric disorders
Insomnia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
4.8%
7/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Psychiatric disorders
Conduct disorder
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.4%
2/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Psychiatric disorders
Sleep disorder
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.2%
2/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Psychiatric disorders
Depression
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.2%
2/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Psychiatric disorders
Depressed mood
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Psychiatric disorders
Hallucination
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Haematuria
|
2.0%
3/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Dysuria
|
1.3%
2/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.4%
2/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Incontinence
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.2%
2/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Bladder dysfunction
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Renal cyst
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Reproductive system and breast disorders
Genital discomfort
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
5/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.2%
2/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.4%
2/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.4%
2/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.4%
2/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Acanthosis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Vascular disorders
Hypertension
|
2.6%
4/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.68%
1/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Vascular disorders
Hypotension
|
0.65%
1/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
1.2%
2/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
General disorders
Tenderness
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
General disorders
Chest discomfort
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
General disorders
Face oedema
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Eye disorders
Trichiasis
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Eye disorders
Astigmatism
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/153 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.00%
0/147 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
0.62%
1/161 • From the first dose of study drug to 30 days after the last dose of study drug (up to 52 weeks [DB Phase: From the first dose of study drug till Week 24; OLE Phase: Post Week 24 till Week 52])
Safety analysis set: all participants who signed informed consent received at least 1 dose of study drug and had at least 1 post-dose safety assessment. If adverse event was non-serious adverse event in DB Phase but became serious adverse event during OLE Phase, the adverse event was also analyzed as serious adverse event in OLE Phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place