Trial Outcomes & Findings for A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease (NCT NCT05063539)
NCT ID: NCT05063539
Last Updated: 2026-06-12
Results Overview
iADRS is a simple linear combination of scores from 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether LY3372689 slows down the cognitive and functional decline associated with early symptomatic Alzheimer's Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) adjusted for age at baseline, AChEI/Memantine use at baseline, pooled investigator. Data presented are posterior mean with 95% credible interval.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
327 participants
Primary outcome timeframe
Baseline, Week 100
Results posted on
2026-06-12
Participant Flow
The study consists of a double-blind treatment period with a 124-week (wk) duration followed by a post treatment follow-up (PTFU) period for 4 weeks after last blinded treatment dose and Post treatment observational extension (PTOE) period for approximately 9 months on average since last blinded treatment dose.
Participant milestones
| Measure |
0.75 Milligram (mg) LY3372689
Double-blind treatment period: Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
Post treatment follow up period: Participants who received 0.75 mg LY3372689 during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring.
Post treatment observational extension period: Participants who received 0.75 mg LY3372689 during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.
|
3 mg LY3372689
Double-blind treatment period: Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
Post treatment follow up period: Participants who received 3 mg LY3372689 during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring.
Post treatment observational extension period: Participants who received 3 mg LY3372689 during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.
|
Placebo
Double-blind treatment period: Participants received placebo administered orally once daily for up to 124 weeks.
Post treatment follow up period: Participants who received placebo during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring.
Post treatment observational extension period: Participants who received placebo during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.
|
|---|---|---|---|
|
Double-Blind Treatment Period
STARTED
|
110
|
109
|
108
|
|
Double-Blind Treatment Period
Received at Least 1 Dose of Study Drug (Safety Population)
|
108
|
110
|
108
|
|
Double-Blind Treatment Period
COMPLETED
|
86
|
70
|
89
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
24
|
39
|
19
|
|
Post-Treatment Follow-Up Period
STARTED
|
83
|
71
|
88
|
|
Post-Treatment Follow-Up Period
COMPLETED
|
80
|
64
|
83
|
|
Post-Treatment Follow-Up Period
NOT COMPLETED
|
3
|
7
|
5
|
|
Post-Treatment Observational Extension
STARTED
|
42
|
38
|
42
|
|
Post-Treatment Observational Extension
COMPLETED
|
40
|
32
|
40
|
|
Post-Treatment Observational Extension
NOT COMPLETED
|
2
|
6
|
2
|
Reasons for withdrawal
| Measure |
0.75 Milligram (mg) LY3372689
Double-blind treatment period: Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
Post treatment follow up period: Participants who received 0.75 mg LY3372689 during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring.
Post treatment observational extension period: Participants who received 0.75 mg LY3372689 during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.
|
3 mg LY3372689
Double-blind treatment period: Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
Post treatment follow up period: Participants who received 3 mg LY3372689 during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring.
Post treatment observational extension period: Participants who received 3 mg LY3372689 during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.
|
Placebo
Double-blind treatment period: Participants received placebo administered orally once daily for up to 124 weeks.
Post treatment follow up period: Participants who received placebo during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring.
Post treatment observational extension period: Participants who received placebo during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.
|
|---|---|---|---|
|
Double-Blind Treatment Period
Adverse Event
|
1
|
2
|
1
|
|
Double-Blind Treatment Period
Death
|
0
|
1
|
1
|
|
Double-Blind Treatment Period
Lost to Follow-up
|
0
|
1
|
0
|
|
Double-Blind Treatment Period
Physician Decision
|
4
|
3
|
1
|
|
Double-Blind Treatment Period
Progressive Disease
|
0
|
2
|
0
|
|
Double-Blind Treatment Period
Withdrawal by Subject
|
17
|
26
|
14
|
|
Double-Blind Treatment Period
Withdrawal Due To Caregiver Circumstances
|
1
|
1
|
0
|
|
Double-Blind Treatment Period
Participant randomized via Interactive Web Response System before Vital signs met Exclusion Criteria
|
1
|
0
|
0
|
|
Double-Blind Treatment Period
Participant no longer Wished to Continue with Investigational Product (IP) or Follow-up Visits
|
0
|
0
|
1
|
|
Double-Blind Treatment Period
Discontinued due to Common Close Design
|
0
|
1
|
0
|
|
Double-Blind Treatment Period
Participant not co-operative
|
0
|
1
|
0
|
|
Double-Blind Treatment Period
Participant Moving to Different Place from Where it takes 4 hours to Come to Site to Continue
|
0
|
0
|
1
|
|
Double-Blind Treatment Period
Caregiver Withdrew Consent due to Participant Moved to Long Term Care Home
|
0
|
1
|
0
|
|
Post-Treatment Follow-Up Period
Death
|
1
|
1
|
1
|
|
Post-Treatment Follow-Up Period
Subject Moved Out of State
|
1
|
0
|
0
|
|
Post-Treatment Follow-Up Period
Withdrawal by Subject
|
1
|
3
|
1
|
|
Post-Treatment Follow-Up Period
Adverse Event
|
0
|
1
|
0
|
|
Post-Treatment Follow-Up Period
Physician Decision
|
0
|
1
|
1
|
|
Post-Treatment Follow-Up Period
Lost to Follow-up
|
0
|
0
|
1
|
|
Post-Treatment Follow-Up Period
Progressive Disease
|
0
|
0
|
1
|
|
Post-Treatment Follow-Up Period
Subject Discontinued study
|
0
|
1
|
0
|
|
Post-Treatment Observational Extension
Death
|
0
|
1
|
0
|
|
Post-Treatment Observational Extension
Withdrawal by Subject
|
2
|
5
|
2
|
Baseline Characteristics
A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
0.75 mg LY3372689
n=110 Participants
Double-blind treatment period: Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
3 mg LY3372689
n=109 Participants
Double-blind treatment period: Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=108 Participants
Double-blind treatment period: Participants received placebo administered orally once daily for up to 124 weeks.
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.3 years
STANDARD_DEVIATION 5.40 • n=9 Participants
|
73.4 years
STANDARD_DEVIATION 5.38 • n=27 Participants
|
73.4 years
STANDARD_DEVIATION 5.47 • n=267 Participants
|
73.4 years
STANDARD_DEVIATION 5.40 • n=265 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=9 Participants
|
63 Participants
n=27 Participants
|
68 Participants
n=267 Participants
|
201 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=9 Participants
|
46 Participants
n=27 Participants
|
40 Participants
n=267 Participants
|
126 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=9 Participants
|
102 Participants
n=27 Participants
|
102 Participants
n=267 Participants
|
308 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
37 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
7 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=9 Participants
|
94 Participants
n=27 Participants
|
94 Participants
n=267 Participants
|
283 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Region of Enrollment
Australia
|
14 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
32 Participants
n=265 Participants
|
|
Region of Enrollment
Canada
|
12 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
34 Participants
n=265 Participants
|
|
Region of Enrollment
Japan
|
11 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
35 Participants
n=265 Participants
|
|
Region of Enrollment
Poland
|
16 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
55 Participants
n=265 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=9 Participants
|
55 Participants
n=27 Participants
|
59 Participants
n=267 Participants
|
171 Participants
n=265 Participants
|
|
Baseline Integrated Alzheimer's Disease Rating Scale (iADRS) Score
|
111.8 Score on a scale
STANDARD_DEVIATION 11.99 • n=9 Participants
|
109.3 Score on a scale
STANDARD_DEVIATION 13.25 • n=27 Participants
|
110.4 Score on a scale
STANDARD_DEVIATION 12.77 • n=267 Participants
|
110.5 Score on a scale
STANDARD_DEVIATION 12.68 • n=265 Participants
|
|
Screening Tau Category
Intermediate (Low-medium)
|
87 Participants
n=9 Participants
|
86 Participants
n=27 Participants
|
86 Participants
n=267 Participants
|
259 Participants
n=265 Participants
|
|
Screening Tau Category
High
|
23 Participants
n=9 Participants
|
23 Participants
n=27 Participants
|
22 Participants
n=267 Participants
|
68 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 100Population: All randomized participants with baseline or post-baseline data for this outcome with baseline Intermediate Tau level.
iADRS is a simple linear combination of scores from 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether LY3372689 slows down the cognitive and functional decline associated with early symptomatic Alzheimer's Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) adjusted for age at baseline, AChEI/Memantine use at baseline, pooled investigator. Data presented are posterior mean with 95% credible interval.
Outcome measures
| Measure |
3 mg LY3372689
n=85 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=84 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=86 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)
|
NA score on a scale
The posterior mean = -13.27, 95% credible interval (-15.481 to -11.097)
|
NA score on a scale
The posterior mean = -10.07, 95% credible interval (-11.900 to -8.338)
|
NA score on a scale
The posterior mean = -8.39, 95% credible interval (-10.219 to -6.640)
|
SECONDARY outcome
Timeframe: Baseline, Week 100Population: All randomized participants with baseline or post-baseline data for this outcome.
iADRS is a simple linear combination of scores from 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether LY3372689 slows down the cognitive and functional decline associated with early symptomatic Alzheimer's Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) adjusted for age at baseline, baseline tau PET category, AChEI/Memantine use at baseline, pooled investigator. Data presented are posterior mean with 95% credible interval.
Outcome measures
| Measure |
3 mg LY3372689
n=108 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=106 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=109 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point in iADRS (Overall Population)
|
NA score on a scale
The posterior mean = -17.14, 95% credible interval (-19.379 to -14.900)
|
NA score on a scale
The posterior mean = -12.07, 95% credible interval (-13.916 to -10.370)
|
NA score on a scale
The posterior mean = -10.48, 95% credible interval (-12.247 to -8.739)
|
SECONDARY outcome
Timeframe: Baseline, Week 76Population: All randomized participants with baseline or post-baseline data for this outcome with baseline Intermediate Tau level.
CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score are assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, AChEI/Memantine use at baseline.
Outcome measures
| Measure |
3 mg LY3372689
n=80 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=84 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=84 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population)
|
2.14 score on a scale
Standard Error 0.24
|
1.05 score on a scale
Standard Error 0.22
|
0.91 score on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline, Week 76Population: All randomized participants with baseline or post-baseline data for this outcome.
CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, baseline tau PET category, AChEI/Memantine use at baseline.
Outcome measures
| Measure |
3 mg LY3372689
n=101 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=106 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=106 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Overall Population)
|
2.81 score on a scale
Standard Error 0.27
|
1.48 score on a scale
Standard Error 0.25
|
1.54 score on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Baseline, Week 76Population: All randomized participants with baseline or post-baseline data for this outcome with baseline Intermediate Tau level.
The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviours characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, AChEI/Memantine use at baseline.
Outcome measures
| Measure |
3 mg LY3372689
n=80 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=84 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=84 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population)
|
4.91 score on a scale
Standard Error 0.76
|
5.14 score on a scale
Standard Error 0.69
|
4.00 score on a scale
Standard Error 0.70
|
SECONDARY outcome
Timeframe: Baseline, Week 76Population: All randomized participants with baseline or post-baseline data for this outcome.
The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviours characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, baseline tau PET category, AChEI/Memantine use at baseline.
Outcome measures
| Measure |
3 mg LY3372689
n=102 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=106 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=106 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population)
|
7.61 score on a scale
Standard Error 0.83
|
5.95 score on a scale
Standard Error 0.76
|
5.58 score on a scale
Standard Error 0.78
|
SECONDARY outcome
Timeframe: Baseline, Week 76Population: All randomized participants with baseline or post-baseline data for this outcome with baseline Intermediate Tau level.
The ADCS-iADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-iADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, AChEI/Memantine use at baseline.
Outcome measures
| Measure |
3 mg LY3372689
n=79 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=82 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=83 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL) (Intermediate (Low-medium) Tau Population)
|
-5.34 score on a scale
Standard Error 0.77
|
-2.82 score on a scale
Standard Error 0.70
|
-2.65 score on a scale
Standard Error 0.72
|
SECONDARY outcome
Timeframe: Baseline, Week 76Population: All randomized participants with baseline or post-baseline data for this outcome.
The ADCS-iADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-iADL measures both basic and instrumental activities (instrumental activity items 6a, 7-23) of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, baseline tau PET category, AChEI/Memantine use at baseline.
Outcome measures
| Measure |
3 mg LY3372689
n=101 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=104 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=105 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL) (Overall Population)
|
-7.26 score on a scale
Standard Error 0.83
|
-3.24 score on a scale
Standard Error 0.77
|
-4.02 score on a scale
Standard Error 0.79
|
SECONDARY outcome
Timeframe: Baseline, Week 76Population: All randomized participants with baseline or post-baseline data for this outcome with baseline Intermediate Tau level.
MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, AChEI/Memantine use at baseline.
Outcome measures
| Measure |
3 mg LY3372689
n=80 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=84 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=84 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point in Mini Mental State Examination (MMSE) (Intermediate (Low-medium) Tau Population)
|
-2.79 score on a scale
Standard Error 0.41
|
-2.25 score on a scale
Standard Error 0.37
|
-1.65 score on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline, Week 76Population: All randomized participants with baseline or post-baseline data for this outcome.
MMSE is an instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean change from baseline was calculated using natural cubic spline with 2 degrees of freedom (NCS2) adjusted for fixed effects of NCS basis expansion terms (two terms), NCS basis expansion term-by-treatment interaction, visit (in weeks), investigator site (pooled), age at baseline, baseline tau PET category, AChEI/Memantine use at baseline.
Outcome measures
| Measure |
3 mg LY3372689
n=102 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=106 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=106 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point in Mini Mental State Examination (MMSE) (Overall Population)
|
-4.00 score on a scale
Standard Error 0.44
|
-2.70 score on a scale
Standard Error 0.40
|
-2.52 score on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline, Week 76Population: All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline PET tau data.
Flortaucipir PET imaging was used as a quantitative tau biomarker. Quantitative tau burden was formalized using Standardized Uptake Value Ratio (SUVR) from the following composite brain regions: frontal, parietal, occipital, and temporal lobes and the Alzheimer's disease (AD) neocortical signature. The AD neocortical signature region of interest refers to a weighted Alzheimer's Disease specific neocortical region derived from Multiblock Barycentric Discriminant Analysis. Cerebellar gray matter was used as a reference region to derive an SUVr. Larger SUVR reflects larger tau burden. LS Mean change from baseline was calculated using ANCOVA adjusted for baseline score, age and treatment (Type III sum of squares).
Outcome measures
| Measure |
3 mg LY3372689
n=57 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=70 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=68 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Intermediate (Low-medium) Tau Population)
Frontal
|
0.03 standardized uptake value ratio (SUVR)
Standard Error 0.009
|
0.04 standardized uptake value ratio (SUVR)
Standard Error 0.008
|
0.05 standardized uptake value ratio (SUVR)
Standard Error 0.008
|
|
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Intermediate (Low-medium) Tau Population)
Parietal
|
0.03 standardized uptake value ratio (SUVR)
Standard Error 0.010
|
0.06 standardized uptake value ratio (SUVR)
Standard Error 0.009
|
0.05 standardized uptake value ratio (SUVR)
Standard Error 0.009
|
|
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Intermediate (Low-medium) Tau Population)
Lateral occipital
|
0.05 standardized uptake value ratio (SUVR)
Standard Error 0.016
|
0.07 standardized uptake value ratio (SUVR)
Standard Error 0.015
|
0.04 standardized uptake value ratio (SUVR)
Standard Error 0.015
|
|
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Intermediate (Low-medium) Tau Population)
Lateral temporal
|
0.04 standardized uptake value ratio (SUVR)
Standard Error 0.012
|
0.07 standardized uptake value ratio (SUVR)
Standard Error 0.011
|
0.07 standardized uptake value ratio (SUVR)
Standard Error 0.011
|
|
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Intermediate (Low-medium) Tau Population)
AD neocortical signature (measured using MUBADA)
|
0.05 standardized uptake value ratio (SUVR)
Standard Error 0.012
|
0.08 standardized uptake value ratio (SUVR)
Standard Error 0.010
|
0.07 standardized uptake value ratio (SUVR)
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Baseline, Week 76Population: All randomized participants with baseline and post-baseline PET tau data.
Flortaucipir PET imaging was used as a quantitative tau biomarker. Quantitative tau burden was formalized using Standardized Uptake Value Ratio (SUVR) from the following composite brain regions: frontal, parietal, occipital, and temporal lobes and the Alzheimer's disease (AD) neocortical signature. The AD neocortical signature region of interest refers to a weighted Alzheimer's Disease specific neocortical region derived from Multiblock Barycentric Discriminant Analysis. Cerebellar gray matter was used as a reference region to derive an SUVr. Larger SUVR reflects larger tau burden. LS Mean change from baseline was calculated using ANCOVA adjusted for baseline score, baseline tau PET category, age and treatment (Type III sum of squares).
Outcome measures
| Measure |
3 mg LY3372689
n=70 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=79 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Overall Population)
Frontal
|
0.06 SUVR
Standard Error 0.011
|
0.06 SUVR
Standard Error 0.011
|
0.07 SUVR
Standard Error 0.011
|
|
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Overall Population)
Parietal
|
0.08 SUVR
Standard Error 0.013
|
0.07 SUVR
Standard Error 0.012
|
0.08 SUVR
Standard Error 0.013
|
|
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Overall Population)
Lateral occipital
|
0.09 SUVR
Standard Error 0.018
|
0.09 SUVR
Standard Error 0.017
|
0.08 SUVR
Standard Error 0.018
|
|
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Overall Population)
Lateral temporal
|
0.07 SUVR
Standard Error 0.015
|
0.08 SUVR
Standard Error 0.014
|
0.08 SUVR
Standard Error 0.015
|
|
Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Overall Population)
AD neocortical signature (measured using MUBADA)
|
0.08 SUVR
Standard Error 0.015
|
0.09 SUVR
Standard Error 0.014
|
0.09 SUVR
Standard Error 0.014
|
SECONDARY outcome
Timeframe: Baseline, Week 76Population: All randomized participants with baseline Intermediate Tau level and with baseline and at least one postbaseline vMRI data.
MRI scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in brain atrophy. Volumetric MRI (vMRI) parameters were measured in brain regions: bilateral hippocampus, bilateral whole lateral ventricles, and bilateral whole brain. The atrophy was assessed by tensor-based morphometry, which captures volume changes within the deformation map. LS Mean change from baseline was determined by mixed model repeated measures (MMRM) model with fixed effects of treatment, visit, treatment-by-visit interaction, and adjusted for baseline volume, age at baseline.
Outcome measures
| Measure |
3 mg LY3372689
n=61 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=75 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=68 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Intermediate (Low-medium) Tau Population)
Bilateral Hippocampus
|
-0.16 cubic centimeter (cm^3)
Standard Error 0.019
|
-0.28 cubic centimeter (cm^3)
Standard Error 0.016
|
-0.19 cubic centimeter (cm^3)
Standard Error 0.017
|
|
Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Intermediate (Low-medium) Tau Population)
Bilateral Whole Lateral Ventricles
|
4.25 cubic centimeter (cm^3)
Standard Error 0.458
|
5.89 cubic centimeter (cm^3)
Standard Error 0.405
|
3.52 cubic centimeter (cm^3)
Standard Error 0.425
|
|
Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Intermediate (Low-medium) Tau Population)
Bilateral Whole Brain
|
-9.56 cubic centimeter (cm^3)
Standard Error 1.345
|
-18.92 cubic centimeter (cm^3)
Standard Error 1.186
|
-10.75 cubic centimeter (cm^3)
Standard Error 1.231
|
SECONDARY outcome
Timeframe: Baseline, Week 76Population: All randomized participants with baseline and at least one postbaseline vMRI data.
MRI scans at baseline and at 76 weeks after the first treatment were used to quantitatively estimate change in brain atrophy. Volumetric MRI (vMRI) parameters were measured in brain regions: bilateral hippocampus, bilateral whole lateral ventricles, and bilateral whole brain. The atrophy was assessed by tensor-based morphometry, which captures volume changes within the deformation map. LS Mean change from baseline was determined by mixed model repeated measures (MMRM) model with fixed effects of treatment, visit, treatment-by-visit interaction, and adjusted for baseline volume, baseline tau PET category, age at baseline.
Outcome measures
| Measure |
3 mg LY3372689
n=78 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
n=94 Participants
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=82 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Overall Population)
Bilateral Hippocampus
|
-0.17 cm^3
Standard Error 0.018
|
-0.29 cm^3
Standard Error 0.017
|
-0.21 cm^3
Standard Error 0.018
|
|
Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Overall Population)
Bilateral Whole Lateral Ventricles
|
5.74 cm^3
Standard Error 0.455
|
7.16 cm^3
Standard Error 0.409
|
4.95 cm^3
Standard Error 0.444
|
|
Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Overall Population)
Bilateral Whole Brain
|
-14.62 cm^3
Standard Error 1.313
|
-22.78 cm^3
Standard Error 1.195
|
-15.61 cm^3
Standard Error 1.292
|
SECONDARY outcome
Timeframe: Week 64: Post-dosePopulation: All randomized participants who received at least one 1 of study drug and had evaluable C-trough data at the specified time points
Blood samples were measured at week 64 to assess the concentration of LY3372689 in the plasma.
Outcome measures
| Measure |
3 mg LY3372689
n=69 Participants
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.
|
Placebo
Participants received placebo administered orally once daily for up to 124 weeks.
|
0.75mg LY3372689
n=76 Participants
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Plasma Concentrations of LY3372689
|
12.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 212
|
—
|
3.95 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 163
|
Adverse Events
0.75 mg LY3372689 (Double Blind Period)
Serious events: 13 serious events
Other events: 75 other events
Deaths: 0 deaths
3 mg LY3372689 (Double Blind Period)
Serious events: 29 serious events
Other events: 72 other events
Deaths: 1 deaths
Placebo (Double Blind Period)
Serious events: 16 serious events
Other events: 81 other events
Deaths: 1 deaths
0.75mg LY3372689 (Post-treatment Follow up Period and Post Treatment Observational Extension Period)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
3 mg LY3372689 (Post-treatment Follow up Period and Post Treatment Observational Extension Period)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 2 deaths
Placebo (Post-treatment Follow up Period and Post Treatment Observational Extension Period)
Serious events: 9 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
0.75 mg LY3372689 (Double Blind Period)
n=108 participants at risk
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks during the double-blind treatment period.
|
3 mg LY3372689 (Double Blind Period)
n=110 participants at risk
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks during the double-blind treatment period.
|
Placebo (Double Blind Period)
n=108 participants at risk
Participants received placebo administered orally once daily for up to 124 weeks during the double-blind treatment period.
|
0.75mg LY3372689 (Post-treatment Follow up Period and Post Treatment Observational Extension Period)
n=83 participants at risk
Post treatment follow up period: Participants who received 0.75 mg LY3372689 during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring.
Post treatment observational extension period: Participants who received 0.75 mg LY3372689 during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.
|
3 mg LY3372689 (Post-treatment Follow up Period and Post Treatment Observational Extension Period)
n=71 participants at risk
Post treatment follow up period: Participants who received 3 mg LY3372689 during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring.
Post treatment observational extension period: Participants who received 3 mg LY3372689 during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.
|
Placebo (Post-treatment Follow up Period and Post Treatment Observational Extension Period)
n=88 participants at risk
Post treatment follow up period: Participants who received placebo during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring.
Post treatment observational extension period: Participants who received placebo during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.4%
1/71 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.4%
1/71 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
2.7%
3/110 • Number of events 3 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.4%
1/71 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
General disorders
Death
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.2%
1/83 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Dental sepsis
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastrointestinal fungal infection
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.9%
2/108 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.4%
1/71 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.8%
2/110 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.2%
1/83 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.4%
1/71 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haematological malignancy
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/40 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/35 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dementia of the alzheimer's type, with delirium
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Presyncope
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Seizure
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.4%
1/71 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.1%
1/88 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.9%
2/108 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.93%
1/108 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Orthostatic hypotension
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/108 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
0.75 mg LY3372689 (Double Blind Period)
n=108 participants at risk
Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks during the double-blind treatment period.
|
3 mg LY3372689 (Double Blind Period)
n=110 participants at risk
Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks during the double-blind treatment period.
|
Placebo (Double Blind Period)
n=108 participants at risk
Participants received placebo administered orally once daily for up to 124 weeks during the double-blind treatment period.
|
0.75mg LY3372689 (Post-treatment Follow up Period and Post Treatment Observational Extension Period)
n=83 participants at risk
Post treatment follow up period: Participants who received 0.75 mg LY3372689 during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring.
Post treatment observational extension period: Participants who received 0.75 mg LY3372689 during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.
|
3 mg LY3372689 (Post-treatment Follow up Period and Post Treatment Observational Extension Period)
n=71 participants at risk
Post treatment follow up period: Participants who received 3 mg LY3372689 during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring.
Post treatment observational extension period: Participants who received 3 mg LY3372689 during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.
|
Placebo (Post-treatment Follow up Period and Post Treatment Observational Extension Period)
n=88 participants at risk
Post treatment follow up period: Participants who received placebo during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring.
Post treatment observational extension period: Participants who received placebo during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.8%
3/108 • Number of events 3 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
5.5%
6/110 • Number of events 6 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
2.8%
3/108 • Number of events 3 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
13/108 • Number of events 18 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
10.9%
12/110 • Number of events 17 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
11.1%
12/108 • Number of events 14 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
6/108 • Number of events 6 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.8%
2/110 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.93%
1/108 • Number of events 1 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
6.5%
7/108 • Number of events 8 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
7.3%
8/110 • Number of events 11 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
6.5%
7/108 • Number of events 8 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
1.9%
2/108 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
5.5%
6/110 • Number of events 6 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
4.6%
5/108 • Number of events 5 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
22.2%
24/108 • Number of events 27 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
15.5%
17/110 • Number of events 18 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
21.3%
23/108 • Number of events 24 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
5/108 • Number of events 5 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
6.4%
7/110 • Number of events 8 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
8.3%
9/108 • Number of events 10 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.0%
14/108 • Number of events 17 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
10.0%
11/110 • Number of events 13 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
7.4%
8/108 • Number of events 8 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
7.4%
8/108 • Number of events 11 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
7.3%
8/110 • Number of events 13 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
12.0%
13/108 • Number of events 21 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
18.5%
20/108 • Number of events 28 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
14.5%
16/110 • Number of events 37 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
13.9%
15/108 • Number of events 19 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Investigations
Electrocardiogram pr prolongation
|
3.7%
4/108 • Number of events 10 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
7.3%
8/110 • Number of events 15 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
4.6%
5/108 • Number of events 6 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Investigations
Electrocardiogram qt prolonged
|
7.4%
8/108 • Number of events 15 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
9.1%
10/110 • Number of events 15 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
4.6%
5/108 • Number of events 10 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
5.6%
6/108 • Number of events 6 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
7.3%
8/110 • Number of events 9 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
3.7%
4/108 • Number of events 4 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
9/108 • Number of events 11 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
3.6%
4/110 • Number of events 5 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
6.5%
7/108 • Number of events 7 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
9/108 • Number of events 10 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
4.5%
5/110 • Number of events 5 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
5.6%
6/108 • Number of events 6 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.7%
4/108 • Number of events 4 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
5.5%
6/110 • Number of events 6 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
2.8%
3/108 • Number of events 3 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
6/108 • Number of events 7 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.8%
2/110 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
5.6%
6/108 • Number of events 6 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
6.5%
7/108 • Number of events 9 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
7.3%
8/110 • Number of events 13 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
8.3%
9/108 • Number of events 9 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
14.8%
16/108 • Number of events 89 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
11.8%
13/110 • Number of events 15 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
5.6%
6/108 • Number of events 6 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
3.7%
4/108 • Number of events 4 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
5.5%
6/110 • Number of events 8 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.9%
2/108 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
7.4%
8/108 • Number of events 9 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
7.3%
8/110 • Number of events 8 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
4.6%
5/108 • Number of events 9 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
6.5%
7/108 • Number of events 8 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.8%
2/110 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
2.8%
3/108 • Number of events 3 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
5.0%
2/40 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/29 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/35 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
7/108 • Number of events 8 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
2.7%
3/110 • Number of events 3 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
5.6%
6/108 • Number of events 8 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
1.9%
2/108 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
1.8%
2/110 • Number of events 2 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
8.3%
9/108 • Number of events 11 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/83 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/71 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
0.00%
0/88 • Up to 124 weeks (Double-blind treatment period); 9 months on average (Post-treatment follow-up and Post treatment observational extension period)
Safety population for double-blind treatment period includes all randomized participants (pts) who received at least one dose of study drug. For post-treatment period,safety population includes all pts with safety data from post-treatment follow-up period and/or post-treatment observational extension period. Per statistical analysis plan,safety data from these two periods were pooled for adverse event analyses.Gender-specific events have had number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60