Trial Outcomes & Findings for Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss (NCT NCT02008357)
NCT ID: NCT02008357
Last Updated: 2023-12-28
Results Overview
PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-96 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: Digit Symbol Substitution Test (DSST): (ranges 0 \[none\]-91 \[best performance\]) and Mini Mental State Examination (Range 0 \[worst\] - 30 \[best performance\]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1169 participants
Primary outcome timeframe
Baseline, Week approximately 240
Results posted on
2023-12-28
Participant Flow
Per protocol and statistical analysis plan (SAP), delayed-start analyses were not conducted because no treatment difference was observed at the end of the double-blind (placebo-controlled) period. Hence, data were not evaluated for outcome measure analyses (week 336), but safety data were analyzed for open-label extension period.
Participant milestones
| Measure |
Solanezumab/Solanezumab
Participants received 400 milligram (mg) solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered intravenously (IV) every 4 weeks (Q4W) for approximately 240 weeks in double-blind (placebo-controlled) period.
Participants begin open label extension period and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).
|
Placebo/Solanezumab
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
Participants begin open label extension period and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).
|
|---|---|---|
|
Double-blind (Placebo Controlled) Period
STARTED
|
578
|
591
|
|
Double-blind (Placebo Controlled) Period
COMPLETED
|
406
|
424
|
|
Double-blind (Placebo Controlled) Period
NOT COMPLETED
|
172
|
167
|
|
Open-label Extension Period
STARTED
|
383
|
401
|
|
Open-label Extension Period
COMPLETED
|
1
|
1
|
|
Open-label Extension Period
NOT COMPLETED
|
382
|
400
|
Reasons for withdrawal
| Measure |
Solanezumab/Solanezumab
Participants received 400 milligram (mg) solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered intravenously (IV) every 4 weeks (Q4W) for approximately 240 weeks in double-blind (placebo-controlled) period.
Participants begin open label extension period and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).
|
Placebo/Solanezumab
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
Participants begin open label extension period and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).
|
|---|---|---|
|
Double-blind (Placebo Controlled) Period
Adverse Event
|
29
|
35
|
|
Double-blind (Placebo Controlled) Period
Withdrawal by Subject
|
101
|
88
|
|
Double-blind (Placebo Controlled) Period
Death
|
6
|
5
|
|
Double-blind (Placebo Controlled) Period
Lack of Efficacy
|
3
|
4
|
|
Double-blind (Placebo Controlled) Period
Lost to Follow-up
|
3
|
6
|
|
Double-blind (Placebo Controlled) Period
Coordinating Center Request
|
1
|
0
|
|
Double-blind (Placebo Controlled) Period
Covid-19 Pandemic Disruption
|
6
|
3
|
|
Double-blind (Placebo Controlled) Period
Investigator Recommendation
|
2
|
2
|
|
Double-blind (Placebo Controlled) Period
Non-Compliance
|
1
|
1
|
|
Double-blind (Placebo Controlled) Period
Non-Site Clinician Recommendation
|
2
|
0
|
|
Double-blind (Placebo Controlled) Period
Safety Risk
|
2
|
6
|
|
Double-blind (Placebo Controlled) Period
Started Prohibited Medication
|
0
|
1
|
|
Double-blind (Placebo Controlled) Period
Starting A New Treatment For Alzheimer's Disease
|
1
|
1
|
|
Double-blind (Placebo Controlled) Period
Starting New Trial
|
2
|
0
|
|
Double-blind (Placebo Controlled) Period
Study Partner Unwilling Or Unable To Participate
|
3
|
1
|
|
Double-blind (Placebo Controlled) Period
Family Issues
|
1
|
1
|
|
Double-blind (Placebo Controlled) Period
Subject Relocated to Another Place
|
4
|
2
|
|
Double-blind (Placebo Controlled) Period
Subject's Expectation From Study Were not Aligned
|
0
|
3
|
|
Double-blind (Placebo Controlled) Period
Personal Reason
|
0
|
1
|
|
Double-blind (Placebo Controlled) Period
Discontinued Study due to Health Issues
|
3
|
0
|
|
Double-blind (Placebo Controlled) Period
Site Closure
|
0
|
1
|
|
Double-blind (Placebo Controlled) Period
Medical Health of Study Partner
|
0
|
1
|
|
Double-blind (Placebo Controlled) Period
No Longer Wishes to Participate
|
1
|
2
|
|
Double-blind (Placebo Controlled) Period
Subject Concurrently Enrolled in Another Clinical Drug Trial
|
0
|
1
|
|
Double-blind (Placebo Controlled) Period
Starting Another Treatment for the Disease
|
0
|
1
|
|
Double-blind (Placebo Controlled) Period
Decision was Taken by Subject's Personal Doctor
|
1
|
0
|
|
Double-blind (Placebo Controlled) Period
Inability to have MRI due to Stimulator Implant
|
0
|
1
|
|
Open-label Extension Period
Adverse Event
|
8
|
7
|
|
Open-label Extension Period
Death
|
7
|
4
|
|
Open-label Extension Period
Lack of Efficacy
|
9
|
5
|
|
Open-label Extension Period
Lost to Follow-up
|
2
|
2
|
|
Open-label Extension Period
Withdrawal by Subject
|
27
|
32
|
|
Open-label Extension Period
Study Terminated By Sponsor
|
300
|
313
|
|
Open-label Extension Period
Safety Risk
|
2
|
1
|
|
Open-label Extension Period
Non-Compliance
|
0
|
1
|
|
Open-label Extension Period
Investigator Recommendation
|
0
|
1
|
|
Open-label Extension Period
Covid-19 Pandemic Disruption
|
0
|
1
|
|
Open-label Extension Period
Coordinating Center Request
|
2
|
4
|
|
Open-label Extension Period
No Longer Wishes to Participate
|
1
|
1
|
|
Open-label Extension Period
Study Ended
|
20
|
25
|
|
Open-label Extension Period
Personal Reasons
|
0
|
1
|
|
Open-label Extension Period
Discontinued Study Due to Health Issues
|
0
|
2
|
|
Open-label Extension Period
Travel Issues/Limitations
|
2
|
0
|
|
Open-label Extension Period
Other
|
2
|
0
|
Baseline Characteristics
PACC z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement. Analysis population description included all randomized participants who had baseline PACC total score data.
Baseline characteristics by cohort
| Measure |
Solanezumab/Solanezumab
n=578 Participants
Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
Participants begin open label extension and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).
|
Placebo/Solanezumab
n=591 Participants
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
Participants begin open label extension period and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).
|
Total
n=1169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 4.6 • n=578 Participants
|
71.9 years
STANDARD_DEVIATION 5.0 • n=591 Participants
|
71.9 years
STANDARD_DEVIATION 4.8 • n=1169 Participants
|
|
Sex: Female, Male
Female
|
337 Participants
n=578 Participants
|
357 Participants
n=591 Participants
|
694 Participants
n=1169 Participants
|
|
Sex: Female, Male
Male
|
241 Participants
n=578 Participants
|
234 Participants
n=591 Participants
|
475 Participants
n=1169 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=578 Participants
|
18 Participants
n=591 Participants
|
34 Participants
n=1169 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
556 Participants
n=578 Participants
|
568 Participants
n=591 Participants
|
1124 Participants
n=1169 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=578 Participants
|
5 Participants
n=591 Participants
|
11 Participants
n=1169 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=578 Participants
|
1 Participants
n=591 Participants
|
2 Participants
n=1169 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=578 Participants
|
13 Participants
n=591 Participants
|
24 Participants
n=1169 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=578 Participants
|
0 Participants
n=591 Participants
|
0 Participants
n=1169 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=578 Participants
|
16 Participants
n=591 Participants
|
28 Participants
n=1169 Participants
|
|
Race (NIH/OMB)
White
|
545 Participants
n=578 Participants
|
555 Participants
n=591 Participants
|
1100 Participants
n=1169 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=578 Participants
|
3 Participants
n=591 Participants
|
8 Participants
n=1169 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=578 Participants
|
3 Participants
n=591 Participants
|
7 Participants
n=1169 Participants
|
|
Region of Enrollment
Canada
|
26 Participants
n=578 Participants
|
22 Participants
n=591 Participants
|
48 Participants
n=1169 Participants
|
|
Region of Enrollment
United States
|
497 Participants
n=578 Participants
|
513 Participants
n=591 Participants
|
1010 Participants
n=1169 Participants
|
|
Region of Enrollment
Japan
|
9 Participants
n=578 Participants
|
8 Participants
n=591 Participants
|
17 Participants
n=1169 Participants
|
|
Region of Enrollment
Australia
|
46 Participants
n=578 Participants
|
48 Participants
n=591 Participants
|
94 Participants
n=1169 Participants
|
|
Preclinical Alzheimer Cognitive Composite (PACC) Total Score
|
0.01 score on a scale
STANDARD_DEVIATION 2.76 • n=572 Participants • PACC z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement. Analysis population description included all randomized participants who had baseline PACC total score data.
|
0.01 score on a scale
STANDARD_DEVIATION 2.60 • n=591 Participants • PACC z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement. Analysis population description included all randomized participants who had baseline PACC total score data.
|
0.01 score on a scale
STANDARD_DEVIATION 2.68 • n=1163 Participants • PACC z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement. Analysis population description included all randomized participants who had baseline PACC total score data.
|
PRIMARY outcome
Timeframe: Baseline, Week approximately 240Population: All randomized participants who have a baseline score and at least 1 post-baseline assessment. Least square mean (LS) mean was derived using natural cubic spline models with factors for treatment, time, and covariates = age, baseline florbetapir cortical standardized uptake value ratio (SUVr) score, years of education, APOE4 carrier status (n),pacc components version type.
PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-96 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: Digit Symbol Substitution Test (DSST): (ranges 0 \[none\]-91 \[best performance\]) and Mini Mental State Examination (Range 0 \[worst\] - 30 \[best performance\]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement.
Outcome measures
| Measure |
Solanezumab
n=403 Participants
Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
Placebo
n=426 Participants
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
|---|---|---|
|
Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score
|
-1.43 score on a scale
Standard Error 0.21
|
-1.13 score on a scale
Standard Error 0.16
|
PRIMARY outcome
Timeframe: Baseline, Week 336Population: Zero participants analyzed. Delayed-start analyses were not conducted because no treatment difference was observed at the end of the placebo-controlled period. Hence, data were not evaluated for outcome measure analyses (week 336) in open-label extension period.
PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-96 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: Digit Symbol Substitution Test (DSST): (ranges 0 \[none\]-91 \[best performance\]) and Mini Mental State Examination (Range 0 \[worst\] - 30 \[best performance\]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week approximately 240Population: All randomized participants who have a baseline score and at least 1 post-baseline assessment.
The CFI is a modified version of the Mail-in Cognitive Function Screening Instrument, a participant- and study partner/informant-reported outcome measure developed by the Alzheimer's Disease Cooperative Study (ADCS). This assessment includes 15 questions (14 of which contribute to the total score, and 1 additional unscored item) that assess the participant's perceived ability to perform high-level functional tasks in daily-life and sense of overall cognitive functional ability. Study participants and their informants independently rate the participant's abilities. A total score is calculated by combining participant-reported and an informant-reported scores, and ranges from 0 to 14 (yes=1; no=0; maybe=0.5 for each question) with higher scores indicating greater impairment. LS mean was derived using natural cubic spline models with factors for treatment, time, and covariates = age, baseline florbetapir cortical SUVr score, years of education, APOE4 carrier status (n).
Outcome measures
| Measure |
Solanezumab
n=408 Participants
Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
Placebo
n=422 Participants
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
|---|---|---|
|
Change From Baseline in Cognitive Function Index (CFI)
|
1.94 score on a scale
Standard Error 0.20
|
1.47 score on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline, Week 336Population: Zero participants analyzed. Delayed-start analyses were not conducted because no treatment difference was observed at the end of the placebo-controlled period. Hence, data were not evaluated for outcome measure analyses (week 336) in open-label extension period.
The CFI is a modified version of the Mail-in Cognitive Function Screening Instrument, a participant- and study partner/informant-reported outcome measure developed by the ADCS. This assessment includes 15 questions (14 of which contribute to the total score, and 1 additional unscored item) that assess the participant's perceived ability to perform high-level functional tasks in daily-life and sense of overall cognitive functional ability. Study participants and their informants independently rate the participant's abilities. A total score is calculated by combining participant-reported and an informant-reported scores, and ranges from 0 to 14 (yes=1; no=0; maybe=0.5 for each question) with higher scores indicating greater impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week approximately 240Population: All randomized participants who have a baseline score and at least 1 post-baseline assessment. LS mean was derived using natural cubic spline models with factors for treatment, time, and covariates = age, baseline florbetapir cortical SUVr score, years of education, APOE4 carrier status (n).
The ADCS-ADL-prevention questionnaire is a functional measure composed of 18 items that includes 15 activities of daily living rated on a 4-point scale and 3 high level function items. Study participants and their informants independently rate the participant's level of ability (with no difficulty = 3, with some difficulty = 2, with a lot of difficulty = 1, did not do/don't know = 0). Informants are additionally asked to evaluate whether activities were completed less often, required more time to complete, and if any errors were made performing the task. High-level function items are rated as "yes" or "no". The total score is the sum of the scores of the 15 activities of daily living questions (range: 0-45) with higher scores indicating less impairment.
Outcome measures
| Measure |
Solanezumab
n=408 Participants
Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
Placebo
n=423 Participants
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
|---|---|---|
|
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score
|
-2.29 score on a scale
Standard Error 0.24
|
-1.70 score on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline, Week 336Population: Zero participants analyzed. Delayed-start analyses were not conducted because no treatment difference was observed at the end of the placebo-controlled period. Hence, data were not evaluated for outcome measure analyses (week 336) in open-label extension period.
The ADCS-ADL-prevention questionnaire is a functional measure composed of 18 items that includes 15 activities of daily living rated on a 4-point scale and 3 high level function items. Study participants and their informants independently rate the participant's level of ability (with no difficulty = 3, with some difficulty = 2, with a lot of difficulty = 1, did not do/don't know = 0). Informants are additionally asked to evaluate whether activities were completed less often, required more time to complete, and if any errors were made performing the task. High-level function items are rated as "yes" or "no". The scores range from 0 to 45 with higher scores indicating less impairment. The total score is the sum of the scores of the 15 activities of daily living questions (range: 0-45) with higher scores indicating less impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week approximately 240Population: All randomized participants who have a baseline score and at least 1 post-baseline assessment.
Deposition of abnormal tau protein in the brain associated with AD was assessed by quantitative positron emission tomography (PET) scan using flortaucipir F-18. Flortaucipir is an F-18-labeled small molecule that binds with high affinity and selectivity to aggregated tau, and provides a measure of aggregated tau deposition in the brain, expressed as flortaucipir SUVr. LS Mean was calculated using an analysis of covariance (ANCOVA) model with fixed effects of baseline florbetapir result, treatment, APOE4 Carrier Status (yes/no), and age at baseline
Outcome measures
| Measure |
Solanezumab
n=462 Participants
Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
Placebo
n=477 Participants
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
|---|---|---|
|
Change From Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr)
|
0.066 standardized uptake value ratio (SUVr)
Standard Error 0.0052
|
0.108 standardized uptake value ratio (SUVr)
Standard Error 0.0051
|
SECONDARY outcome
Timeframe: Baseline, Week approximately 240Population: All randomized participants who have a baseline score and at least 1 post-baseline assessment.
CSF concentrations of total tau and tau phosphorylated protein concentrations were analyzed using validated Immunoassay method. LS mean was derived using an analysis of covariance (ANCOVA) model with fixed effects of baseline CSF, treatment, APOE4 Carrier Status (yes/no) and age at baseline.
Outcome measures
| Measure |
Solanezumab
n=48 Participants
Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
Placebo
n=52 Participants
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
|---|---|---|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers
CSF Tau Protein
|
-17.201 nanograms per liter (ng/L)
Standard Error 23.5807
|
-20.440 nanograms per liter (ng/L)
Standard Error 22.6457
|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers
CSF Phosphorylated Tau Protein
|
10.266 nanograms per liter (ng/L)
Standard Error 1.8792
|
11.231 nanograms per liter (ng/L)
Standard Error 1.8371
|
SECONDARY outcome
Timeframe: Baseline, Week approximately 240Population: All randomized participants who have a baseline score and at least 1 post-baseline assessment.
CSF biomarker concentrations were analyzed for Aβ 1-40 and Aβ 1-42 using Innotest Enzyme-linked immunosorbent assays (ELISA) method. LS mean was derived using an ANCOVA model with fixed effects of baseline CSF, treatment, APOE4 Carrier Status (yes/no) and age at baseline.
Outcome measures
| Measure |
Solanezumab
n=51 Participants
Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
Placebo
n=54 Participants
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
|---|---|---|
|
Change From Baseline of Cerebrospinal Fluid (CSF) Concentrations of Amyloid Beta (Aβ)
CSF Amyloid Beta 1-40 Modified ELISA - INNOTEST
|
12151.386 nanograms per liter (ng/L)
Standard Error 711.6120
|
-587.063 nanograms per liter (ng/L)
Standard Error 691.2989
|
|
Change From Baseline of Cerebrospinal Fluid (CSF) Concentrations of Amyloid Beta (Aβ)
CSF Amyloid Beta 1-42 Mod Modified ELISA - INNOTEST
|
1045.570 nanograms per liter (ng/L)
Standard Error 42.6843
|
49.160 nanograms per liter (ng/L)
Standard Error 42.2627
|
SECONDARY outcome
Timeframe: Baseline, Week approximately 240Population: All randomized participants who have a baseline score and at least 1 post-baseline assessment.
Alzheimer's disease is also associated with pronounced brain atrophy, reflecting bulk neurodegenerative loss of gray and white matter. Progression of brain atrophy is assessed by vMRI, providing regional quantification of volume loss. Negative change from baseline indicates greater disease severity. Total hippocampal volume and Total Lateral Ventricular Volume were analyzed for vMRI parameters. LS mean was derived using an ANCOVA model with fixed effects of baseline vMRI value, treatment, age at baseline, education, APOE4 Carrier Status (yes/no), and baseline florbetapir cortical SUVr.
Outcome measures
| Measure |
Solanezumab
n=561 Participants
Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
Placebo
n=578 Participants
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
|---|---|---|
|
Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
Total hippocampal volume
|
-0.369 cubic centimeter (cm^3)
Standard Error 0.0276
|
-0.314 cubic centimeter (cm^3)
Standard Error 0.0272
|
|
Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
Total Lateral Ventricular Volume
|
9.329 cubic centimeter (cm^3)
Standard Error 0.3215
|
8.978 cubic centimeter (cm^3)
Standard Error 0.3167
|
SECONDARY outcome
Timeframe: Baseline, Week 336Population: Zero participants analyzed. Delayed-start analyses were not conducted because no treatment difference was observed at the end of the placebo-controlled period. Hence, data were not evaluated for outcome measure analyses (week 336) in open-label extension period.
The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18. Higher score indicates severe impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 336Population: Zero participants analyzed. Delayed-start analyses were not conducted because no treatment difference was observed at the end of the placebo-controlled period. Hence, data were not evaluated for outcome measure analyses (week 336) in open-label extension period.
The C3 includes tasks from the CogState battery aimed at measuring processing speed, working memory, visual navigation, and executive function. The C3 also include 2 investigator-developed sensitive episodic memory probes of hippocampal function. A composite score is generated and CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions.
Outcome measures
Outcome data not reported
Adverse Events
Solanezumab: Double-blind (Placebo Controlled) Period
Serious events: 171 serious events
Other events: 531 other events
Deaths: 6 deaths
Placebo: Double-blind (Placebo Controlled) Period
Serious events: 156 serious events
Other events: 554 other events
Deaths: 7 deaths
Solanezumab/Solanezumab: Open-label Extension Period
Serious events: 51 serious events
Other events: 286 other events
Deaths: 7 deaths
Placebo/Solanezumab: Open-label Extension Period
Serious events: 70 serious events
Other events: 310 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Solanezumab: Double-blind (Placebo Controlled) Period
n=572 participants at risk
Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
Placebo: Double-blind (Placebo Controlled) Period
n=591 participants at risk
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
Solanezumab/Solanezumab: Open-label Extension Period
n=383 participants at risk
Participants who received solanezumab in double-blind period were administered 1600 mg solanezumab IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.
|
Placebo/Solanezumab: Open-label Extension Period
n=401 participants at risk
Participants who received placebo in double-blind period were administered 1600 mg solanezumab IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.35%
2/572 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.52%
2/383 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiogenic shock
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymph node rupture
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.52%
3/572 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
4/591 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
3/383 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina pectoris
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina unstable
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
9/572 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
9/591 • Number of events 11 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial flutter
|
0.52%
3/572 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Brash syndrome
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure acute
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Left ventricular failure
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
7/591 • Number of events 7 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Sinus bradycardia
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Visual impairment
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diverticulum
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.52%
3/572 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.70%
4/572 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Cyst
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Death
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Medical device site photosensitivity reaction
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Medical device site reaction
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.52%
3/572 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic cyst ruptured
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Hypersensitivity
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abscess limb
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abscess of salivary gland
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Arthritis infective
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bacterial colitis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Breast abscess
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Breast cellulitis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
4/591 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.52%
2/383 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Ear infection staphylococcal
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Epididymitis
|
0.42%
1/238 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/234 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/162 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/163 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Infection
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Localised infection
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Lyme disease
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Meningitis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Metapneumovirus pneumonia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Osteomyelitis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.52%
3/572 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
9/591 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.75%
3/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Postoperative wound infection
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Rocky mountain spotted fever
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
4/591 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.75%
3/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Septic shock
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Staphylococcal infection
|
0.17%
1/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/383 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urosepsis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vestibular neuronitis
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Viral labyrinthitis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Central cord syndrome
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
7/572 • Number of events 7 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
6/591 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/383 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
5/401 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.52%
2/383 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.52%
3/572 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.52%
2/383 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
3/591 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.52%
2/383 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
4/591 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.75%
3/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.52%
2/383 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
3/591 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.52%
3/572 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.52%
3/572 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
3/591 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood pressure diastolic decreased
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Chest x-ray abnormal
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.52%
3/572 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.52%
3/572 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
4/591 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.17%
1/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.75%
3/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
7/572 • Number of events 8 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
7/591 • Number of events 8 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
6/401 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
3/591 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Subchondral insufficiency fracture
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Symphysiolysis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dedifferentiated liposarcoma
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.52%
3/572 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative neoplasm
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.30%
1/334 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/357 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/221 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/334 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.28%
1/357 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/221 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/238 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage iii
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.5%
6/238 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.43%
1/234 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.62%
1/162 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/163 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage ii
|
0.00%
0/238 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.43%
1/234 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/162 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/163 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Ataxia
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Basal ganglia stroke
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral infarction
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.52%
3/572 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.75%
3/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Facial paralysis
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
3/591 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Partial seizures
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Presyncope
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Sciatica
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Seizure
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Sensory loss
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Superficial siderosis of central nervous system
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
1.0%
6/572 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
3/591 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Transient global amnesia
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.70%
4/572 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
4/591 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Vith nerve paralysis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Product Issues
Device dislocation
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Delirium
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Mental status changes
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Calculus bladder
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
0.17%
1/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.52%
3/572 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal cyst
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Urethral disorder
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.52%
2/383 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.3%
3/238 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/234 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.62%
1/162 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.61%
1/163 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.42%
1/238 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.43%
1/234 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/162 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/163 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal leukoplakia
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mass
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
4/591 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Closed fracture manipulation
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Colectomy
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Ileostomy
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Lung lobectomy
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.42%
1/238 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/234 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/162 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/163 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
2/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Aortic stenosis
|
0.35%
2/572 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.52%
3/572 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
3/591 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertensive urgency
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
0.17%
1/572 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
3/383 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/591 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/572 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.17%
1/591 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
Solanezumab: Double-blind (Placebo Controlled) Period
n=572 participants at risk
Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
Placebo: Double-blind (Placebo Controlled) Period
n=591 participants at risk
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.
|
Solanezumab/Solanezumab: Open-label Extension Period
n=383 participants at risk
Participants who received solanezumab in double-blind period were administered 1600 mg solanezumab IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.
|
Placebo/Solanezumab: Open-label Extension Period
n=401 participants at risk
Participants who received placebo in double-blind period were administered 1600 mg solanezumab IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
19/572 • Number of events 19 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.1%
24/591 • Number of events 27 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/383 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
9/401 • Number of events 12 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.6%
9/572 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
20/591 • Number of events 20 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
5.8%
33/572 • Number of events 35 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.6%
27/591 • Number of events 29 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
11/383 • Number of events 13 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
5/401 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
10.7%
61/572 • Number of events 82 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
74/591 • Number of events 99 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
18/383 • Number of events 21 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.0%
24/401 • Number of events 30 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.1%
18/572 • Number of events 20 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
12/591 • Number of events 14 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/383 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
5/401 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
26/572 • Number of events 28 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
18/591 • Number of events 19 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
6/383 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
10/401 • Number of events 10 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dental caries
|
2.4%
14/572 • Number of events 18 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
21/591 • Number of events 24 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.75%
3/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
78/572 • Number of events 91 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.2%
78/591 • Number of events 99 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
17/383 • Number of events 17 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
18/401 • Number of events 19 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.4%
31/572 • Number of events 33 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
38/591 • Number of events 40 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
9/383 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
8/401 • Number of events 8 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
5.8%
33/572 • Number of events 36 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.2%
31/591 • Number of events 33 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
11/383 • Number of events 15 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.00%
4/401 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chest pain
|
3.7%
21/572 • Number of events 22 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
15/591 • Number of events 15 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
7/383 • Number of events 8 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
5/401 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
9.8%
56/572 • Number of events 72 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.6%
45/591 • Number of events 52 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
7/383 • Number of events 7 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
7/401 • Number of events 7 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
4.0%
23/572 • Number of events 26 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
19/591 • Number of events 19 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
6/383 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
5.1%
29/572 • Number of events 31 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.1%
24/591 • Number of events 26 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/383 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.75%
3/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
8.7%
50/572 • Number of events 61 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.5%
62/591 • Number of events 72 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
11/383 • Number of events 11 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
8/401 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
4.7%
27/572 • Number of events 35 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.6%
27/591 • Number of events 30 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
6/383 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
6/401 • Number of events 7 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
1.9%
11/572 • Number of events 14 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
20/591 • Number of events 24 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
6/383 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
3.8%
22/572 • Number of events 22 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
22/591 • Number of events 22 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
27.4%
105/383 • Number of events 111 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
26.9%
108/401 • Number of events 113 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
4.0%
23/572 • Number of events 23 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
21/591 • Number of events 26 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.52%
2/383 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
5/401 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
3.3%
19/572 • Number of events 21 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.1%
24/591 • Number of events 25 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
6/383 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.75%
3/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
8.6%
49/572 • Number of events 53 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
42/591 • Number of events 47 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/383 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.75%
3/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
20.5%
117/572 • Number of events 172 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
20.5%
121/591 • Number of events 183 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
12/383 • Number of events 12 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.2%
17/401 • Number of events 18 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
4.0%
23/572 • Number of events 24 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
26/591 • Number of events 28 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
3/383 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
11/401 • Number of events 11 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
10.3%
59/572 • Number of events 78 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
74/591 • Number of events 94 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
14/383 • Number of events 16 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
9/401 • Number of events 10 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tooth abscess
|
2.4%
14/572 • Number of events 16 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
26/591 • Number of events 32 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tooth infection
|
2.8%
16/572 • Number of events 17 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
18/591 • Number of events 21 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/383 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
5/401 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
30.4%
174/572 • Number of events 298 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.5%
198/591 • Number of events 348 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.7%
41/383 • Number of events 50 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.5%
46/401 • Number of events 54 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
82/572 • Number of events 149 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.6%
92/591 • Number of events 139 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.9%
34/383 • Number of events 49 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.7%
35/401 • Number of events 50 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.7%
27/572 • Number of events 33 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.6%
39/591 • Number of events 50 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
3/383 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.75%
3/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.7%
21/572 • Number of events 26 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
30/591 • Number of events 32 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
3/383 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
8/401 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.3%
59/572 • Number of events 77 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.5%
56/591 • Number of events 64 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.6%
10/383 • Number of events 11 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
9/401 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
29.7%
170/572 • Number of events 266 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
26.4%
156/591 • Number of events 278 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
17.2%
66/383 • Number of events 90 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
17.7%
71/401 • Number of events 95 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.4%
31/572 • Number of events 34 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.8%
40/591 • Number of events 43 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
6/383 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
7/401 • Number of events 7 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
3.1%
18/572 • Number of events 19 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
18/591 • Number of events 20 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
7.5%
43/572 • Number of events 46 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.3%
37/591 • Number of events 39 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
9/383 • Number of events 11 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
8/401 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.9%
34/572 • Number of events 42 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
28/591 • Number of events 36 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
3/383 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
5/401 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
7.2%
41/572 • Number of events 44 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.0%
53/591 • Number of events 59 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
11/383 • Number of events 12 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.5%
14/401 • Number of events 20 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
2.6%
15/572 • Number of events 16 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
28/591 • Number of events 32 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
5/401 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
1.2%
7/572 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.4%
14/591 • Number of events 15 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
12/383 • Number of events 12 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
5/401 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.4%
14/572 • Number of events 15 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
20/591 • Number of events 20 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/383 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/401 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.3%
13/572 • Number of events 13 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
18/591 • Number of events 19 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.52%
2/383 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.75%
3/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.9%
114/572 • Number of events 153 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
19.8%
117/591 • Number of events 153 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.2%
39/383 • Number of events 45 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.7%
35/401 • Number of events 41 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.9%
34/572 • Number of events 37 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.8%
34/591 • Number of events 37 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
6/383 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
5/401 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.5%
77/572 • Number of events 88 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.2%
78/591 • Number of events 90 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.0%
23/383 • Number of events 23 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.5%
14/401 • Number of events 14 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
3.3%
19/572 • Number of events 19 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.1%
24/591 • Number of events 27 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/383 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
5/401 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.8%
39/572 • Number of events 44 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
32/591 • Number of events 34 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
3/383 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.75%
3/401 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
29/572 • Number of events 32 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
22/591 • Number of events 23 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
6/383 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.00%
4/401 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.4%
25/572 • Number of events 25 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
20/591 • Number of events 21 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/383 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
8/401 • Number of events 8 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
8.7%
50/572 • Number of events 55 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.6%
57/591 • Number of events 66 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
13/383 • Number of events 16 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
12/401 • Number of events 13 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.5%
20/572 • Number of events 20 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
21/591 • Number of events 21 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/383 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.25%
1/401 • Number of events 1 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
47/572 • Number of events 56 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.0%
53/591 • Number of events 64 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
19/383 • Number of events 20 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
13/401 • Number of events 14 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
3.7%
21/572 • Number of events 22 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
17/591 • Number of events 17 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/383 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
9/401 • Number of events 12 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
8.2%
47/572 • Number of events 71 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.0%
53/591 • Number of events 90 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
13/383 • Number of events 15 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.2%
17/401 • Number of events 33 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
5.6%
32/572 • Number of events 39 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.9%
29/591 • Number of events 53 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
19/383 • Number of events 22 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
9/401 • Number of events 19 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Balance disorder
|
2.6%
15/572 • Number of events 16 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
19/591 • Number of events 21 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/383 • Number of events 7 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
4.0%
23/572 • Number of events 27 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.9%
41/591 • Number of events 51 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
6/383 • Number of events 8 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
11/401 • Number of events 13 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cognitive disorder
|
8.7%
50/572 • Number of events 50 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
33/591 • Number of events 33 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.6%
10/383 • Number of events 10 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
18/401 • Number of events 18 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
13.8%
79/572 • Number of events 95 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.5%
62/591 • Number of events 72 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
19/383 • Number of events 21 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
15/401 • Number of events 20 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
19.6%
112/572 • Number of events 158 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
20.0%
118/591 • Number of events 157 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.7%
22/383 • Number of events 24 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.0%
24/401 • Number of events 27 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Memory impairment
|
4.0%
23/572 • Number of events 23 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
16/591 • Number of events 18 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.52%
2/383 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.00%
4/401 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
3.1%
18/572 • Number of events 20 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.2%
25/591 • Number of events 32 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/383 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.00%
4/401 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Sciatica
|
5.6%
32/572 • Number of events 39 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
21/591 • Number of events 25 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/383 • Number of events 5 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.00%
4/401 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
6.6%
38/572 • Number of events 40 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
33/591 • Number of events 33 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
17/383 • Number of events 18 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
10/401 • Number of events 11 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
6.1%
35/572 • Number of events 35 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
38/591 • Number of events 40 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
6/383 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
9/401 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
5.9%
34/572 • Number of events 36 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.1%
36/591 • Number of events 37 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
8/383 • Number of events 8 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
13/401 • Number of events 14 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
5.9%
14/238 • Number of events 16 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
13/234 • Number of events 13 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
4/162 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
7/163 • Number of events 7 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
43/572 • Number of events 50 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.5%
50/591 • Number of events 60 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
9/383 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
9/401 • Number of events 9 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
13/572 • Number of events 13 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
21/591 • Number of events 23 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
3/383 • Number of events 3 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.00%
4/401 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.3%
13/572 • Number of events 14 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
19/591 • Number of events 21 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/383 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
4.5%
26/572 • Number of events 35 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
28/591 • Number of events 31 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/383 • Number of events 8 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
6/401 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.1%
29/572 • Number of events 34 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
26/591 • Number of events 34 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
6/383 • Number of events 6 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
15/572 • Number of events 19 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.1%
24/591 • Number of events 27 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/383 • Number of events 4 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.50%
2/401 • Number of events 2 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.8%
56/572 • Number of events 63 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.6%
39/591 • Number of events 49 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
12/383 • Number of events 15 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
9/401 • Number of events 10 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
10.1%
58/572 • Number of events 63 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
59/591 • Number of events 61 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
17/383 • Number of events 17 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
16/401 • Number of events 18 • Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the 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