Trial Outcomes & Findings for Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis (NCT NCT02201108)
NCT ID: NCT02201108
Last Updated: 2025-02-06
Results Overview
Time to first clinical relapse was defined as the duration (in weeks) between randomization and first confirmed clinical relapse. Clinical relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon neurological examination and documented by a standardized, quantified functional system score (FSSs) which included 8 items and items were rated on different scales: brain stem, cerebellar and cerebral functions rated on a scale of 0 to 5; visual, pyramidal, sensory and bowel/bladder rated on a scale of 0 to 6 and ambulation on a scale of 0 to 12, where higher score in each scale indicated worsened neurological function. Confirmed clinical relapse were reviewed and confirmed by an independent Relapse Adjudication Panel (RAP). A participant without confirmed clinical relapse, was considered as clinical relapse free until the end of Week 96.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
166 participants
Primary outcome timeframe
Baseline up to Week 96
Results posted on
2025-02-06
Participant Flow
Study was conducted at 57 active centers in 21 countries. A total of 185 participants were screened between 16 July 2014 and 27 December 2017, of which 166 participants were enrolled and randomized. A total of 19 participants failed screening mainly due to meeting exclusion criteria.
Participants were randomly assigned to receive either teriflunomide or placebo in a 2:1 ratio via Interactive Voice Response System. Randomization was stratified by the country and participant's pubertal status.
Participant milestones
| Measure |
Placebo/Teriflunomide
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in double blind (DB) treatment period. After completion of DB period, eligible participants entered in open label (OL) period and received 1 teriflunomide tablet, 3.5 milligrams (mg) (in case of body weight \[BW\] up to 40 kilograms \[kg\]) or 7 mg (BW greater than \[\>\] 40 kg) for first 8 weeks. After 8 weeks if individual predicted PK parameter was less than or equal to (\<=) 95th percentile of adult range after 7 mg once daily, then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW\>40 kg) in the OL period for additional 96 weeks (i.e., up to Week 192). If individual predicted PK parameters \>95th percentile of adult range then participant received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).The adult range (5th-95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as maximum concentration observed (Cmax) ranging from 8.03 to 49.10 micrograms per milliliter (mcg/mL) and area under the curve from time 0 hour to 24 hours (AUC0-24) ranging from 184 to 1160 micrograms\*hour per milliliter (mcg\*h/mL).
|
Teriflunomide/Teriflunomide
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily, then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL. After completion of DB period, eligible participants entered in OL period and continued receiving teriflunomide at the same dose in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide
Participants who were not adults when they completed the 192-week OL period were offered an optional additional extension period to receive 1 teriflunomide tablet 14 mg daily (or every other day if BW was \<40 kg) until they became adults or until they were able to switch to the commercial product, whichever came first.
|
|---|---|---|---|
|
Double-blind Period (up to Week 96)
STARTED
|
57
|
109
|
0
|
|
Double-blind Period (up to Week 96)
COMPLETED
|
53
|
102
|
0
|
|
Double-blind Period (up to Week 96)
NOT COMPLETED
|
4
|
7
|
0
|
|
Open Label Period (up to Week 192)
STARTED
|
52
|
100
|
0
|
|
Open Label Period (up to Week 192)
COMPLETED
|
31
|
73
|
0
|
|
Open Label Period (up to Week 192)
NOT COMPLETED
|
21
|
27
|
0
|
|
Extension Period (Up to Week 492)
STARTED
|
0
|
0
|
27
|
|
Extension Period (Up to Week 492)
COMPLETED
|
0
|
0
|
24
|
|
Extension Period (Up to Week 492)
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Placebo/Teriflunomide
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in double blind (DB) treatment period. After completion of DB period, eligible participants entered in open label (OL) period and received 1 teriflunomide tablet, 3.5 milligrams (mg) (in case of body weight \[BW\] up to 40 kilograms \[kg\]) or 7 mg (BW greater than \[\>\] 40 kg) for first 8 weeks. After 8 weeks if individual predicted PK parameter was less than or equal to (\<=) 95th percentile of adult range after 7 mg once daily, then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW\>40 kg) in the OL period for additional 96 weeks (i.e., up to Week 192). If individual predicted PK parameters \>95th percentile of adult range then participant received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).The adult range (5th-95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as maximum concentration observed (Cmax) ranging from 8.03 to 49.10 micrograms per milliliter (mcg/mL) and area under the curve from time 0 hour to 24 hours (AUC0-24) ranging from 184 to 1160 micrograms\*hour per milliliter (mcg\*h/mL).
|
Teriflunomide/Teriflunomide
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily, then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL. After completion of DB period, eligible participants entered in OL period and continued receiving teriflunomide at the same dose in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide
Participants who were not adults when they completed the 192-week OL period were offered an optional additional extension period to receive 1 teriflunomide tablet 14 mg daily (or every other day if BW was \<40 kg) until they became adults or until they were able to switch to the commercial product, whichever came first.
|
|---|---|---|---|
|
Double-blind Period (up to Week 96)
Adverse Event
|
0
|
6
|
0
|
|
Double-blind Period (up to Week 96)
Lack of Efficacy
|
2
|
1
|
0
|
|
Double-blind Period (up to Week 96)
Withdrawal by Subject
|
2
|
0
|
0
|
|
Open Label Period (up to Week 192)
Lack of Efficacy
|
10
|
14
|
0
|
|
Open Label Period (up to Week 192)
Poor compliance to protocol
|
0
|
1
|
0
|
|
Open Label Period (up to Week 192)
Other reason
|
4
|
7
|
0
|
|
Open Label Period (up to Week 192)
Adverse Event
|
7
|
5
|
0
|
|
Extension Period (Up to Week 492)
Adverse Event
|
0
|
0
|
2
|
|
Extension Period (Up to Week 492)
Poor compliance to protocol
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Placebo/Teriflunomide
n=57 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB treatment period. After completion of DB period, eligible participants entered in OL period and received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) for first 8 weeks. After 8 weeks if individual predicted PK parameter was \<= 95th percentile of adult range after 7 mg once daily, then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW\>40 kg) in the OL period for additional 96 weeks (i.e., up to Week 192). If individual predicted PK parameters \>95th percentile of adult range then participant received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th-95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL.
|
Teriflunomide/Teriflunomide
n=109 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily, then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL. After completion of DB period, eligible participants entered in OL period and continued receiving teriflunomide at the same dose in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.7 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
14.6 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
14.6 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian/White
|
42 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian/Oriental
|
12 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 96Population: Analysis was performed on Intent-to-treat (ITT) population, which consisted of all randomized participants analyzed according to the treatment allocated by randomization.
Time to first clinical relapse was defined as the duration (in weeks) between randomization and first confirmed clinical relapse. Clinical relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon neurological examination and documented by a standardized, quantified functional system score (FSSs) which included 8 items and items were rated on different scales: brain stem, cerebellar and cerebral functions rated on a scale of 0 to 5; visual, pyramidal, sensory and bowel/bladder rated on a scale of 0 to 6 and ambulation on a scale of 0 to 12, where higher score in each scale indicated worsened neurological function. Confirmed clinical relapse were reviewed and confirmed by an independent Relapse Adjudication Panel (RAP). A participant without confirmed clinical relapse, was considered as clinical relapse free until the end of Week 96.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=57 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=109 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Time to First Confirmed Clinical Relapse
|
39.14 weeks
Interval 0.1 to 98.0
|
75.29 weeks
Interval 0.1 to 98.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 48, 72, 96, 120, 144, 168 and 192Population: Analysis was performed on efficacy population which included all participants enrolled and treated with at least 1 dose of teriflunomide in OL period analyzed according to the treatment group allocated by randomization in the DB period.
Participant was considered free of clinical relapse if the participant had no confirmed clinical relapse before treatment discontinuation/completion in 192 weeks treatment period. Clinical relapses: new/recurrent neurological symptoms not associated with fever/infection, lasted at least 24 hours, and accompanied by new objective neurological findings upon neurological examination and documented by standardized, quantified FSSs which included 8 items: rated on different scales: brain stem, cerebellar and cerebral functions rated on scale of 0 to 5; visual, pyramidal, sensory and bowel/bladder rated on scale of 0 to 6 \& ambulation on scale of 0 to 12, where higher score in each scale indicated worsened neurological function. New/recurrent symptoms occurred less than 30 days following onset of relapse were considered part of same relapse. Probability of participants who were clinical relapse free at specified weeks were estimated by Kaplan-Meier method and reported.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=52 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=100 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Probability of Participants Who Were Clinical Relapse Free at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Week 24
|
0.750 probability of relapse free participants
Interval 0.609 to 0.846
|
0.820 probability of relapse free participants
Interval 0.73 to 0.883
|
—
|
—
|
—
|
—
|
|
Probability of Participants Who Were Clinical Relapse Free at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Week 48
|
0.596 probability of relapse free participants
Interval 0.451 to 0.715
|
0.700 probability of relapse free participants
Interval 0.6 to 0.78
|
—
|
—
|
—
|
—
|
|
Probability of Participants Who Were Clinical Relapse Free at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Week 72
|
0.519 probability of relapse free participants
Interval 0.377 to 0.644
|
0.630 probability of relapse free participants
Interval 0.528 to 0.716
|
—
|
—
|
—
|
—
|
|
Probability of Participants Who Were Clinical Relapse Free at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Week 96
|
0.442 probability of relapse free participants
Interval 0.305 to 0.571
|
0.600 probability of relapse free participants
Interval 0.497 to 0.688
|
—
|
—
|
—
|
—
|
|
Probability of Participants Who Were Clinical Relapse Free at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Week 120
|
0.404 probability of relapse free participants
Interval 0.271 to 0.533
|
0.570 probability of relapse free participants
Interval 0.467 to 0.66
|
—
|
—
|
—
|
—
|
|
Probability of Participants Who Were Clinical Relapse Free at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Week 144
|
0.365 probability of relapse free participants
Interval 0.238 to 0.494
|
0.540 probability of relapse free participants
Interval 0.437 to 0.631
|
—
|
—
|
—
|
—
|
|
Probability of Participants Who Were Clinical Relapse Free at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Week 168
|
0.365 probability of relapse free participants
Interval 0.238 to 0.494
|
0.518 probability of relapse free participants
Interval 0.416 to 0.611
|
—
|
—
|
—
|
—
|
|
Probability of Participants Who Were Clinical Relapse Free at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Week 192
|
0.365 probability of relapse free participants
Interval 0.238 to 0.494
|
0.518 probability of relapse free participants
Interval 0.416 to 0.611
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 192Population: Analysis was performed on efficacy population.
Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during the 192 weeks treatment period divided by the total number of scans performed during 192 weeks. To account for the different numbers of scans performed among the participants, a negative binomial regression model with robust variance estimation was used. The model included the total number of new or enlarged T2-lesions as the response variable, with treatment group, region, pubertal status and age as covariates and log-transformed number of scans as an offset variable.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=52 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=100 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
|
11.087 lesions per scan
Interval 6.586 to 18.662
|
5.664 lesions per scan
Interval 3.417 to 9.389
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 192Population: Analysis was performed on efficacy population.
The number of T1 Gd-Enhancing lesions per scan was defined as the total number of Gd-enhancing lesions that occurred during the 192 weeks treatment period divided by the total number of scans performed during 192 weeks. To account for the different number of scans performed among the participants, a negative binomial regression model with robust variance estimation was used. The model included the total number of T1-lesions as the response variable, with treatment group, region, pubertal status and age as covariates and log-transformed number of scans as an offset variable.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=52 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=100 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Brain Magnetic Resonance Imaging Assessment: Number of T1 Gadolinium (Gd)-Enhancing T1 Lesions Per MRI Scan
|
2.686 lesions per scan
Interval 1.263 to 5.712
|
1.532 lesions per scan
Interval 0.624 to 3.762
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, DB period: Weeks 24, 36, 48, 72 and 96; OL period: Weeks 48, 96, 144 and 192Population: Analysis was performed on efficacy population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Volume of T2 lesions was measured by MRI scan.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=52 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=98 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192
DB Period: Week 24
|
3.0 milliliters
Standard Deviation 7.0
|
0.5 milliliters
Standard Deviation 1.8
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192
DB Period: Week 36
|
4.6 milliliters
Standard Deviation 11.7
|
4.4 milliliters
Standard Deviation 21.3
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192
DB Period: Week 48
|
0.5 milliliters
Standard Deviation 0.6
|
-0.2 milliliters
Standard Deviation 3.4
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192
DB Period: Week 72
|
1.2 milliliters
Standard Deviation 1.6
|
0.1 milliliters
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192
DB Period: Week 96
|
0.9 milliliters
Standard Deviation 1.4
|
0.2 milliliters
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192
OL Period: Week 48
|
3.0 milliliters
Standard Deviation 9.7
|
0.6 milliliters
Standard Deviation 8.8
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192
OL Period: Week 96
|
2.7 milliliters
Standard Deviation 8.1
|
1.9 milliliters
Standard Deviation 4.0
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192
OL Period: Week 144
|
4.7 milliliters
Standard Deviation 10.7
|
0.4 milliliters
Standard Deviation 17.1
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192
OL Period: Week 192
|
0.4 milliliters
Standard Deviation 9.4
|
-3.6 milliliters
Standard Deviation 30.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, DB period: Weeks 24, 36, 48, 72 and 96; OL period: Weeks 48, 96, 144 and 192Population: Analysis was performed on efficacy population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Volume of T1 hypointense lesions was measured by MRI scan.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=52 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=98 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions
DB Period: Week 24
|
0.3 milliliters
Standard Deviation 1.3
|
0.0 milliliters
Standard Deviation 0.7
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions
DB Period: Week 36
|
0.8 milliliters
Standard Deviation 1.8
|
0.2 milliliters
Standard Deviation 0.8
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions
DB Period: Week 48
|
0.2 milliliters
Standard Deviation 0.4
|
0.4 milliliters
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions
DB Period: Week 72
|
0.1 milliliters
Standard Deviation 0.7
|
0.1 milliliters
Standard Deviation 0.6
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions
DB Period: Week 96
|
0.1 milliliters
Standard Deviation 0.6
|
0.1 milliliters
Standard Deviation 0.7
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions
OL Period: Week 48
|
0.7 milliliters
Standard Deviation 1.9
|
0.5 milliliters
Standard Deviation 1.4
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions
OL Period: Week 96
|
1.0 milliliters
Standard Deviation 2.0
|
0.6 milliliters
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions
OL Period: Week 144
|
2.0 milliliters
Standard Deviation 3.0
|
1.9 milliliters
Standard Deviation 3.4
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions
OL Period: Week 192
|
4.0 milliliters
Standard Deviation 5.8
|
2.5 milliliters
Standard Deviation 5.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 192Population: Analysis was performed on efficacy population.
The number of new T1 hypointense lesions were obtained from MRI scans.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=52 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=100 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Brain Magnetic Resonance Imaging Assessment: Number of New T1 Hypointense Lesions Per MRI Scan
|
1561 lesions
|
1910 lesions
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 144 and 192Population: Analysis was performed on efficacy population.
Percentage of participants who were free of new or enlarged T2 lesions at Weeks 24, 48, 72, 96, 144 and 192 were reported.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=52 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=100 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Brain Magnetic Resonance Imaging Assessment: Percentage of Participants Free of New or Enlarged MRI T2-Lesions
Week 144
|
11.5 percentage of participants
|
14.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percentage of Participants Free of New or Enlarged MRI T2-Lesions
Week 24
|
86.5 percentage of participants
|
86.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percentage of Participants Free of New or Enlarged MRI T2-Lesions
Week 48
|
32.7 percentage of participants
|
25.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percentage of Participants Free of New or Enlarged MRI T2-Lesions
Week 72
|
15.4 percentage of participants
|
17.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percentage of Participants Free of New or Enlarged MRI T2-Lesions
Week 96
|
15.4 percentage of participants
|
16.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percentage of Participants Free of New or Enlarged MRI T2-Lesions
Week 192
|
7.7 percentage of participants
|
9.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, DB period: Weeks 24, 36, 48, 72 and 96; OL period: Weeks 48, 96, 144 and 192Population: Analysis was performed on efficacy population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Percent change from baseline in brain volume (assessed using MRI scans of the Brain) at Weeks 24, 36, 48,72, 96, 144 and 192 was reported.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=52 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=97 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Brain Magnetic Resonance Imaging Assessment: Percent Change From Baseline in Brain Volume at Weeks 24, 36, 48, 72, 96, 144 and 192
DB Period: Week 96
|
-0.9 percent change
Standard Deviation 1.3
|
-0.8 percent change
Standard Deviation 1.1
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percent Change From Baseline in Brain Volume at Weeks 24, 36, 48, 72, 96, 144 and 192
OL Period: Week 48
|
-1.4 percent change
Standard Deviation 1.6
|
-1.1 percent change
Standard Deviation 1.3
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percent Change From Baseline in Brain Volume at Weeks 24, 36, 48, 72, 96, 144 and 192
OL Period: Week 96
|
-1.8 percent change
Standard Deviation 1.9
|
-1.4 percent change
Standard Deviation 1.6
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percent Change From Baseline in Brain Volume at Weeks 24, 36, 48, 72, 96, 144 and 192
OL Period: Week 144
|
-3.1 percent change
Standard Deviation 2.8
|
-2.0 percent change
Standard Deviation 1.7
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percent Change From Baseline in Brain Volume at Weeks 24, 36, 48, 72, 96, 144 and 192
OL Period: Week 192
|
-2.2 percent change
Standard Deviation 1.2
|
-3.0 percent change
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percent Change From Baseline in Brain Volume at Weeks 24, 36, 48, 72, 96, 144 and 192
DB Period: Week 24
|
-0.3 percent change
Standard Deviation 0.7
|
-0.2 percent change
Standard Deviation 0.7
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percent Change From Baseline in Brain Volume at Weeks 24, 36, 48, 72, 96, 144 and 192
DB Period: Week 36
|
-0.7 percent change
Standard Deviation 0.7
|
-0.4 percent change
Standard Deviation 1.0
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percent Change From Baseline in Brain Volume at Weeks 24, 36, 48, 72, 96, 144 and 192
DB Period: Week 48
|
-0.6 percent change
Standard Deviation 1.1
|
-0.5 percent change
Standard Deviation 0.9
|
—
|
—
|
—
|
—
|
|
Brain Magnetic Resonance Imaging Assessment: Percent Change From Baseline in Brain Volume at Weeks 24, 36, 48, 72, 96, 144 and 192
DB Period: Week 72
|
-0.9 percent change
Standard Deviation 1.3
|
-0.6 percent change
Standard Deviation 1.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, DB period: Weeks 24, 48, 72 and 96; OL period: Weeks 24, 48, 72, 96, 120, 144, 168 and 192Population: Analysis was performed on efficacy population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
SDMT measures the time to pair abstract symbols with specific numbers. It is a simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The SDMT score is the number of correct substitution and ranged from 0 (worst outcome) to 110 (best outcome), where higher score indicated better cognitive function.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=51 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=96 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
DB Period: Week 24
|
5.1 score on a scale
Standard Deviation 12.0
|
4.6 score on a scale
Standard Deviation 9.1
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
DB Period: Week 48
|
7.3 score on a scale
Standard Deviation 14.1
|
5.7 score on a scale
Standard Deviation 10.3
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
DB Period: Week 72
|
6.4 score on a scale
Standard Deviation 12.9
|
5.6 score on a scale
Standard Deviation 11.5
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
DB Period: Week 96
|
8.8 score on a scale
Standard Deviation 10.7
|
8.1 score on a scale
Standard Deviation 11.1
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 24
|
6.3 score on a scale
Standard Deviation 13.9
|
8.3 score on a scale
Standard Deviation 12.3
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 48
|
6.7 score on a scale
Standard Deviation 13.3
|
7.6 score on a scale
Standard Deviation 13.0
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 72
|
8.0 score on a scale
Standard Deviation 15.5
|
9.2 score on a scale
Standard Deviation 13.0
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 96
|
7.6 score on a scale
Standard Deviation 16.7
|
8.0 score on a scale
Standard Deviation 14.8
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 120
|
3.7 score on a scale
Standard Deviation 15.9
|
7.2 score on a scale
Standard Deviation 10.3
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 144
|
6.6 score on a scale
Standard Deviation 14.4
|
5.2 score on a scale
Standard Deviation 13.0
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 168
|
3.5 score on a scale
Standard Deviation 17.9
|
1.7 score on a scale
Standard Deviation 14.0
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 192
|
12.0 score on a scale
|
-0.3 score on a scale
Standard Deviation 18.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, DB period: Weeks 24, 48, 72 and 96; OL period: Weeks 24, 48, 72, 96, 120, 144, 168 and 192Population: Analysis was performed on efficacy population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
SDMT measures the time to pair abstract symbols with specific numbers. It is a simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The SDMT score is the number of completed items and ranged from 0 (worst outcome) to 110 (best outcome), where higher score indicated better cognitive function.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=51 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=96 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
DB Period: Week 24
|
3.8 score on a scale
Standard Deviation 11.7
|
3.6 score on a scale
Standard Deviation 9.0
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
DB Period: Week 48
|
6.3 score on a scale
Standard Deviation 13.8
|
4.7 score on a scale
Standard Deviation 10.3
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
DB Period: Week 72
|
5.1 score on a scale
Standard Deviation 13.4
|
4.5 score on a scale
Standard Deviation 11.4
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
DB Period: Week 96
|
7.1 score on a scale
Standard Deviation 11.2
|
6.9 score on a scale
Standard Deviation 11.1
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 24
|
4.8 score on a scale
Standard Deviation 13.5
|
7.1 score on a scale
Standard Deviation 12.4
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 48
|
5.5 score on a scale
Standard Deviation 12.8
|
6.4 score on a scale
Standard Deviation 13.0
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 72
|
6.4 score on a scale
Standard Deviation 15.4
|
8.1 score on a scale
Standard Deviation 12.8
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 96
|
6.3 score on a scale
Standard Deviation 16.6
|
7.6 score on a scale
Standard Deviation 12.5
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 120
|
3.7 score on a scale
Standard Deviation 14.7
|
6.3 score on a scale
Standard Deviation 11.5
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 144
|
4.8 score on a scale
Standard Deviation 15.1
|
3.7 score on a scale
Standard Deviation 13.4
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 168
|
2.7 score on a scale
Standard Deviation 15.5
|
-0.3 score on a scale
Standard Deviation 15.6
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
OL Period: Week 192
|
12.0 score on a scale
|
-1.5 score on a scale
Standard Deviation 18.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 96 and 192Population: Analysis was performed on efficacy population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
The BVMT consists of three trials in which participants must recall shapes by drawing figures on a blank page (response booklet) after being given the opportunity to memorize the figures (given in BMVT-R form) for 10 seconds. BMVT-R form consists of six figures. Points are awarded based on the accuracy of the drawn figure and by correct placement on the blank page. A minimum of 0 to 12 points/scores are awarded per trial, so a participant can score between 0 and 36 points for all three trials (by adding the points/score from each trial), where higher score indicates better outcome.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=31 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=69 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Cognitive Assessment: Change From Baseline in Brief Visuospatial Memory Test-Revised (BVMT-R) Scores at Weeks 96 and 192
Baseline
|
23.8 score on a scale
Standard Deviation 7.2
|
24.8 score on a scale
Standard Deviation 6.4
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Brief Visuospatial Memory Test-Revised (BVMT-R) Scores at Weeks 96 and 192
Change at Week 96
|
-0.8 score on a scale
Standard Deviation 9.3
|
1.6 score on a scale
Standard Deviation 5.3
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Brief Visuospatial Memory Test-Revised (BVMT-R) Scores at Weeks 96 and 192
Change at Week 192
|
1.0 score on a scale
Standard Deviation 6.9
|
1.2 score on a scale
Standard Deviation 5.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 96 and 192Population: Analysis was performed on efficacy population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching. The task requires a participant to 'connect-the-dots' of 25 consecutive numbers (1,2, 3, etc.) in sequential order on a sheet of paper or computer screen. The goal of the participant is to finish the test as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). This is a timed test and the number of seconds to complete the task is recorded. Maximum time allowed is 300 seconds. A lower score indicated better cognitive function.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=14 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=29 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Cognitive Assessment: Change From Baseline in Trail Making Test- Part A (TMT-A) Test Scores (in Seconds) at Week 96 and 192
Baseline
|
43.4 seconds
Standard Deviation 24.2
|
47.1 seconds
Standard Deviation 23.7
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Trail Making Test- Part A (TMT-A) Test Scores (in Seconds) at Week 96 and 192
Change at Week 96
|
8.4 seconds
Standard Deviation 9.0
|
-3.1 seconds
Standard Deviation 19.5
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Trail Making Test- Part A (TMT-A) Test Scores (in Seconds) at Week 96 and 192
Change at Week 192
|
6.3 seconds
Standard Deviation 20.7
|
-6.6 seconds
Standard Deviation 17.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 96 and 192Population: Analysis was performed on efficacy population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
TMT-B is a cognitive test that gives a measure of various aspects of cognitive performance. It is used to measure cognitive fatigue. The test consisted of 25 circles containing 13 sequential numbers (1 to 13) and 12 sequential letters (A to L) positioned. The test evaluates the time (in seconds) to correctly order letters and numbers in alternate order (1, A, 2, B etc.). Maximum time allowed is 300 seconds, where less time/lower score indicated better cognitive function/performance.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=14 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=28 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Cognitive Assessment: Change From Baseline in Trail Making Test B (TMT-B) Test Scores (in Seconds) at Weeks 96 and 192
Baseline
|
113.8 seconds
Standard Deviation 81.5
|
115.0 seconds
Standard Deviation 44.6
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Trail Making Test B (TMT-B) Test Scores (in Seconds) at Weeks 96 and 192
Change at Week 96
|
-19.8 seconds
Standard Deviation 33.7
|
-29.5 seconds
Standard Deviation 56.6
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Trail Making Test B (TMT-B) Test Scores (in Seconds) at Weeks 96 and 192
Change at Week 192
|
-37.0 seconds
Standard Deviation 83.3
|
-18.8 seconds
Standard Deviation 37.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 96 and 192Population: Analysis was performed on efficacy population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
The Beery VMI is a non-verbal assessment that assessed the extent to which individuals can integrate their visual and motor abilities. The participants were provided with geometric designs ranging from simple line drawings to more complex figures and were asked to copy the designs. The test consisted of 24 figures. One point was scored for each successful copy of drawings and no scoring was given when the participant failed to copy the drawings properly. Each successful copying of drawings was summed up and the total was scored on a scale ranged from 0 to 24, where higher score indicated better visual construction skills/better visual and motor abilities and lower score indicated poor visual construction skills/poor visual and motor abilities.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=39 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=82 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Cognitive Assessment: Change From Baseline in Beery Visual-motor Integration (BVMI) Scores at Weeks 96 and 192
Baseline
|
26.1 score on a scale
Standard Deviation 5.2
|
25.9 score on a scale
Standard Deviation 4.0
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Beery Visual-motor Integration (BVMI) Scores at Weeks 96 and 192
Change at Week 96
|
0.6 score on a scale
Standard Deviation 2.4
|
-0.4 score on a scale
Standard Deviation 4.8
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Beery Visual-motor Integration (BVMI) Scores at Weeks 96 and 192
Change at Week 192
|
0.1 score on a scale
Standard Deviation 5.4
|
0.4 score on a scale
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 96 and 192Population: Analysis was performed on efficacy population. Here, "overall number of participants analyzed" = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
The WASI-II: Vocabulary test is a quick estimate of an individual's level of intellectual functioning which comprised of 31 total items that required the participant to orally define 3 images and 28 words presented both orally and visually. Items 1 to 3 rated on a score of 0 or 1, items 4 and 5 rated on a score of 0 or 2, items 6 to 31 rated on a scale of 0 to 2. Each item score was summed up to derive the total score which ranged from 0 (minimum score) to 59 (maximum score), where higher score indicated better level of intellectual functioning/higher level of intelligence.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=1 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=3 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Cognitive Assessment: Change From Baseline in Wechsler Abbreviated Scale of Intelligence-II (WASI-II) Vocabulary Total Raw Scores at Weeks 96 and 192
Baseline
|
39.0 score on a scale
|
34.3 score on a scale
Standard Deviation 7.0
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Wechsler Abbreviated Scale of Intelligence-II (WASI-II) Vocabulary Total Raw Scores at Weeks 96 and 192
Change at Week 96
|
5.0 score on a scale
|
4.0 score on a scale
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Wechsler Abbreviated Scale of Intelligence-II (WASI-II) Vocabulary Total Raw Scores at Weeks 96 and 192
Change at Week 192
|
3.0 score on a scale
|
5.0 score on a scale
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 96 and 192Population: Analysis was performed on efficacy population. Here, "overall number of participants analyzed" = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Letter Fluency is a condition measured in the D-KEFS. Participants were asked to name as many words as they can, starting with a specified letter for 60 seconds. The words cannot be names, places, numbers or grammatical variants of previous answers. Repeated answers were not scored as a correct response. There were 3 trials, with 3 different letters. The total number of correct responses was totaled for all 3 trials and a letter fluency score was given. A higher score was considered better. There was no set range as the score depends on how many correct words the participant relays in the given time period.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=2 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=6 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Cognitive Assessment: Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Letter Fluency Total Correct Raw Score at Weeks 96 and 192
Baseline
|
32.5 score on a scale
Standard Deviation 3.5
|
21.0 score on a scale
Standard Deviation 6.0
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Letter Fluency Total Correct Raw Score at Weeks 96 and 192
Change at Week 96
|
-3.0 score on a scale
|
4.0 score on a scale
Standard Deviation 9.9
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Letter Fluency Total Correct Raw Score at Weeks 96 and 192
Change at Week 192
|
5.0 score on a scale
|
-6.5 score on a scale
Standard Deviation 16.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 96 and 192Population: Analysis was performed on efficacy population. Here, "overall number of participants analyzed" = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Category Fluency is a condition measured in the D-KEFS. It measured participant's ability to generate words from three different categories (e.g., fruits, vegetables and animals), within a minute for each category. Total score was number of correct words for each category with no points for repetitions or non-words. Score ranged from 0 to unlimited, where 0 = low score, higher score indicated better performance.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=2 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=6 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Cognitive Assessment: Change From Baseline in Delis-Kaplan Executive Function System Category Fluency Total Correct Raw Score at Weeks 96 and 192
Baseline
|
28.0 score on a scale
Standard Deviation 1.4
|
27.5 score on a scale
Standard Deviation 9.2
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Delis-Kaplan Executive Function System Category Fluency Total Correct Raw Score at Weeks 96 and 192
Change at Week 96
|
6.0 score on a scale
|
5.0 score on a scale
Standard Deviation 5.7
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment: Change From Baseline in Delis-Kaplan Executive Function System Category Fluency Total Correct Raw Score at Weeks 96 and 192
Change at Week 192
|
-2.0 score on a scale
|
-13.5 score on a scale
Standard Deviation 17.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 96 and 192Population: Analysis was performed on efficacy population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
SRT is a test to assess verbal learning and memory. During the administration of the SRT only the examiner and the participant should be in the testing room. A list of twelve words was read aloud by the examiner at a rate of one word per two seconds. The participant is asked to recall all twelve words after a 30 minute delay. Only the words that were missed on the preceding trial were given in the consecutive trial. The total score represented a sum score of total 6 trials, therefore the score range was from 0 to 72. The lower the score the worse the outcome, higher score indicated better recall.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=2 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=4 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
Cognitive Assessment - Selective Reminding Test (SRT): Change From Baseline in Total Number of Words on Delayed Recall at Weeks 96 and 192
Change at Week 96
|
1.0 score on a scale
|
-0.5 score on a scale
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment - Selective Reminding Test (SRT): Change From Baseline in Total Number of Words on Delayed Recall at Weeks 96 and 192
Baseline
|
3.5 score on a scale
Standard Deviation 4.9
|
10.0 score on a scale
Standard Deviation 1.4
|
—
|
—
|
—
|
—
|
|
Cognitive Assessment - Selective Reminding Test (SRT): Change From Baseline in Total Number of Words on Delayed Recall at Weeks 96 and 192
Change at Week 192
|
0.0 score on a scale
|
0.0 score on a scale
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose on Week 36Population: Analysis was performed on PK population which included all randomized participants exposed to DB study medication and had at least 1 PK sample taken. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and "0'' signifies that none of the participant was evaluable for Teriflunomide 3.5 mg arm.
Ctrough was defined as the concentration reached by the drug before the next dose administered. Data for this outcome measure was planned to be collected and analyzed separately for each dose of Teriflunomide. PK samples for teriflunomide 3.5 mg were collected during the first 8 weeks but all participants were switched to teriflunomide 7 mg after Week 8. Hence, plasma concentration of teriflunomide 7 mg and 14 mg were reported.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=10 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
n=66 Participants
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
DB: Pharmacokinetics: Steady-state Trough Concentration (Ctrough) of Teriflunomide
|
—
|
53.1 micrograms per milliliter
Standard Deviation 25.3
|
67.8 micrograms per milliliter
Standard Deviation 41.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 192Population: Analysis was performed on efficacy population.
Time to first clinical relapse was defined as duration (in weeks) after enrollment in OL period and first confirmed clinical relapse. Clinical relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasted at least 24 hours and accompanied by new objective neurological findings upon neurological examination and documented by standardized, quantified FSSs which included 8 items and items were rated on different scales: brain stem, cerebellar \& cerebral functions rated on scale of 0 to 5; visual, pyramidal, sensory and bowel/bladder rated on scale of 0 to 6 and ambulation on scale of 0 to 12 where higher score in each scale indicated worsened neurological function. Confirmed clinical relapse were reviewed and confirmed by independent RAP. Participant without confirmed clinical relapse, was considered as clinical relapse free until end of Week 192.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
n=52 Participants
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=100 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
OL: Time to First Confirmed Clinical Relapse
|
95.86 weeks
Interval 0.6 to 176.0
|
96.00 weeks
Interval 1.0 to 183.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose at Week 36Population: Analysis was performed on PK population which included all randomized participants exposed to study medication, regardless of the amount of treatment administered who had at least one PK sample taken in OL period. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and "0'' signifies that none of the participant was evaluable for Placebo/Teriflunomide 3.5 mg and Teriflunomide/Teriflunomide 3.5 mg arms.
Ctrough was defined as the concentration reached by the drug before the next dose is administered. Data for this outcome measure was planned to be collected and analyzed separately for each dose of teriflunomide. PK samples for teriflunomide 3.5 mg were collected during the first 8 weeks but all participants were switched to teriflunomide 7 mg after Week 8. Hence, plasma concentration of teriflunomide 7 mg and 14 mg were reported.
Outcome measures
| Measure |
Double-Blind Treatment Period: Placebo
Participants received Placebo matching to teriflunomide tablet orally once daily for 96 weeks in DB period.
|
Double-Blind Treatment Period: Teriflunomide
n=12 Participants
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally once daily for 8 weeks. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily: 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if individual predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL in DB period.
|
Teriflunomide 14 mg
n=31 Participants
After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<= 95th percentile of adult range after 7 mg once daily then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 3.5 mg
Participants previously treated with teriflunomide during the DB period received 1 teriflunomide tablet 3.5 mg orally once daily for first 8 weeks of OL period. After 8 weeks, based on individual predicted PK parameters, teriflunomide was administered in following manner up to Week 192: if predicted PK parameters \<= 95th percentile of adult range then participants received 1 tablet of 7 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 14 mg teriflunomide daily (for BW \>40 kg); or if predicted PK parameters \>95th percentile of adult range then participants received 1 tablet of 3.5 mg teriflunomide daily (for BW up to 40 kg) or 1 tablet of 7 mg teriflunomide daily (for BW \>40 kg).
|
Teriflunomide / Teriflunomide 7 mg
n=2 Participants
Participants previously treated with teriflunomide 7 mg during DB period continued receiving teriflunomide 7mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Teriflunomide / Teriflunomide 14 mg
n=79 Participants
Participants previously treated with teriflunomide 14 mg during DB period continued receiving teriflunomide 14mg in the OL period for additional 96 weeks (i.e., up to Week 192).
|
|---|---|---|---|---|---|---|
|
OL: Pharmacokinetics: Steady-state Trough Concentration (Ctrough) of Teriflunomide
|
—
|
45.8 micrograms per milliliter
Standard Deviation 35.3
|
50.4 micrograms per milliliter
Standard Deviation 23.8
|
—
|
33.7 micrograms per milliliter
Standard Deviation 10.7
|
63.6 micrograms per milliliter
Standard Deviation 35.5
|
Adverse Events
Double-Blind Treatment Period: Placebo
Serious events: 6 serious events
Other events: 42 other events
Deaths: 0 deaths
Double-Blind Treatment Period: Teriflunomide
Serious events: 12 serious events
Other events: 89 other events
Deaths: 0 deaths
Open-Label Treatment Period: Placebo/Teriflunomide
Serious events: 15 serious events
Other events: 40 other events
Deaths: 0 deaths
Open-Label Treatment Period: Teriflunomide/Teriflunomide
Serious events: 14 serious events
Other events: 72 other events
Deaths: 0 deaths
Extension Period/Teriflunomide
Serious events: 8 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind Treatment Period: Placebo
n=57 participants at risk
Participants received placebo matching to teriflunomide tablet orally QD for 96 weeks.
|
Double-Blind Treatment Period: Teriflunomide
n=109 participants at risk
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally QD for 8 weeks. After 8 weeks, based on participants predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<=95th percentile of adult range after 7 mg QD: 1 tablet of 7 mg daily (for BW up to 40 kg) or 1 tablet of14 mg daily (for BW\>40 kg); or if predicted PK parameters \>95th percentile of adult range:1 tablet of 3.5 mg daily (for BW up to 40 kg) or 1 tablet of 7 mg daily (for BW\>40 kg). The adult range (5th-95th percentile) of predicted steady state PK parameters for 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL.
|
Open-Label Treatment Period: Placebo/Teriflunomide
n=52 participants at risk
Participants previously treated with placebo during the DB period received 1 teriflunomide tablet 3.5 mg (BW\<=40 kg) or 7 mg teriflunomide (BW \>40 kg) for first 8 weeks. After 8 weeks if predicted PK parameter was \<= 95th percentile of adult range then participants received 7 mg teriflunomide (BW\<=40 kg) and 14 mg teriflunomide (BW\>40 kg) in the OL period for 96 weeks (i.e., up to Week 192). The adult range (5th-95th percentile) of predicted steady state PK parameters for 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL.
|
Open-Label Treatment Period: Teriflunomide/Teriflunomide
n=100 participants at risk
Participants previously treated with teriflunomide during DB period continued receiving teriflunomide in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Extension Period/Teriflunomide
n=27 participants at risk
Participants who were not adults when they completed the 192-week OL period were offered an optional additional extension period to receive 1 teriflunomide tablet 14 mg daily (or every other day if BW \<40 kg) until they became adults or until they were able to switch to the commercial product, whichever came first.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Epilepsy
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Congenital, familial and genetic disorders
Familial Mediterranean Fever
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Ear and labyrinth disorders
Sudden Hearing Loss
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Eye disorders
Diplopia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Anal Fissure
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Pancreatic Disorder
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
General disorders
Asthenia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
General disorders
Gait Disturbance
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
General disorders
Pyrexia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Appendicitis
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Complicated Appendicitis
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Coronavirus Infection
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Encephalitis Viral
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Salpingo-Oophoritis
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Peripheral Nerve Injury
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Transaminases Increased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Headache
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Multiple Sclerosis
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Multiple Sclerosis Pseudo Relapse
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Partial Seizures
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Syncope
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Psychiatric disorders
Adjustment Disorder
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Psychiatric disorders
Affective Disorder
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Psychiatric disorders
Depression Suicidal
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Psychiatric disorders
Somatic Symptom Disorder
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
Other adverse events
| Measure |
Double-Blind Treatment Period: Placebo
n=57 participants at risk
Participants received placebo matching to teriflunomide tablet orally QD for 96 weeks.
|
Double-Blind Treatment Period: Teriflunomide
n=109 participants at risk
Participants received 1 teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW \>40 kg) orally QD for 8 weeks. After 8 weeks, based on participants predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters \<=95th percentile of adult range after 7 mg QD: 1 tablet of 7 mg daily (for BW up to 40 kg) or 1 tablet of14 mg daily (for BW\>40 kg); or if predicted PK parameters \>95th percentile of adult range:1 tablet of 3.5 mg daily (for BW up to 40 kg) or 1 tablet of 7 mg daily (for BW\>40 kg). The adult range (5th-95th percentile) of predicted steady state PK parameters for 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL.
|
Open-Label Treatment Period: Placebo/Teriflunomide
n=52 participants at risk
Participants previously treated with placebo during the DB period received 1 teriflunomide tablet 3.5 mg (BW\<=40 kg) or 7 mg teriflunomide (BW \>40 kg) for first 8 weeks. After 8 weeks if predicted PK parameter was \<= 95th percentile of adult range then participants received 7 mg teriflunomide (BW\<=40 kg) and 14 mg teriflunomide (BW\>40 kg) in the OL period for 96 weeks (i.e., up to Week 192). The adult range (5th-95th percentile) of predicted steady state PK parameters for 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg\*h/mL.
|
Open-Label Treatment Period: Teriflunomide/Teriflunomide
n=100 participants at risk
Participants previously treated with teriflunomide during DB period continued receiving teriflunomide in the OL period for additional 96 weeks (i.e., up to Week 192).
|
Extension Period/Teriflunomide
n=27 participants at risk
Participants who were not adults when they completed the 192-week OL period were offered an optional additional extension period to receive 1 teriflunomide tablet 14 mg daily (or every other day if BW \<40 kg) until they became adults or until they were able to switch to the commercial product, whichever came first.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
6.0%
6/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Ear and labyrinth disorders
Ear Pain
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Endocrine disorders
Autoimmune Thyroiditis
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Eye disorders
Eye Pain
|
7.0%
4/57 • Number of events 8 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
4/109 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Eye disorders
Vision Blurred
|
3.5%
2/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Eye disorders
Visual Impairment
|
3.5%
2/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
10.1%
11/109 • Number of events 13 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
8.0%
8/100 • Number of events 11 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.5%
6/109 • Number of events 9 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
4/57 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
7.3%
8/109 • Number of events 9 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
11.5%
6/52 • Number of events 8 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
7.0%
7/100 • Number of events 9 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
4/57 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
9.2%
10/109 • Number of events 12 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.8%
3/52 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.0%
4/100 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Toothache
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
5/57 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.5%
6/109 • Number of events 7 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
General disorders
Asthenia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
General disorders
Fatigue
|
5.3%
3/57 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
4/109 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
7.7%
4/52 • Number of events 7 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.0%
4/100 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
General disorders
Influenza Like Illness
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
4/109 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
General disorders
Pyrexia
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.6%
5/109 • Number of events 8 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
7.4%
2/27 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Bronchitis
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.6%
5/109 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Covid-19
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
11.1%
3/27 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Cystitis
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Gastroenteritis
|
5.3%
3/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.0%
5/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Influenza
|
7.0%
4/57 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
9.2%
10/109 • Number of events 16 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
9.6%
5/52 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.0%
5/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
7.4%
2/27 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
5/57 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
25.7%
28/109 • Number of events 50 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
15.4%
8/52 • Number of events 13 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
20.0%
20/100 • Number of events 37 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
14.8%
4/27 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Paronychia
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Pharyngitis
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
6.4%
7/109 • Number of events 8 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.0%
4/100 • Number of events 8 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Pulpitis Dental
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Respiratory Tract Infection
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.0%
5/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
4/109 • Number of events 7 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Rhinitis
|
3.5%
2/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
4/109 • Number of events 8 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
6.0%
6/100 • Number of events 7 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Root Canal Infection
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Sinusitis
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
4/109 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Tinea Versicolour
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Tonsillitis
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
4/109 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.0%
4/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Tracheobronchitis
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.5%
6/57 • Number of events 23 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
22.0%
24/109 • Number of events 66 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
13.5%
7/52 • Number of events 32 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
22.0%
22/100 • Number of events 59 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
22.2%
6/27 • Number of events 12 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Infections and infestations
Urinary Tract Infection
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.0%
5/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
7.0%
4/57 • Number of events 7 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.6%
5/109 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
10.0%
10/100 • Number of events 12 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
11.1%
3/27 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
4/109 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Fall
|
7.0%
4/57 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.5%
6/109 • Number of events 8 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Alanine Aminotransferase Increased
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
11.5%
6/52 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
7.4%
2/27 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Blood Albumin Increased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
4/109 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
7.4%
2/27 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Blood Uric Acid Decreased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Electrocardiogram St-T Segment Abnormal
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Glomerular Filtration Rate Increased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Haematocrit Decreased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Monocyte Count Decreased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Monocyte Percentage Increased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
11.1%
3/27 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Neutrophil Percentage Decreased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Neutrophil/Lymphocyte Ratio Decreased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Protein Urine Present
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
4/109 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Weight Decreased
|
5.3%
3/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.5%
6/109 • Number of events 7 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
Weight Increased
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
White Blood Cell Count Decreased
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.6%
5/109 • Number of events 8 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.0%
5/100 • Number of events 9 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
11.1%
3/27 • Number of events 7 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Investigations
White Blood Cells Urine Positive
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.0%
4/100 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
3/57 • Number of events 7 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.6%
5/109 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.5%
2/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.6%
5/109 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.8%
3/52 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Disturbance In Attention
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Dizziness
|
7.0%
4/57 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
8.3%
9/109 • Number of events 9 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
11.5%
6/52 • Number of events 12 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Headache
|
22.8%
13/57 • Number of events 18 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
16.5%
18/109 • Number of events 30 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
13.5%
7/52 • Number of events 22 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
14.0%
14/100 • Number of events 28 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
3/57 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.5%
6/109 • Number of events 7 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.8%
3/52 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Paraesthesia
|
3.5%
2/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
10.1%
11/109 • Number of events 19 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.0%
4/100 • Number of events 7 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Syncope
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
5.8%
3/52 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Nervous system disorders
Tremor
|
3.5%
2/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Psychiatric disorders
Anxiety
|
5.3%
3/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
4/109 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Psychiatric disorders
Depression
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
7.7%
4/52 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Psychiatric disorders
Insomnia
|
5.3%
3/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Psychiatric disorders
Mixed Anxiety And Depressive Disorder
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Renal and urinary disorders
Micturition Urgency
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
9.6%
5/52 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.3%
3/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Reproductive system and breast disorders
Menstrual Disorder
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
3/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.6%
5/109 • Number of events 6 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.8%
2/109 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
6.4%
7/109 • Number of events 8 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
7.0%
7/100 • Number of events 9 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.8%
3/109 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.9%
1/52 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.0%
4/57 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.6%
5/109 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
4.0%
4/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.3%
7/57 • Number of events 7 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
22.0%
24/109 • Number of events 26 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
17.3%
9/52 • Number of events 10 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
10.0%
10/100 • Number of events 10 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/100 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.92%
1/109 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.0%
3/100 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.5%
2/57 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
4/109 • Number of events 4 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.8%
2/52 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 2 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Vascular disorders
Hypertension
|
1.8%
1/57 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
2.0%
2/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
|
Vascular disorders
Orthostatic Hypotension
|
3.5%
2/57 • Number of events 3 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/109 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs and deaths were collected from first dose of study drug (Day 1) up to 96 weeks (for DB period arms), first dose of study drug in OL period (Week 97) up to Week 192 (for OL period arms) and first dose of study drug in extension period (Week 193) up to Week 492 (for extension period arm).
Safety population included all randomized participants exposed to study medication, regardless of the amount of treatment administered.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER