Trial Outcomes & Findings for Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis (NCT NCT00803049)
NCT ID: NCT00803049
Last Updated: 2017-01-30
Results Overview
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period which was defined as the period from the time of first dose of study drug (in LTS6050) up to 4 weeks (28 days) after last dose of study drug. Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included both serious and non-serious AEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
742 participants
Primary outcome timeframe
Baseline (LTS6050) up to 28 days after last dose of study drug up to 450 weeks
Results posted on
2017-01-30
Participant Flow
The study was conducted at 117 centres in 21 countries between 16 October 2006 and 23 December 2015. A total of 742 participants who completed study EFC6049 (NCT00134563), entered in this extension study (LTS6050 \[NCT00803049\]).
Participants who received placebo in EFC6049 study were randomized in 1:1 ratio to receive either teriflunomide 7 mg/day or 14 mg/day and, those who received teriflunomide 7 mg/day or 14 mg/day in EFC6049 (NCT00134563) received same double-blind treatment in this extension study.
Participant milestones
| Measure |
Placebo/Teriflunomide 7 mg
Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
|
Teriflunomide 7 mg/7 mg
Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
|
Placebo/Teriflunomide 14 mg
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
Teriflunomide 14 mg/14 mg
Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
129
|
252
|
108
|
253
|
|
Overall Study
Treated
|
129
|
252
|
108
|
251
|
|
Overall Study
Safety Population
|
129
|
254
|
107
|
250
|
|
Overall Study
COMPLETED
|
68
|
134
|
64
|
151
|
|
Overall Study
NOT COMPLETED
|
61
|
118
|
44
|
102
|
Reasons for withdrawal
| Measure |
Placebo/Teriflunomide 7 mg
Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
|
Teriflunomide 7 mg/7 mg
Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
|
Placebo/Teriflunomide 14 mg
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
Teriflunomide 14 mg/14 mg
Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
21
|
33
|
13
|
27
|
|
Overall Study
Lack of Efficacy
|
10
|
19
|
6
|
13
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
3
|
|
Overall Study
Death
|
2
|
1
|
0
|
2
|
|
Overall Study
Progressive Disease
|
6
|
10
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
19
|
43
|
16
|
44
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
0
|
|
Overall Study
Randomized and Not Treated
|
0
|
0
|
0
|
2
|
|
Overall Study
Other than Specified Above
|
3
|
9
|
2
|
5
|
Baseline Characteristics
Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Placebo/Teriflunomide 7 mg
n=129 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
|
Teriflunomide 7 mg/7 mg
n=252 Participants
Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
|
Placebo/Teriflunomide 14 mg
n=108 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
Teriflunomide 14 mg/14 mg
n=253 Participants
Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
Total
n=742 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
37.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
38.4 years
STANDARD_DEVIATION 8.6 • n=21 Participants
|
|
Gender
Female
|
94 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
536 Participants
n=21 Participants
|
|
Gender
Male
|
35 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
206 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (LTS6050) up to 28 days after last dose of study drug up to 450 weeksPopulation: Safety population: all participants randomized in the LTS6050 study and exposed to IMP during the LTS6050 study treatment period, regardless of the amount of treatment administered. The safety analysis was conducted as the treatment received.
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period which was defined as the period from the time of first dose of study drug (in LTS6050) up to 4 weeks (28 days) after last dose of study drug. Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included both serious and non-serious AEs.
Outcome measures
| Measure |
Placebo/Teriflunomide 7 mg
n=129 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
|
Teriflunomide 7 mg/7 mg
n=254 Participants
Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
|
Placebo/Teriflunomide 14 mg
n=107 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
Teriflunomide 14 mg/14 mg
n=250 Participants
Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE
|
93.8 percentage of participants
|
91.3 percentage of participants
|
94.4 percentage of participants
|
91.2 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any Treatment Emergent SAE
|
24.8 percentage of participants
|
28.0 percentage of participants
|
21.5 percentage of participants
|
24.8 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE Leading to Death
|
2.3 percentage of participants
|
0.8 percentage of participants
|
0 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE Leading to Permanent Discontinuation
|
17.1 percentage of participants
|
12.2 percentage of participants
|
12.1 percentage of participants
|
10.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)Population: Intent-to-treat (ITT) (EFC6049+ LTS6050) population: all participants randomized in both EFC6049 and LTS6050 studies that had at least 1-day IMP exposure during both EFC6049 and LTS6050 studies. Analysis for this outcome measure was performed on the combined data of EFC6049 andLTS6050 study, as pre-specified in the protocol.
Sustained DP defined as sustained increase of at least 1 point from baseline (EFC6049) expanded disability status scale (EDSS) score (0.5 point for participants with baseline EDSS\>5.5) persisting for at least 12 weeks. EDSS: an ordinal scale qualifies disability in participants with MS. EDSS total score range: 0 (normal neurological examination) to 10 (death due to Multiple Sclerosis \[MS\]). Probability of DP at 12 weeks was estimated using Kaplan-Meier method on time to DP defined as date of first DP minus (-) date of randomization in EFC6049 study +1 day. Participants free of DP (no DP observed on treatment) were censored at the date of last on-treatment EDSS evaluation in LTS6050. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.
Outcome measures
| Measure |
Placebo/Teriflunomide 7 mg
n=129 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
|
Teriflunomide 7 mg/7 mg
n=252 Participants
Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
|
Placebo/Teriflunomide 14 mg
n=108 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
Teriflunomide 14 mg/14 mg
n=251 Participants
Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
|---|---|---|---|---|
|
Time to 12 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP
|
0.544 Probability
Interval 0.441 to 0.646
|
0.494 Probability
Interval 0.423 to 0.565
|
0.627 Probability
Interval 0.444 to 0.811
|
0.473 Probability
Interval 0.403 to 0.543
|
SECONDARY outcome
Timeframe: Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)Population: Intent-to-treat (ITT) (EFC6049+ LTS6050) population: all participants randomized in both EFC6049 and LTS6050 studies that had at least 1-day IMP exposure during both EFC6049 and LTS6050 studies. Analysis for this outcome measure was performed on the combined data of EFC6049 andLTS6050 study, as pre-specified in the protocol.
Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS\>5.5) persisting for at least 24 weeks. EDSS: an ordinal scale qualifies disability in participants with MS. EDSS total score range: 0 (normal neurological examination) to 10 (death due to MS). Probability of DP at 24 weeks was estimated using Kaplan-Meier method on time to DP defined as date of first DP minus (-) date of randomization in EFC6049 study +1 day. Participants free of DP (no DP observed on treatment) were censored at the date of last on-treatment EDSS evaluation in LTS6050. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.
Outcome measures
| Measure |
Placebo/Teriflunomide 7 mg
n=129 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
|
Teriflunomide 7 mg/7 mg
n=252 Participants
Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
|
Placebo/Teriflunomide 14 mg
n=108 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
Teriflunomide 14 mg/14 mg
n=251 Participants
Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
|---|---|---|---|---|
|
Time to 24 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP
|
0.444 Probability
Interval 0.338 to 0.55
|
0.434 Probability
Interval 0.363 to 0.504
|
0.518 Probability
Interval 0.411 to 0.624
|
0.438 Probability
Interval 0.367 to 0.509
|
SECONDARY outcome
Timeframe: Up to 10.8 years since EFC6049 randomization (EFC6049: 108 weeks + LTS6050: 450 weeks)Population: Intent-to-treat (ITT) (EFC6049 \[NCT00134563\] + LTS6050) population.
Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS\>5.5) persisting for at least 12 weeks and 24 weeks. EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicates worse neurological function. Percentage of participants who were considered as free of disability progression confirmed after 12 week sustained progression and 24 week sustained progression were reported. Analysis for this outcome measure was performed on combined data of EFC6049 and LTS6050 study, as pre-specified in protocol.
Outcome measures
| Measure |
Placebo/Teriflunomide 7 mg
n=129 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
|
Teriflunomide 7 mg/7 mg
n=252 Participants
Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
|
Placebo/Teriflunomide 14 mg
n=108 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
Teriflunomide 14 mg/14 mg
n=251 Participants
Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
|---|---|---|---|---|
|
Percentage of Participants Free of Sustained Disability Progression (DP)
Free of DP Sustained for 12 Weeks
|
45.6 percentage of participants
|
50.6 percentage of participants
|
37.3 percentage of participants
|
52.7 percentage of participants
|
|
Percentage of Participants Free of Sustained Disability Progression (DP)
Free of DP Sustained for 24 Weeks
|
55.6 percentage of participants
|
56.6 percentage of participants
|
48.2 percentage of participants
|
56.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 8 years since LTS6050 randomizationPopulation: ITT(LTS6050) population: all participants who were randomized in the LTS6050 study and had at least 1-day IMP exposure during the LTS6050 study.
ARR was obtained from total number of confirmed relapses that occurred during treatment period divided by sum of treatment durations in LTS6050 study only. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever was to be confirmed by an increase in EDSS score or Functional System (FS) scores. EDSS: an ordinal scale qualifies disability. EDSS total score range: 0 (normal neurological examination) to 10 (death due to MS). FSS: to assess the neurological function. Total score range: 0 (normal) - 6(worse), higher scores = worse neurological function. To account for the different treatment duration among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log transformed treatment duration as "offset" variable; treatment group, region of enrolment and baseline EDSS stratum as covariates).
Outcome measures
| Measure |
Placebo/Teriflunomide 7 mg
n=129 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
|
Teriflunomide 7 mg/7 mg
n=252 Participants
Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
|
Placebo/Teriflunomide 14 mg
n=108 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
Teriflunomide 14 mg/14 mg
n=251 Participants
Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
|---|---|---|---|---|
|
Annualized MS Relapse Rate (ARR): Poisson Regression Estimates
|
0.216 relapses per participant-year
Interval 0.162 to 0.288
|
0.183 relapses per participant-year
Interval 0.149 to 0.225
|
0.176 relapses per participant-year
Interval 0.132 to 0.236
|
0.160 relapses per participant-year
Interval 0.129 to 0.198
|
SECONDARY outcome
Timeframe: Baseline, Week 192Population: ITT (LTS6050 population). Number of participants analyzed=participants with available data for this outcome measure.
BOD was assessed by cerebral MRI and defined as the total volume of all abnormal brain tissue (calculated as the sum of the total volume of T2-lesion component and T1-hypointense lesion component).
Outcome measures
| Measure |
Placebo/Teriflunomide 7 mg
n=49 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
|
Teriflunomide 7 mg/7 mg
n=99 Participants
Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
|
Placebo/Teriflunomide 14 mg
n=36 Participants
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
Teriflunomide 14 mg/14 mg
n=103 Participants
Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
|
|---|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Volume of Abnormal Lesions (Burden of Disease [BOD]) at Week 192 Since LTS6050 Randomization
|
5.307 millilitres (ml)
Standard Deviation 9.088
|
3.969 millilitres (ml)
Standard Deviation 11.135
|
3.720 millilitres (ml)
Standard Deviation 6.696
|
3.943 millilitres (ml)
Standard Deviation 9.685
|
Adverse Events
Placebo/Teriflunomide 7 mg
Serious events: 32 serious events
Other events: 107 other events
Deaths: 0 deaths
Teriflunomide 7 mg/7 mg
Serious events: 71 serious events
Other events: 195 other events
Deaths: 0 deaths
Placebo/Teriflunomide 14 mg
Serious events: 23 serious events
Other events: 95 other events
Deaths: 0 deaths
Teriflunomide 14 mg/14 mg
Serious events: 62 serious events
Other events: 197 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Teriflunomide 7 mg
n=129 participants at risk
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
|
Teriflunomide 7 mg/7 mg
n=254 participants at risk
Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
Included 2 participants randomized in placebo and teriflunomide 14 mg arm respectively in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participants received correct dose of teriflunomide 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis.
|
Placebo/Teriflunomide 14 mg
n=107 participants at risk
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
Excluded 1 participant randomized in placebo arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received 14 mg dose but included in teriflunomide 7 mg/7 mg arm for safety analysis.
|
Teriflunomide 14 mg/14 mg
n=250 participants at risk
Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
Excluded 1 participant randomized in 14 mg arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received correct dose of 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis.
|
|---|---|---|---|---|
|
Nervous system disorders
Sciatica
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.80%
2/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.80%
2/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.79%
2/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Cellulitis
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Endometritis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.79%
2/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Sepsis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Bone abscess
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Diverticulitis
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.79%
2/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Pyelonephritis
|
1.6%
2/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Tooth abscess
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Wound infection
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
1.9%
2/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.79%
2/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.80%
2/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Psychiatric disorders
Depression
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Psychiatric disorders
Suicide attempt
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Psychiatric disorders
Affective disorder
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Epilepsy
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Headache
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Seizure
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Uhthoff's phenomenon
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Facial neuralgia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Eye disorders
Uveitis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
1.2%
3/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Cardiac disorders
Cardiac arrest
|
1.6%
2/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Cardiac disorders
Cardiac valve disease
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Vascular disorders
Venous stenosis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
1.2%
3/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.80%
2/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.79%
2/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.80%
2/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Gastroduodenal haemorrhage
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Mesenteric haematoma
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Mouth swelling
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.80%
2/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.6%
2/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.0%
5/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.80%
2/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Renal and urinary disorders
Urinary retention
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.80%
2/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.79%
2/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Reproductive system and breast disorders
Premenstrual cramps
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Congenital, familial and genetic disorders
Dolichocolon
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
General disorders
Pyrexia
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.80%
2/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
General disorders
Chest pain
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
General disorders
Death
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
General disorders
General physical health deterioration
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
General disorders
Sudden death
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
4/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
1.2%
3/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.8%
3/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.4%
6/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.80%
2/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Investigations
Transaminases increased
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Investigations
Blood pressure increased
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Investigations
Lipase increased
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.80%
2/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.79%
2/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Hepatic rupture
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Traumatic shock
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Surgical and medical procedures
Mammoplasty
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.40%
1/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Surgical and medical procedures
Osteotomy
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Social circumstances
Miscarriage of partner
|
0.00%
0/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.39%
1/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.00%
0/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
Other adverse events
| Measure |
Placebo/Teriflunomide 7 mg
n=129 participants at risk
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
|
Teriflunomide 7 mg/7 mg
n=254 participants at risk
Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
Included 2 participants randomized in placebo and teriflunomide 14 mg arm respectively in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participants received correct dose of teriflunomide 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis.
|
Placebo/Teriflunomide 14 mg
n=107 participants at risk
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
Excluded 1 participant randomized in placebo arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received 14 mg dose but included in teriflunomide 7 mg/7 mg arm for safety analysis.
|
Teriflunomide 14 mg/14 mg
n=250 participants at risk
Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
Excluded 1 participant randomized in 14 mg arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received correct dose of 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
26.4%
34/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
28.0%
71/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
27.1%
29/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
32.4%
81/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Influenza
|
14.7%
19/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
15.4%
39/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
18.7%
20/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
14.8%
37/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Urinary tract infection
|
15.5%
20/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
12.2%
31/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
17.8%
19/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
14.4%
36/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Sinusitis
|
5.4%
7/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.3%
16/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
4.7%
5/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
11.2%
28/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.6%
15/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
11.4%
29/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
14.0%
15/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
11.2%
28/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Bronchitis
|
7.8%
10/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.7%
17/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
8.4%
9/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
10.4%
26/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Gastroenteritis
|
6.2%
8/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.9%
10/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
7.5%
8/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.6%
14/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Cystitis
|
7.0%
9/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.1%
8/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.7%
4/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.6%
9/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
6.2%
8/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.9%
10/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
8.4%
9/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.8%
7/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Infections and infestations
Oral herpes
|
2.3%
3/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.7%
17/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.6%
6/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.4%
6/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.8%
7/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
8.4%
9/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
4.8%
12/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.6%
2/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.4%
6/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.6%
6/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.4%
6/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Psychiatric disorders
Insomnia
|
4.7%
6/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.9%
15/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
7.5%
8/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.8%
17/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Psychiatric disorders
Depression
|
7.8%
10/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
9.4%
24/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
10.3%
11/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.0%
15/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Psychiatric disorders
Anxiety
|
2.3%
3/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.4%
6/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.6%
6/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.2%
8/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Headache
|
16.3%
21/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
16.5%
42/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
16.8%
18/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
16.8%
42/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Paraesthesia
|
4.7%
6/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
10.2%
26/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
12.1%
13/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
9.2%
23/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Dizziness
|
3.9%
5/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.5%
14/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.5%
7/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.6%
14/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Nervous system disorders
Hypoaesthesia
|
3.1%
4/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
7.9%
20/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
9.3%
10/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.2%
13/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Vascular disorders
Hypertension
|
7.8%
10/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
8.7%
22/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
10.3%
11/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
14.8%
37/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.9%
14/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
8.7%
22/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.5%
7/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
7.6%
19/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.4%
16/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
9.4%
24/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
17.8%
19/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
12.0%
30/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Nausea
|
7.8%
10/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
7.9%
20/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
9.3%
10/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
11.6%
29/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Constipation
|
3.1%
4/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.9%
10/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.5%
7/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.0%
15/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
3/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.3%
16/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.7%
4/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
4.0%
10/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
5/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
8.7%
22/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
7.5%
8/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.6%
9/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Toothache
|
1.6%
2/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.1%
13/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.8%
3/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.6%
9/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
8/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.1%
8/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
4.7%
5/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.2%
8/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.6%
2/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.8%
7/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.0%
15/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.7%
6/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
4.3%
11/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.6%
6/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.6%
14/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.5%
11/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
4.7%
12/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
16.8%
18/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.4%
6/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
10/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
14.6%
37/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
15.0%
16/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
16.0%
40/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.9%
14/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
10.6%
27/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
18.7%
20/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
12.8%
32/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.2%
17/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
12.2%
31/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
8.4%
9/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
11.2%
28/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
4.3%
11/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.4%
16/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.7%
6/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
4.7%
12/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.7%
4/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.2%
13/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Renal and urinary disorders
Micturition urgency
|
6.2%
8/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
1.6%
4/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.8%
3/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.6%
9/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
General disorders
Fatigue
|
13.2%
17/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
14.6%
37/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
15.9%
17/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
10.4%
26/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
General disorders
Influenza like illness
|
0.78%
1/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.4%
6/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
0.93%
1/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
5.2%
13/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
14.0%
18/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
14.2%
36/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
16.8%
18/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
12.8%
32/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.1%
4/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
6.3%
16/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
1.9%
2/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
4.8%
12/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
4/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
7.1%
18/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.7%
4/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
4.4%
11/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Investigations
Blood pressure increased
|
6.2%
8/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.9%
10/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
4.7%
5/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.8%
7/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
7.0%
9/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
7.9%
20/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
7.5%
8/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
13.6%
34/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.1%
4/129 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
2.0%
5/254 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
7.5%
8/107 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
|
3.2%
8/250 • All AEs were collected from signature of informed consent form up to 28 days after the last dose of study drug up to Week 450, regardless of seriousness or relationship to investigational product
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (the time from the first dose of study treatment up to 4 weeks \[28 days\] after the last dose of study treatment). Analysis was performed on safety population and was conducted as per the treatment received.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER