Trial Outcomes & Findings for Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis (NCT NCT00134563)
NCT ID: NCT00134563
Last Updated: 2013-01-04
Results Overview
ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations. 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 scores. To account for the different treatment durations 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 enrollment and baseline EDSS stratum as covariates).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1088 participants
Primary outcome timeframe
108 weeks
Results posted on
2013-01-04
Participant Flow
The recruitment initiated in September 2004 was completed in February 2008. A total of 1338 patients were screened at 127 sites in 21 countries.
Randomization was stratified by country and baseline disability (Expanded Disability Status Scale \[EDSS\] score ≤3.5 or \>3.5). Assignment to groups was done centrally using an Interactive Voice Response System (IVRS\] in a 1:1:1 ratio after confirmation of the selection criteria. 1088 participants were randomized.
Participant milestones
| Measure |
Placebo
Placebo (for teriflunomide) once daily for 108 weeks
|
Teriflunomide 7 mg
Teriflunomide 7 mg once daily for 108 weeks
|
Teriflunomide 14 mg
Teriflunomide 14 mg once daily for 108 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
363
|
366
|
359
|
|
Overall Study
Treated
|
363
|
365
|
358
|
|
Overall Study
COMPLETED
|
259
|
274
|
263
|
|
Overall Study
NOT COMPLETED
|
104
|
92
|
96
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (for teriflunomide) once daily for 108 weeks
|
Teriflunomide 7 mg
Teriflunomide 7 mg once daily for 108 weeks
|
Teriflunomide 14 mg
Teriflunomide 14 mg once daily for 108 weeks
|
|---|---|---|---|
|
Overall Study
Not treated due to protocol violation
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
29
|
37
|
38
|
|
Overall Study
Lack of Efficacy
|
24
|
14
|
17
|
|
Overall Study
Protocol Violation
|
3
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
2
|
|
Overall Study
progressive disease
|
11
|
4
|
2
|
|
Overall Study
did not wish to continue
|
33
|
32
|
26
|
|
Overall Study
Reason other than above
|
0
|
2
|
5
|
Baseline Characteristics
Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Placebo
n=363 Participants
Placebo (for teriflunomide) once daily for 108 weeks
|
Teriflunomide 7 mg
n=365 Participants
Teriflunomide 7 mg once daily for 108 weeks
|
Teriflunomide 14 mg
n=358 Participants
Teriflunomide 14 mg once daily for 108 weeks
|
Total
n=1086 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
38.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
37.8 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
37.9 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
275 Participants
n=5 Participants
|
254 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
783 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
303 Participants
n=4 Participants
|
|
Region of enrollment
America
|
82 participants
n=5 Participants
|
83 participants
n=7 Participants
|
80 participants
n=5 Participants
|
245 participants
n=4 Participants
|
|
Region of enrollment
Eastern Europe
|
114 participants
n=5 Participants
|
116 participants
n=7 Participants
|
108 participants
n=5 Participants
|
338 participants
n=4 Participants
|
|
Region of enrollment
Western Europe
|
167 participants
n=5 Participants
|
166 participants
n=7 Participants
|
170 participants
n=5 Participants
|
503 participants
n=4 Participants
|
|
Time since first diagnosis of multiple sclerosis (MS)
|
5.13 Years
STANDARD_DEVIATION 5.59 • n=5 Participants
|
5.29 Years
STANDARD_DEVIATION 5.36 • n=7 Participants
|
5.59 Years
STANDARD_DEVIATION 5.44 • n=5 Participants
|
5.33 Years
STANDARD_DEVIATION 5.48 • n=4 Participants
|
|
Number of MS relapses
Within the past year
|
1 MS relapses
n=5 Participants
|
1 MS relapses
n=7 Participants
|
1 MS relapses
n=5 Participants
|
1 MS relapses
n=4 Participants
|
|
Number of MS relapses
Within the past 2 years
|
2 MS relapses
n=5 Participants
|
2 MS relapses
n=7 Participants
|
2 MS relapses
n=5 Participants
|
2 MS relapses
n=4 Participants
|
|
Time since most recent MS relapse onset
|
6.28 months
STANDARD_DEVIATION 3.62 • n=5 Participants
|
6.29 months
STANDARD_DEVIATION 3.29 • n=7 Participants
|
6.50 months
STANDARD_DEVIATION 3.71 • n=5 Participants
|
6.35 months
STANDARD_DEVIATION 3.54 • n=4 Participants
|
|
MS subtype
Relapsing Remitting
|
329 participants
n=5 Participants
|
332 participants
n=7 Participants
|
332 participants
n=5 Participants
|
993 participants
n=4 Participants
|
|
MS subtype
Secondary Progressive
|
22 participants
n=5 Participants
|
17 participants
n=7 Participants
|
12 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
MS subtype
Progressive Relapsing
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
14 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
MS medication in the past 2 years
Yes
|
90 participants
n=5 Participants
|
102 participants
n=7 Participants
|
102 participants
n=5 Participants
|
294 participants
n=4 Participants
|
|
MS medication in the past 2 years
No
|
273 participants
n=5 Participants
|
263 participants
n=7 Participants
|
256 participants
n=5 Participants
|
792 participants
n=4 Participants
|
|
Baseline EDSS total score
≤ 3.5
|
281 participants
n=5 Participants
|
280 participants
n=7 Participants
|
276 participants
n=5 Participants
|
837 participants
n=4 Participants
|
|
Baseline EDSS total score
> 3.5
|
82 participants
n=5 Participants
|
85 participants
n=7 Participants
|
82 participants
n=5 Participants
|
249 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 108 weeksPopulation: All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).
ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations. 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 scores. To account for the different treatment durations 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 enrollment and baseline EDSS stratum as covariates).
Outcome measures
| Measure |
Placebo
n=363 Participants
Placebo (for teriflunomide) once daily for 108 weeks
|
Teriflunomide 7 mg
n=365 Participants
Teriflunomide 7 mg once daily for 108 weeks
|
Teriflunomide 14 mg
n=358 Participants
Teriflunomide 14 mg once daily for 108 weeks
|
|---|---|---|---|
|
Annualized Relapse Rate [ARR]: Poisson Regression Estimates
|
0.539 relapses per year
Interval 0.466 to 0.623
|
0.370 relapses per year
Interval 0.318 to 0.432
|
0.369 relapses per year
Interval 0.308 to 0.441
|
SECONDARY outcome
Timeframe: 108 weeksPopulation: All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).
12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score \>5.5) that persisted for at least 12 weeks. Probability of disability progression at 24, 48 and 108 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation. 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. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t.
Outcome measures
| Measure |
Placebo
n=363 Participants
Placebo (for teriflunomide) once daily for 108 weeks
|
Teriflunomide 7 mg
n=365 Participants
Teriflunomide 7 mg once daily for 108 weeks
|
Teriflunomide 14 mg
n=358 Participants
Teriflunomide 14 mg once daily for 108 weeks
|
|---|---|---|---|
|
Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints
Probability of disability progression at 108 weeks
|
27.3 percent probability
Interval 22.3 to 32.3
|
21.7 percent probability
Interval 17.1 to 26.3
|
20.2 percent probability
Interval 15.6 to 24.7
|
|
Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints
Probability of disability progression at 24 weeks
|
8.6 percent probability
Interval 5.7 to 11.6
|
5.8 percent probability
Interval 3.3 to 8.3
|
6.2 percent probability
Interval 3.6 to 8.8
|
|
Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints
Probability of disability progression at 48 weeks
|
16.0 percent probability
Interval 12.1 to 20.0
|
13.1 percent probability
Interval 9.4 to 16.7
|
11.3 percent probability
Interval 7.9 to 14.8
|
SECONDARY outcome
Timeframe: baseline (before randomization) and 108 weeksPopulation: All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).
Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.
Outcome measures
| Measure |
Placebo
n=363 Participants
Placebo (for teriflunomide) once daily for 108 weeks
|
Teriflunomide 7 mg
n=365 Participants
Teriflunomide 7 mg once daily for 108 weeks
|
Teriflunomide 14 mg
n=358 Participants
Teriflunomide 14 mg once daily for 108 weeks
|
|---|---|---|---|
|
Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)
Change in total lesion volume
|
2.208 mililiters (mL)
Standard Deviation 7.002
|
1.308 mililiters (mL)
Standard Deviation 6.799
|
0.723 mililiters (mL)
Standard Deviation 7.591
|
|
Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)
- Change in T1-hypointense lesion component
|
0.533 mililiters (mL)
Standard Deviation 1.063
|
0.499 mililiters (mL)
Standard Deviation 1.154
|
0.331 mililiters (mL)
Standard Deviation 1.012
|
|
Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)
- Change in T2-lesion component
|
1.674 mililiters (mL)
Standard Deviation 6.473
|
0.810 mililiters (mL)
Standard Deviation 6.181
|
0.392 mililiters (mL)
Standard Deviation 6.901
|
SECONDARY outcome
Timeframe: baseline (before randomization) and 108 weeksPopulation: All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).
FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Least-square means were estimated using a Mixed-effect model with repeated measures \[MMRM\] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors).
Outcome measures
| Measure |
Placebo
n=363 Participants
Placebo (for teriflunomide) once daily for 108 weeks
|
Teriflunomide 7 mg
n=365 Participants
Teriflunomide 7 mg once daily for 108 weeks
|
Teriflunomide 14 mg
n=358 Participants
Teriflunomide 14 mg once daily for 108 weeks
|
|---|---|---|---|
|
Changes From Baseline in Fatigue Impact Scale [FIS] Total Score
|
4.300 units on a scale
Standard Error 1.670 • Interval -98.0 to 99.0
|
2.343 units on a scale
Standard Error 1.641 • Interval -114.0 to 96.0
|
3.804 units on a scale
Standard Error 1.670 • Interval -86.0 to 95.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 108 weeksPopulation: All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).
Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study. To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as "offset" variable; treatment group, region of enrollment, baseline EDSS stratum and baseline number of Gd-enhancing T1-lesions as covariates).
Outcome measures
| Measure |
Placebo
n=346 Participants
Placebo (for teriflunomide) once daily for 108 weeks
|
Teriflunomide 7 mg
n=350 Participants
Teriflunomide 7 mg once daily for 108 weeks
|
Teriflunomide 14 mg
n=340 Participants
Teriflunomide 14 mg once daily for 108 weeks
|
|---|---|---|---|
|
Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)
|
1.331 lesions per scan
Interval 1.059 to 1.673
|
0.570 lesions per scan
Interval 0.434 to 0.748
|
0.261 lesions per scan
Interval 0.167 to 0.407
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 108 weeksPopulation: All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).
Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.
Outcome measures
| Measure |
Placebo
n=346 Participants
Placebo (for teriflunomide) once daily for 108 weeks
|
Teriflunomide 7 mg
n=350 Participants
Teriflunomide 7 mg once daily for 108 weeks
|
Teriflunomide 14 mg
n=340 Participants
Teriflunomide 14 mg once daily for 108 weeks
|
|---|---|---|---|
|
Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan
|
0.102 mililiters (mL)
Standard Deviation 0.329
|
0.059 mililiters (mL)
Standard Deviation 0.247
|
0.025 mililiters (mL)
Standard Deviation 0.079
|
Adverse Events
Placebo
Serious events: 46 serious events
Other events: 259 other events
Deaths: 0 deaths
Teriflunomide 7 mg
Serious events: 52 serious events
Other events: 271 other events
Deaths: 0 deaths
Teriflunomide 14 mg
Serious events: 57 serious events
Other events: 265 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=360 participants at risk
Placebo (for teriflunomide) once daily for 108 weeks
|
Teriflunomide 7 mg
n=368 participants at risk
Teriflunomide 7 mg once daily for 108 weeks
|
Teriflunomide 14 mg
n=358 participants at risk
Teriflunomide 14 mg once daily for 108 weeks
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.54%
2/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Cellulitis
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Cytomegalovirus hepatitis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.56%
2/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Hepatitis C
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Herpes zoster
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Influenza
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Lung infection
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.54%
2/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.84%
3/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Psychiatric disorders
Conversion disorder
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Psychiatric disorders
Depression
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.54%
2/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Psychiatric disorders
Panic attack
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Psychiatric disorders
Psychosomatic disease
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Psychiatric disorders
Somatoform disorder
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Glossopharyngeal neuralgia
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Hypertonia
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Multiple sclerosis
|
0.83%
3/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.84%
3/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Muscle spasticity
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
1.1%
4/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Intestinal functional disorder
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
1.6%
6/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Hepatobiliary disorders
Liver injury
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.83%
3/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.54%
2/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.56%
2/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Post abortion haemorrhage
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.54%
2/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Reproductive system and breast disorders
Fallopian tube cyst
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
General disorders
Asthenia
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
5/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
1.4%
5/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
1.4%
5/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.54%
2/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Investigations
Nuclear magnetic resonance imaging abdominal abnormal
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Investigations
Transaminases increased
|
0.56%
2/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.56%
2/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.28%
1/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.28%
1/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Surgical and medical procedures
Meniscus operation
|
0.00%
0/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.27%
1/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
0.00%
0/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
Other adverse events
| Measure |
Placebo
n=360 participants at risk
Placebo (for teriflunomide) once daily for 108 weeks
|
Teriflunomide 7 mg
n=368 participants at risk
Teriflunomide 7 mg once daily for 108 weeks
|
Teriflunomide 14 mg
n=358 participants at risk
Teriflunomide 14 mg once daily for 108 weeks
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
6.1%
22/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
4.9%
18/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
8.1%
29/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Gastroenteritis
|
4.2%
15/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
6.0%
22/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
5.6%
20/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Influenza
|
9.7%
35/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
9.2%
34/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
12.0%
43/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Nasopharyngitis
|
27.2%
98/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
25.5%
94/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
26.0%
93/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Sinusitis
|
4.4%
16/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
4.1%
15/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
6.4%
23/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
25/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
9.2%
34/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
8.9%
32/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Infections and infestations
Urinary tract infection
|
9.7%
35/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
7.3%
27/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
10.1%
36/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Psychiatric disorders
Depression
|
7.5%
27/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
7.1%
26/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
9.2%
33/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Psychiatric disorders
Insomnia
|
6.4%
23/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
5.4%
20/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
4.2%
15/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Dizziness
|
4.4%
16/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
6.0%
22/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
4.7%
17/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Headache
|
17.8%
64/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
22.0%
81/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
18.7%
67/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
30/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
4.9%
18/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
5.6%
20/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Nervous system disorders
Paraesthesia
|
8.3%
30/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
9.2%
34/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
9.8%
35/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.4%
16/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
4.1%
15/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
5.3%
19/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
24/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
4.6%
17/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
5.9%
21/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
15/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
5.2%
19/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
5.6%
20/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.9%
32/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
14.7%
54/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
17.9%
64/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Nausea
|
7.2%
26/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
8.7%
32/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
13.7%
49/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
14/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
4.1%
15/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
5.0%
18/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
12/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
10.3%
38/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
13.1%
47/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
15/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
3.8%
14/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
5.3%
19/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
30/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
8.2%
30/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
7.8%
28/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.8%
46/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
10.6%
39/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
11.2%
40/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.1%
22/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
4.3%
16/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
3.6%
13/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.4%
23/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
4.1%
15/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
3.9%
14/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.1%
47/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
7.1%
26/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
9.2%
33/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
General disorders
Fatigue
|
14.2%
51/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
12.8%
47/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
14.5%
52/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
|
Investigations
Alanine aminotransferase increased
|
5.8%
21/360 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
11.1%
41/368 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
13.1%
47/358 • All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last intake or up to first intake in the extension study, whichever came first (124 weeks max). Participants who received incorrect treatment were included considering the incorrect treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator can publish only the results of the work performed pursuant to this protocol. Prior to publication, the investigator provides the sponsor with the manuscript for review and comment at least 45 days in advance of its submission for publication. The sponsor can require the investigator to withhold publication an additional 90 days to allow for filing a patent application or taking such other measures as sponsor deems appropriate to establish and preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER