Trial Outcomes & Findings for Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older (NCT NCT01243177)
NCT ID: NCT01243177
Last Updated: 2021-02-02
Results Overview
The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
888 participants
Primary outcome timeframe
6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject
Results posted on
2021-02-02
Participant Flow
This study started to enroll in April 2011 and concluded in August 2015.
Participant Flow refers to the Safety Analysis Set which is defined as all randomized subjects who took at least 1 dose of study medication and is identical with the Full Analysis Set.
Participant milestones
| Measure |
Lacosamide
* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks
|
Carbamazepine-Controlled Release (CBZ-CR)
* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
444
|
442
|
|
Overall Study
COMPLETED
|
266
|
264
|
|
Overall Study
NOT COMPLETED
|
178
|
178
|
Reasons for withdrawal
| Measure |
Lacosamide
* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks
|
Carbamazepine-Controlled Release (CBZ-CR)
* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
47
|
31
|
|
Overall Study
Protocol Violation
|
11
|
10
|
|
Overall Study
Lost to Follow-up
|
15
|
18
|
|
Overall Study
Withdrawal by Subject
|
46
|
38
|
|
Overall Study
AE, serious fatal
|
0
|
1
|
|
Overall Study
SAE, non-fatal
|
7
|
9
|
|
Overall Study
AE, non-serious non-fatal
|
40
|
58
|
|
Overall Study
SAE, fatal + SAE, non-fatal
|
1
|
0
|
|
Overall Study
SAE,non-fatal+AE,non-serious non-fatal
|
0
|
1
|
|
Overall Study
Other Reason
|
11
|
12
|
Baseline Characteristics
Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
Baseline characteristics by cohort
| Measure |
Lacosamide
n=444 Participants
* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks
|
Carbamazepine-Controlled Release (CBZ-CR)
n=442 Participants
* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks
|
Total Title
n=886 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
27 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
355 Participants
n=99 Participants
|
366 Participants
n=107 Participants
|
721 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
62 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Age, Continuous
|
41.9 years
STANDARD_DEVIATION 17.9 • n=99 Participants
|
41.8 years
STANDARD_DEVIATION 17.2 • n=107 Participants
|
41.8 years
STANDARD_DEVIATION 17.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
201 Participants
n=99 Participants
|
210 Participants
n=107 Participants
|
411 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
243 Participants
n=99 Participants
|
232 Participants
n=107 Participants
|
475 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subjectPopulation: Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.
The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Lacosamide
n=444 Participants
* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks
|
Carbamazepine-Controlled Release (CBZ-CR)
n=442 Participants
* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks
|
|---|---|---|
|
Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject
|
89.8 percentage of subjects
Interval 86.8 to 92.8
|
91.1 percentage of subjects
Interval 88.2 to 94.0
|
PRIMARY outcome
Timeframe: 6 consecutive months (26 consecutive weeks) of treatmentPopulation: The Per Protocol Set (PPS) was defined as containing all subjects in the Full Analysis Set (FAS) who did not have any important protocol deviations determined to impact the interpretation of primary efficacy.
The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Lacosamide
n=408 Participants
* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks
|
Carbamazepine-Controlled Release (CBZ-CR)
n=397 Participants
* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks
|
|---|---|---|
|
Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject
|
91.4 percentage of subjects
Interval 88.5 to 94.3
|
92.8 percentage of subjects
Interval 90.1 to 95.6
|
PRIMARY outcome
Timeframe: Duration of the Treatment Phase (up to 113 weeks)Population: Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.
Outcome measures
| Measure |
Lacosamide
n=444 Participants
* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks
|
Carbamazepine-Controlled Release (CBZ-CR)
n=442 Participants
* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks
|
|---|---|---|
|
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)
|
328 Participants
|
332 Participants
|
PRIMARY outcome
Timeframe: Duration of the Treatment Phase (up to 113 weeks)Population: Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.
Outcome measures
| Measure |
Lacosamide
n=444 Participants
* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks
|
Carbamazepine-Controlled Release (CBZ-CR)
n=442 Participants
* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks
|
|---|---|---|
|
Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)
|
47 Participants
|
69 Participants
|
PRIMARY outcome
Timeframe: Duration of the Treatment Phase (up to 113 weeks)Population: Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.
Outcome measures
| Measure |
Lacosamide
n=444 Participants
* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks
|
Carbamazepine-Controlled Release (CBZ-CR)
n=442 Participants
* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks
|
|---|---|---|
|
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)
|
32 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 12 consecutive months of treatment following stabilization at the last evaluated dose for each subjectPopulation: Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.
The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Lacosamide
n=444 Participants
* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks
|
Carbamazepine-Controlled Release (CBZ-CR)
n=442 Participants
* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks
|
|---|---|---|
|
Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject
|
77.8 percentage of subjects
Interval 73.4 to 82.2
|
82.7 percentage of subjects
Interval 78.5 to 86.8
|
Adverse Events
Lacosamide
Serious events: 36 serious events
Other events: 165 other events
Deaths: 0 deaths
Carbamazepine-Controlled Release (CBZ-CR)
Serious events: 46 serious events
Other events: 181 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide
n=444 participants at risk
* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks
|
Carbamazepine-Controlled Release (CBZ-CR)
n=442 participants at risk
* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks
|
|---|---|---|
|
Nervous system disorders
Convulsion
|
0.90%
4/444 • Number of events 4 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.45%
2/442 • Number of events 3 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Complex partial seizures
|
0.45%
2/444 • Number of events 2 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic astrocytoma
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Cardiac disorders
Angina pectoris
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Cardiac disorders
Sinus tachycardia
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.23%
1/444 • Number of events 2 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
General disorders
Gait disturbance
|
0.45%
2/444 • Number of events 2 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
General disorders
Inflammation
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.45%
2/444 • Number of events 2 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 2 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Investigations
Smear cervix abnormal
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Epilepsy
|
0.45%
2/444 • Number of events 3 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Dyskinesia
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Motor neurone disease
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Preictal state
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.68%
3/442 • Number of events 3 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.45%
2/442 • Number of events 2 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.45%
2/442 • Number of events 2 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.45%
2/442 • Number of events 2 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Psychiatric disorders
Aggression
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Psychiatric disorders
Agitation
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.23%
1/444 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.00%
0/442 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.45%
2/442 • Number of events 2 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 1 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/444 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
0.23%
1/442 • Number of events 2 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
Other adverse events
| Measure |
Lacosamide
n=444 participants at risk
* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks
|
Carbamazepine-Controlled Release (CBZ-CR)
n=442 participants at risk
* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.9%
26/444 • Number of events 32 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
5.2%
23/442 • Number of events 30 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
7.7%
34/444 • Number of events 38 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
11.1%
49/442 • Number of events 55 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
29/444 • Number of events 42 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
6.6%
29/442 • Number of events 37 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.6%
7/444 • Number of events 8 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
7.9%
35/442 • Number of events 36 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
13.5%
60/444 • Number of events 82 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
13.1%
58/442 • Number of events 78 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
11.9%
53/444 • Number of events 61 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
9.3%
41/442 • Number of events 52 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
|
Nervous system disorders
Somnolence
|
6.1%
27/444 • Number of events 28 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
9.3%
41/442 • Number of events 47 • Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
|
Additional Information
UCB (Study Director)
UCB Cares
Phone: +1 887 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60