Trial Outcomes & Findings for A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures (NCT NCT00367432)
NCT ID: NCT00367432
Last Updated: 2020-11-13
Results Overview
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
398 participants
Primary outcome timeframe
During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted
Results posted on
2020-11-13
Participant Flow
The Full Analysis Set (FAS) includes all subjects to whom the investigational products are assigned after registration, excluding those with serious Good Clinical Practice violations , subjects not administered the investigational products and subjects for whom no data is available after assignment of the investigational products.
Eligible subjects from preceding study N01221 \[NCT00280696\] entered the First Period of this study and those subjects from N01221 \[NCT00280696\] who completed the First Period and subjects from the study N01020 \[NCT00160615\] entered the Second Period. Participant Flow and Baseline Characteristics refer to the FAS.
Participant milestones
| Measure |
Levetiracetam N01221 [NCT00280696]
N01221 \[NCT00280696\] was a double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluate the efficacy and safety of Levetiracetam.
|
Levetiracetam N01020 [NCT00160615]
N01020 \[NCT00160615\] was an open-label follow-up study to evaluate safety and efficacy of Levetiracetam.
|
|---|---|---|
|
First Period (16 Weeks)
STARTED
|
313
|
0
|
|
First Period (16 Weeks)
COMPLETED
|
275
|
0
|
|
First Period (16 Weeks)
NOT COMPLETED
|
38
|
0
|
|
Second Period (up to 54 Months)
STARTED
|
275
|
85
|
|
Second Period (up to 54 Months)
COMPLETED
|
188
|
69
|
|
Second Period (up to 54 Months)
NOT COMPLETED
|
87
|
16
|
Reasons for withdrawal
| Measure |
Levetiracetam N01221 [NCT00280696]
N01221 \[NCT00280696\] was a double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluate the efficacy and safety of Levetiracetam.
|
Levetiracetam N01020 [NCT00160615]
N01020 \[NCT00160615\] was an open-label follow-up study to evaluate safety and efficacy of Levetiracetam.
|
|---|---|---|
|
First Period (16 Weeks)
Adverse Event
|
6
|
0
|
|
First Period (16 Weeks)
Lack of Efficacy
|
24
|
0
|
|
First Period (16 Weeks)
Withdrawal by Subject
|
6
|
0
|
|
First Period (16 Weeks)
Other Reason
|
2
|
0
|
|
Second Period (up to 54 Months)
Adverse Event
|
14
|
3
|
|
Second Period (up to 54 Months)
Lack of Efficacy
|
59
|
5
|
|
Second Period (up to 54 Months)
Lost to Follow-up
|
0
|
1
|
|
Second Period (up to 54 Months)
Withdrawal by Subject
|
8
|
5
|
|
Second Period (up to 54 Months)
Other Reason
|
6
|
2
|
Baseline Characteristics
A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures
Baseline characteristics by cohort
| Measure |
Levetiracetam
n=398 Participants
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
|---|---|
|
Age, Continuous
|
33.68 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
|
Age, Customized
Between 16 and 65 years
|
398 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
396 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (other than Japanese)
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
398 participants
n=5 Participants
|
|
Weight
|
60.39 Kilogram (kg)
STANDARD_DEVIATION 13.64 • n=5 Participants
|
PRIMARY outcome
Timeframe: During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval grantedPopulation: Safety Set includes all subjects from N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE.
Outcome measures
| Measure |
Levetiracetam
n=398 Participants
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
|---|---|
|
Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)
|
381 participants
|
SECONDARY outcome
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this studyPopulation: Full Analysis Set (FAS).
The change in partial (type 1) seizure frequency from Baseline is given as a percent reduction computed as: \[ Weekly partial seizure frequency (Baseline)- Weekly partial seizure frequency (Evaluation Period)\]/ \[Weekly partial seizure frequency (Baseline)\] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Outcome measures
| Measure |
Levetiracetam
n=313 Participants
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
|---|---|
|
Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study
|
22.00 Percent Reduction
Inter-Quartile Range 53.04 • Interval -11.0 to 46.71
|
SECONDARY outcome
Timeframe: First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16)Population: Full Analysis Set (FAS).
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Outcome measures
| Measure |
Levetiracetam
n=313 Participants
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
|---|---|
|
Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study
|
2.13 Seizures Per Week
Inter-Quartile Range 7.32 • Interval 1.06 to 5.23
|
SECONDARY outcome
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this studyPopulation: Full Analysis Set (FAS).
The percent reduction from Baseline was computed as: \[ Weekly seizure frequency (Baseline)- Weekly seizure frequency (Evaluation Period)\]/ \[Weekly seizure frequency (Baseline)\] x 100. Responders are those patients with a percent reduction in partial seizure frequency of at least 50% from Baseline to first Evaluation Period in partial seizure frequency per week. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Outcome measures
| Measure |
Levetiracetam
n=313 Participants
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
|---|---|
|
Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)
Responders
|
74 Participants
|
|
Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)
Non-responders
|
239 Participants
|
SECONDARY outcome
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this studyPopulation: Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple Partial Seizures.
Change in simple partial seizure frequency is given as a percent reduction computed as: \[ Weekly simple partial seizure frequency (Baseline)- Weekly simple partial seizure frequency (Evaluation Period)\]/ \[Weekly simple partial seizure frequency (Baseline)\] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Outcome measures
| Measure |
Levetiracetam
n=173 Participants
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
|---|---|
|
Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study
|
39.84 Percent Reduction
Inter-Quartile Range 139.32 • Interval -17.19 to 94.96
|
SECONDARY outcome
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this studyPopulation: Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Complex Partial Seizures.
Change in complex partial seizure frequency is given as a percent reduction computed as: \[ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)\]/ \[Weekly complex partial seizure frequency (Baseline)\] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Outcome measures
| Measure |
Levetiracetam
n=285 Participants
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
|---|---|
|
Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
|
20.59 Percent Reduction
Inter-Quartile Range 85.94 • Interval -15.24 to 52.94
|
SECONDARY outcome
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this studyPopulation: Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Secondary Generalized Seizures.
Change in secondary generalized seizure frequency is given as a percent reduction computed as: \[ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)\]/ \[Weekly sec. generalized seizure frequency (Baseline)\] x 100. Positive values in reduction means the value decreased from Baseline during the first 16-week Period. Secondary generalized seizures belong to one of the 3 groups: * Simple partial sz evolving to gen sz * Complex partial sz evolving to gen sz * Simple partial sz evolving to Complex partial sz evolving to gen sz
Outcome measures
| Measure |
Levetiracetam
n=87 Participants
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
|---|---|
|
Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study
|
76.56 Percent Reduction
Inter-Quartile Range 249.71 • Interval 23.11 to 100.0
|
SECONDARY outcome
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this studyPopulation: Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple and Complex Partial Seizures.
Change in simple and complex partial seizure frequency is given as a percent reduction computed as (simple and complex partial seizure frequency := A): \[ Weekly A (Baseline)- Weekly A (Evaluation Period)\]/ \[Weekly A (Baseline)\] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Outcome measures
| Measure |
Levetiracetam
n=308 Participants
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
|---|---|
|
Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
|
20.71 Percent Reduction
Inter-Quartile Range 63.01 • Interval -13.17 to 47.42
|
SECONDARY outcome
Timeframe: Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this studyPopulation: Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Other Types of Seizures.
Change in other types of seizure frequency is given as a percent reduction computed as (other types of seizure frequency:= B): \[ Weekly B (Baseline)- Weekly B (Evaluation Period)\]/ \[Weekly B (Baseline)\] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Other types of Seizures are all seizures except Partial Seizures (Type 1).
Outcome measures
| Measure |
Levetiracetam
n=5 Participants
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
|---|---|
|
Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study
|
66.47 Percent Reduction
Inter-Quartile Range 71.28 • Interval 7.48 to 100.0
|
Adverse Events
Levetiracetam
Serious events: 64 serious events
Other events: 369 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levetiracetam
n=398 participants at risk
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion Complete
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Surgical and medical procedures
Abortion Induced
|
0.50%
2/398 • Number of events 2 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Psychiatric disorders
Acute Psychosis
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Acute Sinusitis
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Investigations
Anticonvulsant Drug Level Increased
|
0.50%
2/398 • Number of events 2 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Anticonvulsant Toxicity
|
0.75%
3/398 • Number of events 3 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Surgical and medical procedures
Brain Operation
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Burns Second Degree
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Cellulitis
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Cerebral Infarction
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Complex Partial Seizures
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Convulsion
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Psychiatric disorders
Depression
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Dizziness
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Drug Withdrawal Convulsions
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Investigations
Electrocardiogram ST Segment Elevation
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Epilepsy
|
1.3%
5/398 • Number of events 5 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Eye disorders
Eyelid Ptosis
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Gastroenteritis Escherichia Coli
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Psychiatric disorders
Hallucination
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Head Titubation
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Psychiatric disorders
Ideas of Reference
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Ileus
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Infected Epidermal Cyst
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Injection Site Infection
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Jaw Disorder
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Reproductive system and breast disorders
Lactation Disorder
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Lobar Pneumonia
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Surgical and medical procedures
Medical Diet
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Psychiatric disorders
Mental Disorder
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Psychiatric disorders
Morose
|
0.25%
1/398 • Number of events 3 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
General disorders
Pain
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Cardiac disorders
Palpitations
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Pneumonia
|
1.0%
4/398 • Number of events 4 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Pneumonia Mycoplasmal
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Postictal State
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Pyelonephritis
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
General disorders
Pyrexia
|
0.50%
2/398 • Number of events 2 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Rectal Ulcer Haemorrhage
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Sepsis
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.75%
3/398 • Number of events 3 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Skull Fracture
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Intestine Carcinoma
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Status Epilepticus
|
1.3%
5/398 • Number of events 9 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
General disorders
Sudden Unexplained Death in Epilepsy
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Psychiatric disorders
Suicide Attempt
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.25%
1/398 • Number of events 2 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Surgical and medical procedures
Wisdom Teeth Removal
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.25%
1/398 • Number of events 1 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
Other adverse events
| Measure |
Levetiracetam
n=398 participants at risk
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
9.5%
38/398 • Number of events 67 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.0%
20/398 • Number of events 40 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Constipation
|
11.3%
45/398 • Number of events 70 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.3%
69/398 • Number of events 128 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
44/398 • Number of events 53 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Stomatitis
|
10.6%
42/398 • Number of events 75 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Toothache
|
5.3%
21/398 • Number of events 32 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Gastrointestinal disorders
Vomiting
|
10.1%
40/398 • Number of events 85 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
General disorders
Pyrexia
|
13.1%
52/398 • Number of events 95 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Immune system disorders
Seasonal Allergy
|
7.3%
29/398 • Number of events 43 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Dental Caries
|
10.6%
42/398 • Number of events 49 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Gastroenteritis
|
6.8%
27/398 • Number of events 34 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Influenza
|
8.0%
32/398 • Number of events 32 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Nasopharyngitis
|
77.4%
308/398 • Number of events 1360 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Pharyngitis
|
6.3%
25/398 • Number of events 38 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Infections and infestations
Rhinitis
|
5.5%
22/398 • Number of events 26 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Contusion
|
27.6%
110/398 • Number of events 237 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Excoriation
|
13.1%
52/398 • Number of events 85 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Injury
|
8.3%
33/398 • Number of events 39 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
6.8%
27/398 • Number of events 37 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.0%
20/398 • Number of events 23 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
7.8%
31/398 • Number of events 53 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
9.0%
36/398 • Number of events 43 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Investigations
Weight Decreased
|
7.0%
28/398 • Number of events 33 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
31/398 • Number of events 34 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.3%
45/398 • Number of events 70 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
21/398 • Number of events 27 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Dizziness
|
15.8%
63/398 • Number of events 92 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Epilepsy
|
7.8%
31/398 • Number of events 37 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Headache
|
24.1%
96/398 • Number of events 261 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Nervous system disorders
Somnolence
|
39.9%
159/398 • Number of events 226 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Psychiatric disorders
Insomnia
|
6.0%
24/398 • Number of events 26 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
21/398 • Number of events 25 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
8.0%
32/398 • Number of events 60 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
5.0%
20/398 • Number of events 26 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
8.3%
33/398 • Number of events 46 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.8%
47/398 • Number of events 61 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
21/398 • Number of events 25 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
26/398 • Number of events 37 • Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 \[NCT00280696\] and N01020 \[NCT00160615\] administered the investigational products at least once.
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +1 877 822 9493 (UCB)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60