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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004334-26 | EudraCT Number |
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This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 [NCT00160165] or N01221 [NCT00280696].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted) | 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. | During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi-gun | Aichi-ken | Japan | ||||
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Levetiracetam N01020 [NCT00160615] |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Period (16 Weeks) |
|
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|
| Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
| Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study | 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. | First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16) |
| 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) | 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. | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
| Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study | 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. | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
| Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study | 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. | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
| Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study | 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:
| Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
| Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study | 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. | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
| Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study | 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). | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
| Nagoya |
| Aichi-ken |
| Japan |
| Hirosaki | Aomori | Japan |
| Matsudo | Chiba | Japan |
| Kitakyushu | Fukuoka | Japan |
| Koga | Fukuoka | Japan |
| Kurume | Fukuoka | Japan |
| Fukuyama | Hiroshima | Japan |
| Asahikawa | Hokkaido | Japan |
| Hakodate | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Kobe | Hyōgo | Japan |
| Kahoku-gun | Ishikawa-ken | Japan |
| Kanazawa | Ishikawa-ken | Japan |
| Zentsujichó | Kagawa-ken | Japan |
| Kōshi | Kumamoto | Japan |
| Tsu | Mie-ken | Japan |
| Iwanuma | Miyagi | Japan |
| Sendai | Miyagi | Japan |
| Ōmura | Nagasaki | Japan |
| Kashihara | Nara | Japan |
| Nagaoka | Niigata | Japan |
| Beppu | Oita Prefecture | Japan |
| Izumi | Osaka | Japan |
| Neyagawa | Osaka | Japan |
| Suita | Osaka | Japan |
| Takatsuki | Osaka | Japan |
| Iruma-gun | Saitama | Japan |
| Shimotsuga-gun | Tochigi | Japan |
| Shimotsuke | Tochigi | Japan |
| Komatsushimachō | Tokushima | Japan |
| Chiyoda-Ku | Tokyo | Japan |
| Kodaira | Tokyo | Japan |
| Kokubunji | Tokyo | Japan |
| Shinjuku-ku | Tokyo | Japan |
| Taito-ku | Tokyo | Japan |
| Ube | Yamaguchi | Japan |
| Aomori | Japan |
| Chiba | Japan |
| Fukuoka | Japan |
| Fukushima | Japan |
| Gifu | Japan |
| Hiroshima | Japan |
| Kagoshima | Japan |
| Kumamoto | Japan |
| Kyoto | Japan |
| Miyazaki | Japan |
| Niigata | Japan |
| Okayama | Japan |
| Osaka | Japan |
| Shizuoka | Japan |
| Toyama | Japan |
| Yamagata | Japan |
N01020 [NCT00160615] was an open-label follow-up study to evaluate safety and efficacy of Levetiracetam. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Second Period (up to 54 Months) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Weight | Mean | Standard Deviation | Kilogram (kg) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted) | 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. | Safety Set includes all subjects from N01221 [NCT00280696] and N01020 [NCT00160615] administered the investigational products at least once. | Posted | Number | participants | During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study | 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. | Full Analysis Set (FAS). | Posted | Median | Inter-Quartile Range | Percent Reduction | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
|
| ||||||||||||||||||||||||||
| Secondary | Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study | 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. | Full Analysis Set (FAS). | Posted | Median | Inter-Quartile Range | Seizures Per Week | First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16) |
|
| ||||||||||||||||||||||||||
| Secondary | 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) | 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. | Full Analysis Set (FAS). | Posted | Number | Participants | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study | 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. | Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple Partial Seizures. | Posted | Median | Inter-Quartile Range | Percent Reduction | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study | 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. | Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Complex Partial Seizures. | Posted | Median | Inter-Quartile Range | Percent Reduction | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study | 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:
| Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Secondary Generalized Seizures. | Posted | Median | Inter-Quartile Range | Percent Reduction | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study | 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. | Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple and Complex Partial Seizures. | Posted | Median | Inter-Quartile Range | Percent Reduction | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study | 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). | Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Other Types of Seizures. | Posted | Median | Inter-Quartile Range | Percent Reduction | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levetiracetam | 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). | 64 | 398 | 369 | 398 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion Complete | Pregnancy, puerperium and perinatal conditions | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abortion Induced | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Acute Psychosis | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Acute Sinusitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anticonvulsant Drug Level Increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anticonvulsant Toxicity | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Brain Operation | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Burns Second Degree | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cervical Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Complex Partial Seizures | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Drug Withdrawal Convulsions | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Electrocardiogram ST Segment Elevation | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Eyelid Ptosis | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastroenteritis Escherichia Coli | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Head Titubation | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ideas of Reference | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Infected Epidermal Cyst | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Injection Site Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Irritable Bowel Syndrome | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Jaw Disorder | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lactation Disorder | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Medical Diet | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Mental Disorder | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Morose | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia Mycoplasmal | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Postictal State | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rectal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Skull Fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Small Intestine Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Status Epilepticus | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sudden Unexplained Death in Epilepsy | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urethral Stenosis | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Wisdom Teeth Removal | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
| |
| Colonic Polyp | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dental Caries | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Joint Sprain | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 (UCB) |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Lost to Follow-up |
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| Withdrawal by Subject |
|
| Other Reason |
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