Trial Outcomes & Findings for Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy (NCT NCT01339559)
NCT ID: NCT01339559
Last Updated: 2021-08-17
Results Overview
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
767 participants
Primary outcome timeframe
From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Results posted on
2021-08-17
Participant Flow
The study started to enroll patients in May 2011 and concluded in April 2019. 767 participants were included in the Enrolled Set but 1 participant from the United States of America was lost to follow-up and was excluded from the Safety Analysis Set.
Participants Flow refers to the Safety Set (SS).
Participant milestones
| Measure |
Brivaracetam
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period.
|
|---|---|
|
Overall Study
STARTED
|
766
|
|
Overall Study
COMPLETED
|
368
|
|
Overall Study
NOT COMPLETED
|
398
|
Reasons for withdrawal
| Measure |
Brivaracetam
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period.
|
|---|---|
|
Overall Study
Adverse Event
|
92
|
|
Overall Study
Death
|
5
|
|
Overall Study
Lack of Efficacy
|
164
|
|
Overall Study
Lost to Follow-up
|
22
|
|
Overall Study
Subject choice
|
89
|
|
Overall Study
Protocol Violation
|
15
|
|
Overall Study
Study closure at site
|
1
|
|
Overall Study
Incarcerated
|
2
|
|
Overall Study
Epilepsy surgery
|
1
|
|
Overall Study
Pregnancy planned
|
2
|
|
Overall Study
Left the country
|
1
|
|
Overall Study
Investigator decision
|
2
|
|
Overall Study
Patient didn't wish to continue
|
1
|
|
Overall Study
PI decision
|
1
|
Baseline Characteristics
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
Baseline characteristics by cohort
| Measure |
Brivaracetam
n=766 Participants
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period.
|
|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
722 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=93 Participants
|
|
Age, Continuous
|
40.0 years
STANDARD_DEVIATION 12.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
396 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
370 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
561 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
African-American
|
37 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
85 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
77 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Missing
|
6 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From Entry Visit (Month 0) until the Last Visit (up to 84 months)Population: The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug.
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.
Outcome measures
| Measure |
Brivaracetam (SS)
n=766 Participants
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
|
|---|---|
|
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
|
83.9 Percentage of participants
|
PRIMARY outcome
Timeframe: From Entry Visit (Month 0) until the Last Visit (up to 84 months)Population: The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug.
An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Outcome measures
| Measure |
Brivaracetam (SS)
n=766 Participants
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
|
|---|---|
|
Percentage of Participants Who Withdrew Due to Adverse Events (AEs)
|
11.9 Percentage of participants
|
PRIMARY outcome
Timeframe: From Entry Visit (Month 0) until the Last Visit (up to 84 months)Population: The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug.
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is as infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
Outcome measures
| Measure |
Brivaracetam (SS)
n=766 Participants
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
|
|---|---|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE)
|
18.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline of the previous study until the Last Visit (up to 84 months)Population: The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.
The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.
Outcome measures
| Measure |
Brivaracetam (SS)
n=749 Participants
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
|
|---|---|
|
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
Baseline
|
9.7 Seizures per 28 days
Interval 5.5 to 23.7
|
|
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
On Treatment
|
4.2 Seizures per 28 days
Interval 1.4 to 12.7
|
SECONDARY outcome
Timeframe: From Baseline of the previous study until the Last Visit (up to 84 months)Population: The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period. Participants from N01258 were excluded from this analysis.
The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as: (the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines. Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of percent change in POS frequency.
Outcome measures
| Measure |
Brivaracetam (SS)
n=675 Participants
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
|
|---|---|
|
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
|
52.0 Percent change
Interval 16.8 to 81.5
|
SECONDARY outcome
Timeframe: From Baseline of the previous study until the Last Visit (up to 84 months)Population: The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period. Participants from N01258 were excluded from this analysis.
A responder is defined as a subject with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study. Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of responder rates in POS frequency.
Outcome measures
| Measure |
Brivaracetam (SS)
n=675 Participants
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
|
|---|---|
|
Responder Rate in POS (Type I) Frequency Over the Evaluation Period
|
51.7 Percentage of participants
|
Adverse Events
Brivaracetam (SS)
Serious events: 140 serious events
Other events: 421 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Brivaracetam (SS)
n=766 participants at risk
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
|
|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Blood and lymphatic system disorders
Hypoplastic anaemia
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Cardiac disorders
Cardiac arrest
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Cardiac disorders
Cardiac failure
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Cardiac disorders
Myocardial infarction
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Cardiac disorders
Angina pectoris
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Cardiac disorders
Coronary artery stenosis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Endocrine disorders
Goitre
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Eye disorders
Diplopia
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
General disorders
Pyrexia
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
General disorders
Asthenia
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
General disorders
Device malfunction
|
0.13%
1/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
General disorders
Non-cardiac chest pain
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.39%
3/766 • Number of events 3 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Pneumonia
|
0.65%
5/766 • Number of events 5 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Sepsis
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Appendicitis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Appendicitis perforated
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Diverticulitis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Gastroenteritis escherichia coli
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Infected cyst
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Infection
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Osteomyelitis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Otitis media chronic
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Perineal abscess
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Pharyngitis bacterial
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Typhoid fever
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Urinary tract infection
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Wound infection
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.39%
3/766 • Number of events 4 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Laceration
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Investigations
Diagnostic procedure
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Investigations
Transaminases increased
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Investigations
Troponin increased
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Investigations
Weight decreased
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.39%
3/766 • Number of events 3 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gliomatosis cerebri
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Convulsion
|
2.0%
15/766 • Number of events 16 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Status epilepticus
|
1.4%
11/766 • Number of events 11 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Epilepsy
|
0.91%
7/766 • Number of events 7 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Seizure cluster
|
0.52%
4/766 • Number of events 4 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Headache
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Ischaemic stroke
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Ataxia
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Balance disorder
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Cerebellar syndrome
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Cervical cord compression
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Complex partial seizures
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Encephalitis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Grand mal convulsion
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Hemiparesis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Hydrocephalus
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Loss of consciousness
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Myelopathy
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Polyneuropathy
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Radiculopathy
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Simple partial seizures
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Somnolence
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Pregnancy, puerperium and perinatal conditions
Imminent abortion
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Suicide attempt
|
0.91%
7/766 • Number of events 7 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Suicidal ideation
|
0.65%
5/766 • Number of events 5 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Acute psychosis
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Depression
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Aggression
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Anxiety
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Anxiety disorder
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Confusional state
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Delirium
|
0.13%
1/766 • Number of events 3 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Delirium febrile
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Emotional disorder
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Renal and urinary disorders
Renal colic
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.26%
2/766 • Number of events 2 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Reproductive system and breast disorders
Spermatic cord haemorrhage
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Surgical and medical procedures
Tenodesis
|
0.13%
1/766 • Number of events 1 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
Other adverse events
| Measure |
Brivaracetam (SS)
n=766 participants at risk
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
|
|---|---|
|
General disorders
Fatigue
|
7.7%
59/766 • Number of events 67 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
65/766 • Number of events 102 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
59/766 • Number of events 101 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Urinary tract infection
|
7.4%
57/766 • Number of events 86 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Infections and infestations
Influenza
|
5.2%
40/766 • Number of events 47 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
5.7%
44/766 • Number of events 71 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
43/766 • Number of events 60 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
46/766 • Number of events 59 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
41/766 • Number of events 56 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Headache
|
13.3%
102/766 • Number of events 187 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Dizziness
|
13.1%
100/766 • Number of events 123 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Nervous system disorders
Somnolence
|
9.5%
73/766 • Number of events 88 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Depression
|
5.9%
45/766 • Number of events 53 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
|
Psychiatric disorders
Anxiety
|
5.5%
42/766 • Number of events 48 • From Entry Visit (Month 0) until the Last Visit (up to 84 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60