Trial Outcomes & Findings for Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy (NCT NCT00175916)
NCT ID: NCT00175916
Last Updated: 2021-08-17
Results Overview
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 an 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
853 participants
Primary outcome timeframe
From Entry Visit until Last Visit (up to 162 months)
Results posted on
2021-08-17
Participant Flow
The study started to enroll patients in September 2005 and concluded in May 2019.
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
|
853
|
|
Overall Study
COMPLETED
|
234
|
|
Overall Study
NOT COMPLETED
|
619
|
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
Death
|
19
|
|
Overall Study
Adverse Event
|
81
|
|
Overall Study
Lack of Efficacy
|
354
|
|
Overall Study
Lost to Follow-up
|
17
|
|
Overall Study
Subject Choice
|
98
|
|
Overall Study
Lack of compliance
|
8
|
|
Overall Study
Patient cannot record seizures
|
1
|
|
Overall Study
Sponsor decision
|
17
|
|
Overall Study
Vigabatrin intake
|
1
|
|
Overall Study
Suicidal behaviour
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Seizure - free
|
4
|
|
Overall Study
Administrative reason
|
1
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Patient's request
|
2
|
|
Overall Study
Treating physiciant's choice
|
1
|
|
Overall Study
Moved overseas
|
1
|
|
Overall Study
Loss of job and economic burden
|
1
|
|
Overall Study
Site was closed
|
9
|
|
Overall Study
Patient went to prison
|
1
|
Baseline Characteristics
Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
Baseline characteristics by cohort
| Measure |
Brivaracetam
n=853 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
|
14 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
827 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
418 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
435 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
721 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
123 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Entry Visit until Last Visit (up to 162 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=853 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)
|
84.4 Percentage of participants
|
PRIMARY outcome
Timeframe: From Entry Visit until Last Visit (up to 162 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 participant 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=853 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 an Adverse Event (AE)
|
11.6 Percentage of participants
|
PRIMARY outcome
Timeframe: From Entry Visit until Last Visit (up to 162 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 an 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=853 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)
|
29.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From Entry Visit until Last Visit (up to 162 months)Population: The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all participants 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. Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 \[NCT00175929\], N01252 \[NCT00490035\] and N01254 \[NCT00504881\].
Outcome measures
| Measure |
Brivaracetam (SS)
n=729 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
|
8.4 Seizures per 28 days
Interval 5.0 to 16.1
|
|
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
On Treatment
|
4.9 Seizures per 28 days
Interval 2.1 to 10.8
|
SECONDARY outcome
Timeframe: From Entry Visit until Last Visit (up to 162 months)Population: The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all participants with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.
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. Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 \[NCT00175929\], N01252 \[NCT00490035\] and N01254 \[NCT00504881\].
Outcome measures
| Measure |
Brivaracetam (SS)
n=729 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
|
43.1 Percent change
Interval 9.9 to 71.5
|
SECONDARY outcome
Timeframe: From Entry Visit until Last Visit (up to 162 months)Population: The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all participants with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.
A responder is defined as a participant with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study. Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 \[NCT00175929\], N01252 \[NCT00490035\] and N01254 \[NCT00504881\].
Outcome measures
| Measure |
Brivaracetam (SS)
n=729 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
|
43.6 Percentage of participants
|
Adverse Events
Brivaracetam (SS)
Serious events: 248 serious events
Other events: 569 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Brivaracetam (SS)
n=853 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
Anaemia macrocytic
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Cardiac disorders
Angina pectoris
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Cardiac disorders
Atrial flutter
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Cardiac disorders
Cardiac disorder
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Cardiac disorders
Cardiac failure
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Cardiac disorders
Coronary artery disease
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Cardiac disorders
Myocardial infarction
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Cardiac disorders
Sinus tachycardia
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Congenital, familial and genetic disorders
Baltic myoclonic epilepsy
|
0.23%
2/853 • Number of events 5 • From Entry Visit until Last Visit (up to 162 months)
|
|
Ear and labyrinth disorders
Vertigo
|
0.47%
4/853 • Number of events 6 • From Entry Visit until Last Visit (up to 162 months)
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Endocrine disorders
Hypothyroidism
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Endocrine disorders
Thyroiditis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Eye disorders
Cataract
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Eye disorders
Corneal erosion
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Eye disorders
Opsoclonus myoclonus
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Eye disorders
Vision blurred
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Eye disorders
Visual impairment
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.59%
5/853 • Number of events 5 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.35%
3/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Constipation
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.23%
2/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.23%
2/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Gastritis
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Nausea
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Anal fissure
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Colitis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Duodenitis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Enteritis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Gastric polyps
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Ileus
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.12%
1/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.12%
1/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Proctocolitis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Pyrexia
|
0.59%
5/853 • Number of events 5 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Death
|
0.47%
4/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Fatigue
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Unevaluable event
|
0.23%
2/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Chest pain
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Device failure
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Drowning
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Gait disturbance
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Haemorrhagic cyst
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Implant site haematoma
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Irritability
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Sudden death
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.35%
3/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Hepatobiliary disorders
Biliary colic
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Immune system disorders
Anaphylactic reaction
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Immune system disorders
Immunodeficiency
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Pneumonia
|
1.1%
9/853 • Number of events 14 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Sepsis
|
0.70%
6/853 • Number of events 6 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.47%
4/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Urinary tract infection
|
0.47%
4/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Appendicitis
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Postoperative wound infection
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Pyelonephritis
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Septic shock
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Skin infection
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Bronchitis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Bronchopneumonia
|
0.12%
1/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Device related infection
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Ear infection
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Gastroenteritis viral
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Herpes zoster
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Incision site infection
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Infected bites
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Localised infection
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Lung infection
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Tooth infection
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Tuberculosis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Urosepsis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Vestibular neuronitis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Viral infection
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Head injury
|
1.2%
10/853 • Number of events 11 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.59%
5/853 • Number of events 5 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.59%
5/853 • Number of events 5 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.47%
4/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.47%
4/853 • Number of events 8 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.47%
4/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Laceration
|
0.47%
4/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.35%
3/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.35%
3/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.35%
3/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.35%
3/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.35%
3/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.35%
3/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Accident
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Bursa injury
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Face injury
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Open wound
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Overdose
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Wound
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Investigations
Investigation
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Investigations
Thyroid function test abnormal
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.70%
6/853 • Number of events 6 • From Entry Visit until Last Visit (up to 162 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Metabolism and nutrition disorders
Histamine intolerance
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.82%
7/853 • Number of events 7 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.47%
4/853 • Number of events 5 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Femoroacetabular impingement
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.12%
1/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.47%
4/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.12%
1/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ependymoma
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mixed oligo-astrocytoma
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular neoplasm
|
0.12%
1/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Convulsion
|
4.2%
36/853 • Number of events 54 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Epilepsy
|
1.3%
11/853 • Number of events 13 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Status epilepticus
|
1.2%
10/853 • Number of events 12 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Grand mal convulsion
|
0.94%
8/853 • Number of events 12 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Myoclonus
|
1.1%
9/853 • Number of events 20 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Myoclonic epilepsy
|
0.47%
4/853 • Number of events 11 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Seizure cluster
|
0.47%
4/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Somnolence
|
0.35%
3/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Complex partial seizures
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Headache
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Hypoaesthesia
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Altered state of consciousness
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Ataxia
|
0.12%
1/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Aura
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Balance disorder
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Brachial plexopathy
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Cerebral haematoma
|
0.12%
1/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Cerebral infarction
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Coordination abnormal
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Dizziness
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Dysarthria
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Encephalitis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Hemiplegia
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Hydrocephalus
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Migraine
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Partial seizures
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Presyncope
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Radiculitis lumbosacral
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Status migrainosus
|
0.12%
1/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Toxic encephalopathy
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Tremor
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.47%
4/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion complete
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on oral contraceptive
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Suicidal ideation
|
0.82%
7/853 • Number of events 7 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Depression
|
0.70%
6/853 • Number of events 7 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Psychotic disorder
|
0.35%
3/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Aggression
|
0.35%
3/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Suicide attempt
|
0.35%
3/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Abnormal behaviour
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Acute psychosis
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Anxiety
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Confusional state
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Depressed mood
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Dysthymic disorder
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Suicidal behaviour
|
0.23%
2/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Agitation
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Conversion disorder
|
0.12%
1/853 • Number of events 2 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Decreased interest
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Delirium tremens
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Dissociative disorder
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Insomnia
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Mental disorder
|
0.12%
1/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Panic attack
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Panic disorder
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Polydipsia psychogenic
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Restlessness
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.35%
3/853 • Number of events 6 • From Entry Visit until Last Visit (up to 162 months)
|
|
Renal and urinary disorders
Bladder pain
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Renal and urinary disorders
Calculus bladder
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Renal and urinary disorders
Calculus ureteric
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Renal and urinary disorders
Calculus urinary
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Renal and urinary disorders
Dysuria
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Renal and urinary disorders
Renal failure acute
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.47%
4/853 • Number of events 4 • From Entry Visit until Last Visit (up to 162 months)
|
|
Reproductive system and breast disorders
Epididymitis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.23%
2/853 • Number of events 3 • From Entry Visit until Last Visit (up to 162 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Surgical and medical procedures
Artificial urinary sphincter implant
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Surgical and medical procedures
Cataract operation
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Surgical and medical procedures
Cholecystectomy
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Surgical and medical procedures
Gallbladder operation
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Surgical and medical procedures
Hernia repair
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Surgical and medical procedures
Radiotherapy
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Surgical and medical procedures
Shoulder operation
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Surgical and medical procedures
Tonsillectomy
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Surgical and medical procedures
Tracheostomy
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Surgical and medical procedures
Urethral repair
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Vascular disorders
Circulatory collapse
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Vascular disorders
Haematoma
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Vascular disorders
Hypertension
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Vascular disorders
Hypertensive crisis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
|
Vascular disorders
Venous thrombosis
|
0.12%
1/853 • Number of events 1 • From Entry Visit until Last Visit (up to 162 months)
|
Other adverse events
| Measure |
Brivaracetam (SS)
n=853 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).
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
6.8%
58/853 • Number of events 114 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
78/853 • Number of events 112 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Nausea
|
6.4%
55/853 • Number of events 78 • From Entry Visit until Last Visit (up to 162 months)
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
53/853 • Number of events 89 • From Entry Visit until Last Visit (up to 162 months)
|
|
General disorders
Fatigue
|
9.8%
84/853 • Number of events 106 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Nasopharyngitis
|
18.4%
157/853 • Number of events 332 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Urinary tract infection
|
8.8%
75/853 • Number of events 125 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Influenza
|
7.7%
66/853 • Number of events 104 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
50/853 • Number of events 127 • From Entry Visit until Last Visit (up to 162 months)
|
|
Infections and infestations
Bronchitis
|
5.5%
47/853 • Number of events 68 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Fall
|
5.5%
47/853 • Number of events 62 • From Entry Visit until Last Visit (up to 162 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
45/853 • Number of events 68 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.0%
77/853 • Number of events 99 • From Entry Visit until Last Visit (up to 162 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
52/853 • Number of events 73 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Headache
|
21.8%
186/853 • Number of events 419 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Dizziness
|
14.4%
123/853 • Number of events 191 • From Entry Visit until Last Visit (up to 162 months)
|
|
Nervous system disorders
Convulsion
|
13.1%
112/853 • Number of events 158 • From Entry Visit until Last Visit (up to 162 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Somnolence
|
8.6%
73/853 • Number of events 104 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Insomnia
|
8.3%
71/853 • Number of events 95 • From Entry Visit until Last Visit (up to 162 months)
|
|
Psychiatric disorders
Depression
|
7.6%
65/853 • Number of events 80 • From Entry Visit until Last Visit (up to 162 months)
|
|
Vascular disorders
Hypertension
|
5.0%
43/853 • Number of events 53 • From Entry Visit until Last Visit (up to 162 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60