Trial Outcomes & Findings for This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment (NCT NCT00150800)
NCT ID: NCT00150800
Last Updated: 2021-08-17
Results Overview
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
668 participants
Primary outcome timeframe
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Results posted on
2021-08-17
Participant Flow
The study started to enroll patients in January 2006 and concluded in September 2017. 668 subjects were included in the Enrolled Set but 1 subject from India lost to follow up and was excluded from the Safety Analysis Set due to lack of medical data.
The Participant Flow refers to the Safety Analysis Set which included all subjects who took at least 1 dose of study drug.
Participant milestones
| Measure |
Brivaracetam
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
|
|---|---|
|
Overall Study
STARTED
|
667
|
|
Overall Study
COMPLETED
|
171
|
|
Overall Study
NOT COMPLETED
|
496
|
Reasons for withdrawal
| Measure |
Brivaracetam
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
|
|---|---|
|
Overall Study
Adverse Event
|
89
|
|
Overall Study
Death
|
18
|
|
Overall Study
Lack of Efficacy
|
166
|
|
Overall Study
Lost to Follow-up
|
58
|
|
Overall Study
Subject's choice
|
90
|
|
Overall Study
No compliance
|
18
|
|
Overall Study
IP misshandling
|
1
|
|
Overall Study
Site closure
|
24
|
|
Overall Study
Protocol non-adherence
|
2
|
|
Overall Study
Nobody to accompany patient
|
1
|
|
Overall Study
Distance too long for patient
|
1
|
|
Overall Study
Neurosurgery
|
2
|
|
Overall Study
BRV monotherapy
|
1
|
|
Overall Study
Visit refusal
|
3
|
|
Overall Study
Sponsor's request
|
2
|
|
Overall Study
Generalized Epilepsy
|
1
|
|
Overall Study
Moved from area/country
|
8
|
|
Overall Study
PI retiring
|
2
|
|
Overall Study
PI leaving site
|
2
|
|
Overall Study
Patient insurance
|
1
|
|
Overall Study
Surgical intervention
|
4
|
|
Overall Study
Pregnancy planned
|
1
|
|
Overall Study
PI discontinuation request
|
1
|
Baseline Characteristics
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment
Baseline characteristics by cohort
| Measure |
Brivaracetam
n=667 Participants
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
|
|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
632 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
303 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
364 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
206 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian Or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
361 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)Population: The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Outcome measures
| Measure |
Brivaracetam (SS)
n=667 Participants
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
|
|---|---|
|
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period
|
91.2 percentage of participants
|
PRIMARY outcome
Timeframe: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)Population: The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.
Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Outcome measures
| Measure |
Brivaracetam (SS)
n=667 Participants
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
|
|---|---|
|
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period
|
14.8 percentage of participants
|
PRIMARY outcome
Timeframe: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)Population: The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.
A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.
Outcome measures
| Measure |
Brivaracetam (SS)
n=667 Participants
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
|
|---|---|
|
Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period
|
22.8 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline of the previous study to the Evaluation Period (up to 11 years)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.
Baseline is the Baseline from subject's previous study of enrollment period. N01193 \[NCT00175825\], N01252 \[NCT00490035\], N01253 \[NCT00464269\], N01254 \[NCT00504881\]. A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28.
Outcome measures
| Measure |
Brivaracetam (SS)
n=648 Participants
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
|
|---|---|
|
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
baseline
|
9.2 Seizures per 28 days
Interval 5.5 to 20.2
|
|
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
on treatment
|
4.2 Seizures per 28 days
Interval 1.6 to 11.3
|
SECONDARY outcome
Timeframe: From Baseline of the previous study to the Evaluation Period (up to 11 years)Population: The Partial Onset Seizures (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 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.
Outcome measures
| Measure |
Brivaracetam (SS)
n=648 Participants
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
|
|---|---|
|
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
|
57.3 percent change
Interval 18.6 to 82.2
|
SECONDARY outcome
Timeframe: From Baseline of the previous study to the Evaluation Period (up to 11 years)Population: The Partial Onset Seizures (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.
A responder is defined as a subject with a higher than or equal to (\>=) 50 % change in seizure frequency from Baseline period of the previous study.
Outcome measures
| Measure |
Brivaracetam (SS)
n=648 Participants
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
|
|---|---|
|
Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period
|
55.6 percentage of participants
|
Adverse Events
Brivaracetam
Serious events: 152 serious events
Other events: 521 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Brivaracetam
n=667 participants at risk
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Cardiac disorders
Angina unstable
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Cardiac disorders
Bradycardia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Cardiac disorders
Myocardial infarction
|
0.45%
3/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Cardiac disorders
Myocardial ischaemia
|
0.15%
1/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Ear and labyrinth disorders
Vertigo
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Constipation
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Gastric fistula
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Splenic artery aneurysm
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
General disorders
Chest pain
|
0.30%
2/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
General disorders
Drug ineffective
|
0.15%
1/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
General disorders
Multi-organ failure
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
General disorders
Non-cardiac chest pain
|
0.15%
1/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
General disorders
Pyrexia
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
General disorders
Sudden unexplained death in epilepsy
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
General disorders
Unevaluable event
|
0.45%
3/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Appendicitis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Cellulitis
|
0.30%
2/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Coccidioidomycosis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Dengue fever
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Disseminated tuberculosis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Encephalitis herpes
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Escherichia sepsis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Gastroenteritis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Gastroenteritis viral
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Lobar pneumonia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Lung infection
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Malaria
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Mastoiditis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Meningitis tuberculous
|
0.15%
1/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Neurocysticercosis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Osteomyelitis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Periorbital cellulitis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Pneumonia
|
1.0%
7/667 • Number of events 9 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Pyelonephritis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Rickettsiosis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Sepsis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Tooth abscess
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Urinary tract infection
|
0.45%
3/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Viral infection
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Accident
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.45%
3/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.45%
3/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.45%
3/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.15%
1/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.60%
4/667 • Number of events 4 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.15%
1/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Investigations
Anticonvulsant drug level increased
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Investigations
Weight decreased
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Investigations
Weight increased
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.30%
2/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular neoplasm
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.45%
3/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Ataxia
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Central nervous system lesion
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Cerebral infarction
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.45%
3/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Complicated migraine
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Convulsion
|
2.2%
15/667 • Number of events 20 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Dizziness
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Epilepsy
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Grand mal convulsion
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Headache
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Hemiparesis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Partial seizures
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Postictal state
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Seizure cluster
|
0.15%
1/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Somnolence
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Status epilepticus
|
0.90%
6/667 • Number of events 7 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.60%
4/667 • Number of events 4 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.75%
5/667 • Number of events 5 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on oral contraceptive
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Abnormal behaviour
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Aggression
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Completed suicide
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Depression
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Hallucination
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Major depression
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Paranoia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Psychotic disorder
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Schizophrenia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Self-injurious ideation
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Suicidal ideation
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Suicide attempt
|
1.0%
7/667 • Number of events 8 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Renal and urinary disorders
Calculus ureteric
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Renal and urinary disorders
Calculus urinary
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Renal and urinary disorders
Renal failure
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Renal and urinary disorders
Renal failure acute
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Reproductive system and breast disorders
Scrotal disorder
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.45%
3/667 • Number of events 3 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.15%
1/667 • Number of events 1 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Surgical and medical procedures
Abortion induced
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Vascular disorders
Hypertension
|
0.30%
2/667 • Number of events 2 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
Other adverse events
| Measure |
Brivaracetam
n=667 participants at risk
Brivaracetam (BRV) used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg /day on a weekly basis.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
10.0%
67/667 • Number of events 93 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
65/667 • Number of events 86 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
58/667 • Number of events 109 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Toothache
|
6.3%
42/667 • Number of events 66 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
39/667 • Number of events 55 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Gastrointestinal disorders
Constipation
|
5.7%
38/667 • Number of events 48 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
General disorders
Pyrexia
|
10.3%
69/667 • Number of events 132 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
General disorders
Fatigue
|
7.6%
51/667 • Number of events 63 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
General disorders
Irritability
|
6.3%
42/667 • Number of events 50 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Nasopharyngitis
|
14.1%
94/667 • Number of events 154 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Influenza
|
12.6%
84/667 • Number of events 177 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
11.4%
76/667 • Number of events 137 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Infections and infestations
Urinary tract infection
|
9.6%
64/667 • Number of events 150 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Fall
|
6.0%
40/667 • Number of events 72 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Contusion
|
5.1%
34/667 • Number of events 68 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Injury, poisoning and procedural complications
Laceration
|
5.1%
34/667 • Number of events 65 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.4%
36/667 • Number of events 41 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.6%
64/667 • Number of events 88 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
52/667 • Number of events 66 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
44/667 • Number of events 63 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Headache
|
24.7%
165/667 • Number of events 420 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Dizziness
|
21.3%
142/667 • Number of events 254 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Somnolence
|
13.6%
91/667 • Number of events 116 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Convulsion
|
10.5%
70/667 • Number of events 99 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Nervous system disorders
Tremor
|
5.7%
38/667 • Number of events 48 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Depression
|
10.5%
70/667 • Number of events 85 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Insomnia
|
7.3%
49/667 • Number of events 65 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Psychiatric disorders
Anxiety
|
6.7%
45/667 • Number of events 65 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
46/667 • Number of events 69 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
34/667 • Number of events 56 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
|
Vascular disorders
Hypertension
|
6.9%
46/667 • Number of events 55 • Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60