Brivaracetam Safety and Efficacy Follow-up Study in Subje... | NCT01339559

NCT01339559

ID	Type	Description	Link
2010-020345-27	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Brivaracetam	Experimental	Brivaracetam with a maximum of 200 mg/day	Drug: Brivaracetam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brivaracetam	Drug	Tablet, Flexible dosing up to 200 mg/day, twice daily. The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)	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.	From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Percentage of Participants Who Withdrew Due to Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.	From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Percentage of Participants With at Least One Serious Adverse Event (SAE)	A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Is as infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.	From Entry Visit (Month 0) until the Last Visit (up to 84 months)

Secondary Outcomes

Measure	Description	Time Frame
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days 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.	From Baseline of the previous study until the Last Visit (up to 84 months)

Eligibility Module

Name	Affiliation	Role
UCB Cares	+1 844 599 2273 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
001		Phoenix	Arizona	85004	United States
013

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34218211	Result	Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.
36435010

Label	URL
Product Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 15, 2015	Apr 7, 2020

Arm/Group Information

ID	Title	Description
BG000	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.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG00019
Between 18 and 65 years	BG000722
>=65 years	BG000

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00040.0± 12.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000396
Male	BG000370

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG000561
African-American	BG00037

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

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.

The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug.

Posted

Number

Percentage of participants

From Entry Visit (Month 0) until the Last Visit (up to 84 months)

ID	Title	Description
OG000	Brivaracetam (SS)	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).

Units	Counts
Participants	OG000766

Title

Denominators

Categories

Title	Measurements
	OG00083.9

Primary

Percentage of Participants Who Withdrew Due to Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug.

Posted

Number

Percentage of participants

From Entry Visit (Month 0) until the Last Visit (up to 84 months)

ID	Title	Description
OG000	Brivaracetam (SS)	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).

Units	Counts
Participants	OG000

Primary

Percentage of Participants With at Least One Serious Adverse Event (SAE)

A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

Results in death
Is life-threatening
Requires in patient hospitalization or prolongation of existing hospitalization
Is a congenital anomaly or birth defect
Is as infection that requires treatment parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.

The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug.

Posted

Number

Percentage of participants

From Entry Visit (Month 0) until the Last Visit (up to 84 months)

ID	Title	Description
OG000	Brivaracetam (SS)	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).

Units	Counts
Participants

Secondary

Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days 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.

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.

Posted

Median

Inter-Quartile Range

Seizures per 28 days

From Baseline of the previous study until the Last Visit (up to 84 months)

ID	Title	Description
OG000	Brivaracetam (POS Efficacy)	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 Partial Onset Seizure Efficacy Set (POS Efficacy).

Units	Counts
Participants	OG000

Secondary

Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to 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.

Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of percent change in POS frequency.

The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.

Participants from N01258 were excluded from this analysis.

Posted

Median

Inter-Quartile Range

Percent change

From Baseline of the previous study until the Last Visit (up to 84 months)

ID	Title	Description
OG000	Brivaracetam (POS Efficacy)	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 Partial Onset Seizure Efficacy Set (POS Efficacy).

Secondary

Responder Rate in POS (Type I) Frequency Over the Evaluation Period

A responder is defined as a subject with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study.

The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.

Participants from N01258 were excluded from this analysis.

Posted

Number

Percentage of participants

From Baseline of the previous study until the Last Visit (up to 84 months)

ID	Title	Description
OG000	Brivaracetam (POS Efficacy)	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 Partial Onset Seizure Efficacy Set (POS Efficacy).

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Brivaracetam (SS)	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).	5	766	140	766	421	766

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Hypoplastic anaemia	Blood and lymphatic system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Cardiac arrest	Cardiac disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Cardiac failure	Cardiac disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Myocardial infarction	Cardiac disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Angina pectoris	Cardiac disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Sickle cell anaemia	Congenital, familial and genetic disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Goitre	Endocrine disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Diplopia	Eye disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Vomiting	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Dysphagia	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Gastritis	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Oesophageal perforation	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Pyrexia	General disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Asthenia	General disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Device malfunction	General disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events1 affected766 at risk
Non-cardiac chest pain	General disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA15.0	Non-systematic Assessment	EG0003 events3 affected766 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Pneumonia	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0005 events5 affected766 at risk
Sepsis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Appendicitis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Appendicitis perforated	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Diverticulitis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Gastroenteritis escherichia coli	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Infected cyst	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Infection	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Osteomyelitis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Otitis media chronic	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Perineal abscess	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Pharyngitis bacterial	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Typhoid fever	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Urinary tract infection	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Wound infection	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0004 events3 affected766 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Fall	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Nail injury	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Spinal cord injury cervical	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Diagnostic procedure	Investigations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Transaminases increased	Investigations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Troponin increased	Investigations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Weight decreased	Investigations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA15.0	Non-systematic Assessment	EG0003 events3 affected766 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Gliomatosis cerebri	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Thymoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Convulsion	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG00016 events15 affected766 at risk
Status epilepticus	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG00011 events11 affected766 at risk
Epilepsy	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0007 events7 affected766 at risk
Seizure cluster	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0004 events4 affected766 at risk
Headache	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Ischaemic stroke	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Partial seizures with secondary generalisation	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Ataxia	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Balance disorder	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Cerebellar syndrome	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Cervical cord compression	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Complex partial seizures	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Encephalitis	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Grand mal convulsion	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Hemiparesis	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Hydrocephalus	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Loss of consciousness	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Myelopathy	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Polyneuropathy	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Radiculopathy	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Simple partial seizures	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Somnolence	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Imminent abortion	Pregnancy, puerperium and perinatal conditions	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Suicide attempt	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0007 events7 affected766 at risk
Suicidal ideation	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0005 events5 affected766 at risk
Acute psychosis	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Depression	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Aggression	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Anxiety	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Anxiety disorder	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Confusional state	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Delirium	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0003 events1 affected766 at risk
Delirium febrile	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Emotional disorder	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Renal colic	Renal and urinary disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected766 at risk
Menometrorrhagia	Reproductive system and breast disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Spermatic cord haemorrhage	Reproductive system and breast disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Intervertebral disc operation	Surgical and medical procedures	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk
Tenodesis	Surgical and medical procedures	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected766 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA15.0	Non-systematic Assessment	EG00067 events59 affected766 at risk
Nasopharyngitis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG000102 events65 affected766 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG000101 events59 affected766 at risk
Urinary tract infection	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG00086 events57 affected766 at risk
Influenza	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG00047 events40 affected766 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG00071 events44 affected766 at risk
Fall	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG00060 events43 affected766 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG00059 events46 affected766 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG00056 events41 affected766 at risk
Headache	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG000187 events102 affected766 at risk
Dizziness	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG000123 events100 affected766 at risk
Somnolence	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG00088 events73 affected766 at risk
Depression	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG00053 events45 affected766 at risk
Anxiety	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG00048 events42 affected766 at risk

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases