This Trial, Evaluating the Long-term Safety and Tolerabil... | NCT00150800

NCT00150800

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brivaracetam	Experimental	Brivaracetam 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.	Drug: Brivaracetam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brivaracetam	Drug	Active Substance: Brivaracetam Pharmaceutical Form: Tablet Concentration: 10 mg and 25 mg Route of Administration: Oral	Brivaracetam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period	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.	Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period	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.	Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period	A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.	Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)

Secondary Outcomes

Measure	Description	Time Frame
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days 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.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
N01199 1051		Phoenix	Arizona		United States
N01199 1362

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32221987	Result	O'Brien TJ, Borghs S, He QJ, Schulz AL, Yates S, Biton V. Long-term safety, efficacy, and quality of life outcomes with adjunctive brivaracetam treatment at individualized doses in patients with epilepsy: An up to 11-year, open-label, follow-up trial. Epilepsia. 2020 Apr;61(4):636-646. doi: 10.1111/epi.16484. Epub 2020 Mar 28.
34218211

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

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	Oct 15, 2015	Sep 18, 2018

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	BG00030
Between 18 and 65 years	BG000632
>=65 years	BG000

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00034.3± 12.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000303
Male	BG000364

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian/Alaskan Native	BG00021
Asian	BG000206

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) During the Study Period

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.

The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.

Posted

Number

percentage of participants

Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)

ID	Title	Description
OG000	Brivaracetam (SS)	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.

Units	Counts
Participants	OG000667

Title

Denominators

Categories

Title	Measurements
	OG00091.2

Primary

Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period

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.

The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.

Posted

Number

percentage of participants

Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)

ID	Title	Description
OG000	Brivaracetam (SS)	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.

Units	Counts
Participants	OG000

Primary

Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period

A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.

The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.

Posted

Number

percentage of participants

Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)

ID	Title	Description
OG000	Brivaracetam (SS)	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.

Units	Counts
Participants	OG000

Secondary

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

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 to the Evaluation Period (up to 11 years)

ID	Title	Description
OG000	Brivaracetam (POS-ES)	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.

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.

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.

Posted

Median

Inter-Quartile Range

percent change

From Baseline of the previous study to the Evaluation Period (up to 11 years)

ID	Title	Description
OG000	Brivaracetam (POS-ES)	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.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over 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.

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.

Posted

Number

percentage of participants

From Baseline of the previous study to the Evaluation Period (up to 11 years)

ID	Title	Description
OG000	Brivaracetam (POS-ES)	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.

Units	Counts
Participants	OG000

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	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.	18	667	152	667	521	667

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Angina unstable	Cardiac disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Bradycardia	Cardiac disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Myocardial infarction	Cardiac disorders	MedDRA15.0	Non-systematic Assessment	EG0003 events3 affected667 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events1 affected667 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Vertigo	Ear and labyrinth disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Constipation	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Gastric fistula	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Splenic artery aneurysm	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Vomiting	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Chest pain	General disorders	MedDRA15.0	Non-systematic Assessment	EG0003 events2 affected667 at risk
Drug ineffective	General disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events1 affected667 at risk
Multi-organ failure	General disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Non-cardiac chest pain	General disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events1 affected667 at risk
Pyrexia	General disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Sudden unexplained death in epilepsy	General disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Unevaluable event	General disorders	MedDRA15.0	Non-systematic Assessment	EG0003 events3 affected667 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Appendicitis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Cellulitis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0003 events2 affected667 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Coccidioidomycosis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Dengue fever	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Encephalitis herpes	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Escherichia sepsis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Gastroenteritis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Gastroenteritis viral	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Lobar pneumonia	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Lung infection	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Malaria	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Mastoiditis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Meningitis tuberculous	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0003 events1 affected667 at risk
Neurocysticercosis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Osteomyelitis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Pelvic inflammatory disease	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Periorbital cellulitis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Pneumonia	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0009 events7 affected667 at risk
Pyelonephritis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Rickettsiosis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Sepsis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Tooth abscess	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Urinary tract infection	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0003 events3 affected667 at risk
Viral infection	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Accident	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Anastomotic ulcer	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0003 events3 affected667 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0003 events3 affected667 at risk
Fall	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0003 events3 affected667 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0002 events1 affected667 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0004 events4 affected667 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0002 events1 affected667 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Anticonvulsant drug level increased	Investigations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Weight decreased	Investigations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Weight increased	Investigations	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA15.0	Non-systematic Assessment	EG0003 events2 affected667 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Ocular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Ovarian germ cell teratoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Small intestine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA15.0	Non-systematic Assessment	EG0003 events3 affected667 at risk
Ataxia	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Central nervous system lesion	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Cerebral infarction	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0003 events3 affected667 at risk
Complicated migraine	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Convulsion	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG00020 events15 affected667 at risk
Dizziness	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Epilepsy	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Grand mal convulsion	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Headache	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Hemiparesis	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Partial seizures	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Postictal state	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Seizure cluster	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events1 affected667 at risk
Somnolence	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Status epilepticus	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0007 events6 affected667 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG0004 events4 affected667 at risk
Abortion	Pregnancy, puerperium and perinatal conditions	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Foetal death	Pregnancy, puerperium and perinatal conditions	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA15.0	Non-systematic Assessment	EG0005 events5 affected667 at risk
Pregnancy on contraceptive	Pregnancy, puerperium and perinatal conditions	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Pregnancy on oral contraceptive	Pregnancy, puerperium and perinatal conditions	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Unintended pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Aggression	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Completed suicide	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Depression	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Hallucination	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Major depression	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Paranoia	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Psychotic disorder	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Schizophrenia	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Self-injurious ideation	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Suicidal ideation	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Suicide attempt	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG0008 events7 affected667 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Calculus urinary	Renal and urinary disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Renal failure	Renal and urinary disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Renal failure acute	Renal and urinary disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Scrotal disorder	Reproductive system and breast disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0003 events3 affected667 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0001 events1 affected667 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Abortion induced	Surgical and medical procedures	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk
Hypertension	Vascular disorders	MedDRA15.0	Non-systematic Assessment	EG0002 events2 affected667 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG00093 events67 affected667 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG00086 events65 affected667 at risk
Vomiting	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG000109 events58 affected667 at risk
Toothache	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG00066 events42 affected667 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG00055 events39 affected667 at risk
Constipation	Gastrointestinal disorders	MedDRA15.0	Non-systematic Assessment	EG00048 events38 affected667 at risk
Pyrexia	General disorders	MedDRA15.0	Non-systematic Assessment	EG000132 events69 affected667 at risk
Fatigue	General disorders	MedDRA15.0	Non-systematic Assessment	EG00063 events51 affected667 at risk
Irritability	General disorders	MedDRA15.0	Non-systematic Assessment	EG00050 events42 affected667 at risk
Nasopharyngitis	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG000154 events94 affected667 at risk
Influenza	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG000177 events84 affected667 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG000137 events76 affected667 at risk
Urinary tract infection	Infections and infestations	MedDRA15.0	Non-systematic Assessment	EG000150 events64 affected667 at risk
Fall	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG00072 events40 affected667 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG00068 events34 affected667 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA15.0	Non-systematic Assessment	EG00065 events34 affected667 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA15.0	Non-systematic Assessment	EG00041 events36 affected667 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG00088 events64 affected667 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA15.0	Non-systematic Assessment	EG00066 events52 affected667 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA15.0	Systematic Assessment	EG00063 events44 affected667 at risk
Headache	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG000420 events165 affected667 at risk
Dizziness	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG000254 events142 affected667 at risk
Somnolence	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG000116 events91 affected667 at risk
Convulsion	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG00099 events70 affected667 at risk
Tremor	Nervous system disorders	MedDRA15.0	Non-systematic Assessment	EG00048 events38 affected667 at risk
Depression	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG00085 events70 affected667 at risk
Insomnia	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG00065 events49 affected667 at risk
Anxiety	Psychiatric disorders	MedDRA15.0	Non-systematic Assessment	EG00065 events45 affected667 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA15.0	Non-systematic Assessment	EG00069 events46 affected667 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA15.0	Non-systematic Assessment	EG00056 events34 affected667 at risk
Hypertension	Vascular disorders	MedDRA15.0	Non-systematic Assessment	EG00055 events46 affected667 at risk

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