A Safety, Efficacy and Tolerability Trial of Pregabalin a... | NCT01747915

NCT01747915

ID	Type	Description	Link
2010-023263-18	EudraCT Number

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	Intervention Names
Study Drug Level 1	Experimental	Drug: Pregabalin Dose Level 1
Study Drug Level 2	Experimental	Drug: Pregabalin Dose Level 2
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin Dose Level 1	Drug	Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase	All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).	Day 1 up to Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase	Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28.

Eligibility Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Axcess Medical Research		Loxahatchee Groves	Florida	33470	United States
Pediatric Epilepsy Center of Central Florida

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34033265	Derived	Driscoll J, Almas M, Gregorian G, Kyrychenko A, Makedonska I, Liu J, Patrick J, Scavone JM, Antinew J; 1105 Study Group. Pregabalin as adjunctive therapy in adult and pediatric patients with generalized tonic-clonic seizures: A randomized, placebo-controlled trial. Epilepsia Open. 2021 Jun;6(2):381-393. doi: 10.1002/epi4.12492. Epub 2021 May 16.

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day	Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.

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
SAP	No	Yes	No	Statistical Analysis Plan	Jul 31, 2019	Aug 8, 2019

Arm/Group Information

ID	Title	Description
BG000	Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day	Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
BG001	Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day	Participants aged <17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Participants aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
BG002	Placebo	Participants aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg participants; in the form of capsule or liquid oral solution for >=30 kg participants). Participants aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00024.0± 13.3 BG00125.4± 12.7 BG00226.2± 13.2 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00042 BG00139 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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

Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase

All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).

ITT population included all randomized participants who took at least 1 dose of investigational product during the double-blind treatment phase, have a baseline value and at least 1 post-baseline efficacy assessment.

Posted

Least Squares Mean

Standard Error

Seizure per 28 days

Day 1 up to Week 12

ID	Title	Description
OG000	Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day	Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
OG001	Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day	Participants aged <17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Participants aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.
OG002	Placebo	Participants aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg participants; in the form of capsule or liquid oral solution for >=30 kg participants). Participants aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.

Units	Counts
Participants	OG00075 OG00172 OG00272

Title

Denominators

Categories

Title	Measurements
	OG0001.17± 0.097 OG0011.13± 0.095 OG0021.14± 0.098

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.	ANCOVA		0.8121		Least Square (LS) Mean Difference	0.02	Standard Error of the Mean	0.088	2-Sided	95	-0.15	0.19					Superiority
OG001 OG002

Secondary

Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase

Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28.

Posted

Number

percentage of participants

Day 1 up to Week 12

ID	Title	Description
OG000	Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day	Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.

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	Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day	Participants aged less than (<) 17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight greater than or equal to (>=)30 kg: Pregabalin 5 milligram per kilogram per day (mg/kg/day) as capsule or oral solution (using oral solution of strength 20 milligram per milliliter [mg/mL]), up to a maximum of 300 milligram per day (mg/day); 2) body weight <30 kg: pregabalin 7 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 300 mg/day. Participants aged >=17 years received Pregabalin 300 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.	0	75	2	75	39	75
EG001	Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day	Participants aged <17 years received Pregabalin, orally, twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks in following manner: 1) body weight >=30 kg: Pregabalin 10 mg/kg/day as capsule or oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day; 2) body weight <30 kg: pregabalin 14 mg/kg/day as oral solution (using oral solution of strength 20 mg/mL), up to a maximum of 600 mg/day. Participants aged >=17 years received Pregabalin 600 mg/day, capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks.	0	72	2	72	41	72
EG002	Placebo	Participants aged <17 years received placebo matched to Pregabalin, orally, twice daily for the double-blind treatment phase of 12 weeks (in the form of solution for <30 kg participants; in the form of capsule or liquid oral solution for >=30 kg participants). Participants aged >=17 years received placebo matched to Pregabalin, in the form of capsule or liquid oral solution, orally, twice daily for the double-blind treatment phase of 12 weeks.	1	72	3	72	36	72

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sudden unexplained death in epilepsy	General disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0012 affected72 at risk EG0020 affected72 at risk
Seizure	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0022 affected72 at risk
Status epilepticus	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Eosinophilia	Blood and lymphatic system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0003 affected75 at risk EG0012 affected72 at risk EG0021 affected72 at risk
Diplopia	Eye disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0011 affected72 at risk EG0021 affected72 at risk
Eye disorder	Eye disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Eye irritation	Eye disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Eye pain	Eye disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Vision blurred	Eye disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Visual impairment	Eye disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Constipation	Gastrointestinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Dental caries	Gastrointestinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0011 affected72 at risk EG0021 affected72 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Flatulence	Gastrointestinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Gastritis	Gastrointestinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Nausea	Gastrointestinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0002 affected75 at risk EG0012 affected72 at risk EG0021 affected72 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Toothache	Gastrointestinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0021 affected72 at risk
Vomiting	Gastrointestinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Fatigue	General disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0005 affected75 at risk EG0013 affected72 at risk EG0023 affected72 at risk
Influenza like illness	General disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Pyrexia	General disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0022 affected72 at risk
Sluggishness	General disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Therapeutic response unexpected	General disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Bronchitis	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Diarrhoea infectious	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Helicobacter infection	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Influenza	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Nasopharyngitis	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0012 affected72 at risk EG0021 affected72 at risk
Otitis media acute	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Pharyngitis	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Pneumonia	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Rhinitis	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Tonsillitis	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0004 affected75 at risk EG0012 affected72 at risk EG0024 affected72 at risk
Urinary tract infection	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0002 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Viral infection	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Viral rhinitis	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0012 affected72 at risk EG0023 affected72 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Alanine aminotransferase increased	Investigations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Blood glucose increased	Investigations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Blood pressure increased	Investigations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Platelet count increased	Investigations	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Weight increased	Investigations	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0017 affected72 at risk EG0020 affected72 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0023 affected72 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0002 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Metatarsalgia	Musculoskeletal and connective tissue disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Ataxia	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Disturbance in attention	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0021 affected72 at risk
Dizziness	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG00013 affected75 at risk EG00112 affected72 at risk EG0025 affected72 at risk
Dysgraphia	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Epilepsy	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Head titubation	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Headache	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0007 affected75 at risk EG00111 affected72 at risk EG00212 affected72 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Hypokinesia	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Memory impairment	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Myoclonic epilepsy	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Nystagmus	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Poor quality sleep	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Sedation	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Seizure	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Somnolence	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0005 affected75 at risk EG00111 affected72 at risk EG0027 affected72 at risk
Tremor	Nervous system disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0012 affected72 at risk EG0021 affected72 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Agitation	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Anxiety	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Anxiety disorder	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Apathy	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Bradyphrenia	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0012 affected72 at risk EG0020 affected72 at risk
Confusional state	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Depressed mood	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Enuresis	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Epileptic psychosis	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Insomnia	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Irritability	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0002 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Mood swings	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Soliloquy	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Thinking abnormal	Psychiatric disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Haematuria	Renal and urinary disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Leukocyturia	Renal and urinary disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Proteinuria	Renal and urinary disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Cervical polyp	Reproductive system and breast disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0020 affected72 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Haematoma	Vascular disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Thrombosis	Vascular disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0011 affected72 at risk EG0020 affected72 at risk
Lymphocyte morphology abnormal	Investigations	MedDRA (v21.1)	Non-systematic Assessment	EG0000 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (v21.1)	Non-systematic Assessment	EG0001 affected75 at risk EG0010 affected72 at risk EG0021 affected72 at risk

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001927	Brain Diseases
D002493	Central Nervous System Diseases