Trial Comparing the Efficacy and Safety of Lacosamide (LC... | NCT01243177

NCT01243177

ID	Type	Description	Link
2010-019765-28	EudraCT Number

Status Module

Name	Class
Eden Sarl	INDUSTRY

Label	Type	Description	Intervention Names
Lacosamide	Experimental		Drug: Lacosamide
Carbamazepine-Controlled Release (CBZ-CR)	Active Comparator		Drug: Carbamazepine-Controlled Release

Name	Type	Description	Arm Group Labels	Other Names
Lacosamide	Drug	Lacosamide: Strengths: 50 mg / 100 mg Form: tablets Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose Duration: up to 118 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject	The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.	6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject
Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject	The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.	6 consecutive months (26 consecutive weeks) of treatment
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)	An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.	Duration of the Treatment Phase (up to 113 weeks)
Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)	An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject	The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.	12 consecutive months of treatment following stabilization at the last evaluated dose for each subject

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject able to comply with study requirements
Subject is 16 years and older (female; male). Minors will be included in countries only if legally permitted
Subject has newly or recently diagnosed Epilepsy experiencing partial onset seizures (POS) or generalized tonic-clonic seizures with at least 2 unprovoked seizures separated by 48 hours in the 12 months preceding Visit 1 out of which at least 1 seizure occured 3 months preceding Visit 1
Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam of the brain within the past 12 months. If the EEG and brain CT scan or MRI exam were not performed prior to Visit 1, they need to be completed and results must be available prior to randomization at Visit 2

Exclusion Criteria:

Subject has a history or presence of seizures of other types than partial-onset (IA, IB, IC with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures (eg, myoclonic, absence)
Subject has a history or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time (ie, < 20 minutes) with or without function regained between 2 ictal events
Subject has a history, clinical, or Electroencephalogram (EEG) finding suggestive of Idiopathic Generalized Epilepsy (IGE) at randomization
Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures based on expert opinion and/or EEG evidence
Subject has any medical or psychiatric condition
Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
Subject has received treatment with Phenobarbital or Primidone within 28 days prior to Visit 1
Subject is taking Benzodiazepines for a nonepilepsy indication
Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) (including Benzodiazepines) in the last 6 months before Visit. However, acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 3 days prior to randomization
Prior use of Felbamate or Vigabatrin is not allowed
Benzodiazepines as rescue therapy for Epilepsy may have been used as needed in this time period, but not more frequently than once per week
Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion, has a history of alcohol or drug abuse within the previous 2 years
Asian ancestry and tests positive for HLA-B*1502 allele
Asian ancestry and tests positive for HLA-A*3101 allele

Name	Affiliation	Role
UCB Cares	+1 877 822 9493 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
786		Alabaster	Alabama		United States
799

PubMed Identifier	Type	Citation	Retractions
27889312	Result	Baulac M, Rosenow F, Toledo M, Terada K, Li T, De Backer M, Werhahn KJ, Brock M. Efficacy, safety, and tolerability of lacosamide monotherapy versus controlled-release carbamazepine in patients with newly diagnosed epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol. 2017 Jan;16(1):43-54. doi: 10.1016/S1474-4422(16)30292-7. Epub 2016 Nov 24.
33200428

Label	URL
FDA Safety Alerts and Recalls	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lacosamide	Strengths: 50 mg / 100 mg Form: tablets Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose Duration: up to 118 weeks
FG001	Carbamazepine-Controlled Release (CBZ-CR)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject

The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.

Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.

Posted

Number

95% Confidence Interval

percentage of subjects

6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject

ID	Title	Description
OG000	Lacosamide	Strengths: 50 mg / 100 mg Form: tablets Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose Duration: up to 118 weeks
OG001	Carbamazepine-Controlled Release (CBZ-CR)	Strengths: 200 mg Form: tablets Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose Duration: up to 118 weeks

Units	Counts
Participants	OG000444 OG001442

Title

Denominators

Categories

Title	Measurements
	OG00089.8(86.8 to 92.8) OG00191.1(88.2 to 94.0)

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 OG001	This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.	Mantel Haenszel	The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and >2).			Mean Difference (Final Values)	-1.3			2-Sided	95	-5.5	2.8			The lower limit of the confidence interval was >-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was >- 20 %.

Primary

Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject

The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.

The Per Protocol Set (PPS) was defined as containing all subjects in the Full Analysis Set (FAS) who did not have any important protocol deviations determined to impact the interpretation of primary efficacy.

Posted

Number

95% Confidence Interval

percentage of subjects

6 consecutive months (26 consecutive weeks) of treatment

ID	Title	Description
OG000	Lacosamide	Strengths: 50 mg / 100 mg Form: tablets Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose Duration: up to 118 weeks
OG001	Carbamazepine-Controlled Release (CBZ-CR)	Strengths: 200 mg Form: tablets Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose Duration: up to 118 weeks

Primary

Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)

An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.

Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.

Posted

Number

Participants

Duration of the Treatment Phase (up to 113 weeks)

ID	Title	Description
OG000	Lacosamide	Strengths: 50 mg / 100 mg Form: tablets Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose Duration: up to 118 weeks
OG001	Carbamazepine-Controlled Release (CBZ-CR)	Strengths: 200 mg Form: tablets Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose Duration: up to 118 weeks

Primary

Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)

Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.

Posted

Number

Participants

Duration of the Treatment Phase (up to 113 weeks)

ID	Title	Description
OG000	Lacosamide	Strengths: 50 mg / 100 mg Form: tablets Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose Duration: up to 118 weeks
OG001	Carbamazepine-Controlled Release (CBZ-CR)	Strengths: 200 mg Form: tablets Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose Duration: up to 118 weeks

Secondary

Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject

The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.

Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.

Posted

Number

95% Confidence Interval

percentage of subjects

12 consecutive months of treatment following stabilization at the last evaluated dose for each subject

ID	Title	Description
OG000	Lacosamide	Strengths: 50 mg / 100 mg Form: tablets Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose Duration: up to 118 weeks
OG001	Carbamazepine-Controlled Release (CBZ-CR)	Strengths: 200 mg Form: tablets Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose Duration: up to 118 weeks

Units	Counts

Primary

Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)

A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.

Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.

Posted

Number

Participants

Duration of the Treatment Phase (up to 113 weeks)

ID	Title	Description
OG000	Lacosamide	Strengths: 50 mg / 100 mg Form: tablets Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose Duration: up to 118 weeks
OG001	Carbamazepine-Controlled Release (CBZ-CR)

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	Lacosamide	Strengths: 50 mg / 100 mg Form: tablets Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose Duration: up to 118 weeks			36	444	165	444
EG001	Carbamazepine-Controlled Release (CBZ-CR)	Strengths: 200 mg Form: tablets Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose Duration: up to 118 weeks			46	442	181	442

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Antiphospholipid syndrome	Blood and lymphatic system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Aplastic anaemia	Blood and lymphatic system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Atrial fibrillation	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0011 events1 affected442 at risk
Angina pectoris	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Cardiac failure	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Sinus tachycardia	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events1 affected444 at risk EG0010 events0 affected442 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Addison's disease	Endocrine disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Hyperthyroidism	Endocrine disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Gait disturbance	General disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected444 at risk EG0010 events0 affected442 at risk
Oedema peripheral	General disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0011 events1 affected442 at risk
Fatigue	General disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Inflammation	General disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Pyrexia	General disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0011 events1 affected442 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Hypersensitivity	Immune system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Pneumonia	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0011 events1 affected442 at risk
Appendicitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Bronchitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Dengue fever	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Gastroenteritis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Peritonsillar abscess	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Pyelonephritis acute	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Sinusitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Tuberculous pleurisy	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Vestibular neuronitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected444 at risk EG0010 events0 affected442 at risk
Fall	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0011 events1 affected442 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Accident	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0012 events1 affected442 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Smear cervix abnormal	Investigations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Urine albumin/creatinine ratio increased	Investigations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Alanine aminotransferase increased	Investigations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Aspartate aminotransferase increased	Investigations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Acoustic neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Anaplastic astrocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Convulsion	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0004 events4 affected444 at risk EG0013 events2 affected442 at risk
Complex partial seizures	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected444 at risk EG0011 events1 affected442 at risk
Epilepsy	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0003 events2 affected444 at risk EG0010 events0 affected442 at risk
Headache	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0011 events1 affected442 at risk
Dyskinesia	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Motor neurone disease	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Orthostatic intolerance	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Preictal state	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Syncope	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Partial seizures with secondary generalisation	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0013 events3 affected442 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0012 events2 affected442 at risk
Grand mal convulsion	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0012 events2 affected442 at risk
Ischaemic stroke	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0012 events2 affected442 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Trigeminal nerve disorder	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Aggression	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Agitation	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Suicidal ideation	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Suicide attempt	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Dyspnoea paroxysmal nocturnal	Respiratory, thoracic and mediastinal disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected444 at risk EG0010 events0 affected442 at risk
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0012 events2 affected442 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0011 events1 affected442 at risk
Hypertension	Vascular disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected444 at risk EG0012 events1 affected442 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG00032 events26 affected444 at risk EG00130 events23 affected442 at risk
Fatigue	General disorders	MedDRA16.1	Non-systematic Assessment	EG00038 events34 affected444 at risk EG00155 events49 affected442 at risk
Nasopharyngitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG00042 events29 affected444 at risk EG00137 events29 affected442 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA16.1	Non-systematic Assessment	EG0008 events7 affected444 at risk EG00136 events35 affected442 at risk
Headache	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00082 events60 affected444 at risk EG00178 events58 affected442 at risk
Dizziness	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00061 events53 affected444 at risk EG00152 events41 affected442 at risk
Somnolence	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00028 events27 affected444 at risk EG00147 events41 affected442 at risk

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

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

ID	Title	Description
BG000	Lacosamide	Strengths: 50 mg / 100 mg Form: tablets Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose Duration: up to 118 weeks
BG001	Carbamazepine-Controlled Release (CBZ-CR)	Strengths: 200 mg Form: tablets Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose Duration: up to 118 weeks
BG002	Total Title