Trial to Demonstrate the Efficacy and Safety of Conversio... | NCT00520741

ID	Type	Description	Link
2007-005439-27	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

Label	Type	Description	Intervention Names
Lacosamide 400 mg/day	Experimental	Lacosamide 400 mg/day	Drug: Lacosamide
Lacosamide 300 mg/day	Active Comparator	Lacosamide 300 mg/day	Drug: Lacosamide

Name	Type	Description	Arm Group Labels	Other Names
Lacosamide	Drug	50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.	Lacosamide 400 mg/day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)	Pre-defined exit criteria: A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase. Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation Status epilepticus, or new onset of serial/cluster seizures	16 Weeks Maintenance Period (approximately 112 days)

Secondary Outcomes

Measure	Description	Time Frame
Time to First Occurrence of Any Exit Event During The Maintenance Period	The time to first occurrence (days) of any exit event was estimated using Kaplan-Meier methods and was based on the time from the start of the Maintenance Phase to the earliest date a subject met an exit criterion. Subjects who discontinued during the Maintenance Phase due to non-exit criteria reasons or who completed the Maintenance Phase before 112 days and did not meet an exit criterion were censored as of the last Maintenance Phase dose date. Subjects completing 112 days in the Maintenance Phase were censored as of Day 112.

Eligibility Module

Name	Affiliation	Role
UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
48		Alabaster	Alabama		United States
10

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24915838	Derived	Wechsler RT, Li G, French J, O'Brien TJ, D'Cruz O, Williams P, Goodson R, Brock M; ALEX-MT Study Group. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014 Jul;55(7):1088-98. doi: 10.1111/epi.12681. Epub 2014 Jun 10.

Label	URL
FDA safety Alerts and Recalls	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lacosamide 300 mg/Day	Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Lacosamide 300 mg/Day	Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
BG001	Lacosamide 400 mg/Day	Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
BG002	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, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0003 BG0017 BG00210
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00041.4± 14.3 BG00140.4± 12.5 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00050 BG001169 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG00091 BG001246 BG002

Height

Mean

Standard Deviation

centimeter

Title

Denominators

Categories

Title	Measurements
	BG000169.72± 10.69 BG001169.01± 10.87 BG002

Weight

Mean

Standard Deviation

kilogram

Title

Denominators

Categories

Title	Measurements
	BG00081.62± 19.53 BG00182.13± 21.30 BG002

Body Mass Index (BMI)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00028.22± 5.74 BG00128.67± 6.64 BG002

Average Baseline Seizure Frequency per 28 days

Mean

Standard Deviation

seizures/28 days

Title

Denominators

Categories

Title	Measurements
	BG00010.10± 8.82 BG00110.22± 8.88 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

Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)

Pre-defined exit criteria:

A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase
A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase.

Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion
Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization
A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation
Status epilepticus, or new onset of serial/cluster seizures

The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (ie, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).

The primary analysis is only conducted on the Lacosamide 400 mg/day group.

Posted

Number

percentage of subjects

16 Weeks Maintenance Period (approximately 112 days)

ID	Title	Description
OG000	Lacosamide 300 mg/Day	Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
OG001	Lacosamide 400 mg/Day	Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure.

Units	Counts
Participants	OG0000 OG001284

Title

Denominators

Categories

Title	Measurements
	OG00130.0

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
OG001	The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the lower bound of the 95 % prediction interval for the historical-control of 0.653; hereafter referred to as the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.	Kaplan-Meier	Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.			Predicted exit rate at 112 days	0.300			2-Sided	95	0.246	0.355

Secondary

Time to First Occurrence of Any Exit Event During The Maintenance Period

The time to first occurrence (days) of any exit event was estimated using Kaplan-Meier methods and was based on the time from the start of the Maintenance Phase to the earliest date a subject met an exit criterion. Subjects who discontinued during the Maintenance Phase due to non-exit criteria reasons or who completed the Maintenance Phase before 112 days and did not meet an exit criterion were censored as of the last Maintenance Phase dose date. Subjects completing 112 days in the Maintenance Phase were censored as of Day 112.

The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs). In addition to being a member of FAS, subjects also met at least one of the exit criterion noted under the Primary Outcome Measure.

Posted

Median

Full Range

days

16 Weeks Maintenance Period (approximately 112 days)

ID	Title	Description
OG000	Lacosamide 300 mg/Day	Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
OG001	Lacosamide 400 mg/Day	Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.

Secondary

Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period

Subjects were classified as having an exit event if they experienced at least 1 of the following events during the Maintenance Phase as of Day 112:

Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis
Withdrawal due to AE with onset during the Maintenance Phase
Withdrew prematurely due to lack of efficacy during the Maintenance Phase

The date the subject experienced the event was set to the earliest date the subject met an exit criterion or the date of the last Maintenance Phase dose for subjects not meeting an exit criterion but withdrawing due to an AE or lack of efficacy.

The secondary analysis is only conducted on the Lacosamide 400 mg/day group.

The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).

Posted

Number

percentage of subjects

16 Weeks Maintenance Period (approximately 112 days)

ID	Title	Description
OG000	Lacosamide 300 mg/Day	Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.

Secondary

Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)

Days on Monotherapy Treatment were defined as the number of days during the Monotherapy Phase when the subject took Lacosamide (LCM) only (ie, the total number of days exposed to LCM during the Monotherapy Phase minus any days where a concomitant or rescue Anti-epileptic Drug (AED) was taken by the subject). The days on Monotherapy Treatment did not need to be consecutive.

The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs).This subset of the FAS included subjects who entered the Maintenance Phase but who never achieved Lacosamide (LCM) monotherapy.

Posted

Median

Full Range

days

Visit 9 - Visit 12 (approximately 10 weeks)

ID	Title	Description
OG000	Lacosamide 300 mg/Day	Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
OG001	Lacosamide 400 mg/Day	Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.

Secondary

Clinical Global Impression of Change (CGIC) From Baseline To Last Visit

For the assessment of the Clinical Global Impression of Change (CGIC), the investigator should provide his/her assessment of the subject's clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status. He was asked the following:Please check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:

Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse

The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).

Posted

Number

participants

Baseline; Last Visit (approximately 27 weeks)

ID	Title	Description
OG000	Lacosamide 300 mg/Day	Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
OG001	Lacosamide 400 mg/Day	Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.

Secondary

Patient's Global Impression of Change (PGIC) From Baseline To Last Visit

For the assessment of the Patient's Global Impression of Change, the subject should provide his/her assessment of his/her own clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.The subject was asked to answer the following:

Over the past 4 weeks, how have you felt compared to before you entered this clinical trial? (Please check the number that best describes your condition.)

Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse

The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).

Posted

Number

participants

Baseline; Last Visit (approximately 27 weeks)

ID	Title	Description
OG000	Lacosamide 300 mg/Day	Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
OG001	Lacosamide 400 mg/Day	Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.

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 300 mg/Day	Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.			4	106	74	106
EG001	Lacosamide 400 mg/Day	Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.			21	319	215	319

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Glossitis	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Sudden unexplained death in epilepsy	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected319 at risk
Hypersensitivity	Immune system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Polytraumatism	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected319 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Convulsion	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected106 at risk EG0016 events6 affected319 at risk
Epilepsy	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Headache	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Status epilepticus	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Toxic induced encephalopathy	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Conversion disorder	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected319 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected319 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected319 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected319 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0012 events1 affected319 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected319 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vision blurred	Eye disorders	MedDRA 9.1	Non-systematic Assessment	EG0006 events6 affected106 at risk EG00125 events19 affected319 at risk
Nausea	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG00016 events13 affected106 at risk EG00157 events46 affected319 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0009 events7 affected106 at risk EG00122 events21 affected319 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected106 at risk EG00127 events23 affected319 at risk
Fatigue	General disorders	MedDRA 9.1	Non-systematic Assessment	EG00014 events12 affected106 at risk EG00137 events32 affected319 at risk
Nasopharyngitis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0008 events7 affected106 at risk EG00130 events28 affected319 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0006 events5 affected106 at risk EG00119 events16 affected319 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0009 events9 affected106 at risk EG00113 events11 affected319 at risk
Dizziness	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG00026 events19 affected106 at risk EG001121 events86 affected319 at risk
Headache	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG00032 events21 affected106 at risk EG00158 events45 affected319 at risk
Convulsion	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG00022 events17 affected106 at risk EG00136 events29 affected319 at risk
Somnolence	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG00019 events15 affected106 at risk EG00135 events29 affected319 at risk
Tremor	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0008 events8 affected106 at risk EG00123 events23 affected319 at risk
Cognitive disorder	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0008 events7 affected106 at risk EG0016 events6 affected319 at risk
Insomnia	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG00010 events8 affected106 at risk EG00117 events17 affected319 at risk
Anxiety	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0008 events7 affected106 at risk EG00113 events11 affected319 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0005 events4 affected106 at risk EG00120 events16 affected319 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