Study to Evaluate the Safety, Tolerability, and Efficacy... | NCT01832038

Status Module

Name	Class
UCB Japan Co. Ltd.	INDUSTRY

Arms/Interventions Module

Label	Type	Description	Intervention Names
Lacosamide	Experimental	Lacosamide treatment of 100 - 400 mg/day for long-term	Drug: Lacosamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lacosamide	Drug	Strength: Lacosamide (LCM) 50 mg, LCM 100 mg Formulation: Tablet Frequency: twice daily during the study period (until the date of approval) At the completion of EP0008 [NCT01710657], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could 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.	From Visit 1 (Week 0) up to approximately Week 323
Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the participants from the study. An AE could 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.	From Visit 1 (Week 0) up to approximately Week 323

Secondary Outcomes

Measure	Description	Time Frame
Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009	The percent change from Baseline to the Treatment Period was calculated as {[(Seizure frequency per 28 days during the Treatment Period) minus (Seizure frequency per 28 days during Baseline Period)] divided by (Seizure frequency per 28 days during Baseline Period)} multiplied by 100. Baseline was defined as the Baseline Period of study EP0008 [NCT01710657].

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

PubMed Identifier	Type	Citation	Retractions
34246118	Result	Inoue Y, Liao W, Wang X, Du X, Tennigkeit F, Sasamoto H, Osakabe T, Hoshii N, Yuen N, Hong Z. Safety and efficacy of adjunctive lacosamide in Chinese and Japanese adults with epilepsy and focal seizures: A long-term, open-label extension of a randomized, controlled trial. Epilepsy Res. 2021 Oct;176:106705. doi: 10.1016/j.eplepsyres.2021.106705. Epub 2021 Jun 29.

Label	URL
FDA Safety Alerts and Recalls	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lacosamide	At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day lacosamide (LCM). The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 13, 2013	Jun 15, 2020

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

Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could 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.

The Safety Set (SS) included all enrolled participants in EP0009 who took at least 1 dose of LCM in EP0009.

Posted

Count of Participants

Participants

From Visit 1 (Week 0) up to approximately Week 323

ID	Title	Description
OG000	Lacosamide (SS)	At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Safety Set (SS).

Units	Counts
Participants	OG000473

Title

Denominators

Categories

Title	Measurements
	OG000410

Primary

Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the participants from the study. An AE could 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.

The Safety Set (SS) included all enrolled participants in EP0009 who took at least 1 dose of LCM in EP0009.

Posted

Count of Participants

Participants

From Visit 1 (Week 0) up to approximately Week 323

ID	Title	Description
OG000	Lacosamide (SS)	At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Safety Set (SS).

Units	Counts
Participants

Secondary

Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009

The percent change from Baseline to the Treatment Period was calculated as {[(Seizure frequency per 28 days during the Treatment Period) minus (Seizure frequency per 28 days during Baseline Period)] divided by (Seizure frequency per 28 days during Baseline Period)} multiplied by 100. Baseline was defined as the Baseline Period of study EP0008 [NCT01710657].

The Full Analysis Set (FAS) included all study participants from the SS who had at least 1 day with available seizure diary data in study EP0009.

Posted

Mean

Standard Deviation

Percent change

From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009

ID	Title	Description
OG000	Lacosamide (FAS)	At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Full Analysis Set (FAS).

Units	Counts
Participants

Secondary

Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009

A responder is a subject experiencing a greater than or equal to (≥) 50 % reduction in partial-onset seizure frequency per 28 days from baseline. Baseline was defined as the Baseline Period of study EP0008 [NCT01710657].

The Full Analysis Set (FAS) included all study participants from the SS who had at least 1 day with available seizure diary data in study EP0009.

Posted

Number

percentage of participants

From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009

ID	Title	Description
OG000	Lacosamide (FAS)	At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Full Analysis Set (FAS).

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sinus bradycardia	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Hamartoma	Congenital, familial and genetic disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Blindness unilateral	Eye disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Duodenitis	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Gastritis	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected473 at risk
Gastritis atrophic	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events1 affected473 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Hypertrophic anal papilla	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Pyrexia	General disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Sudden death	General disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Bacterial prostatitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Chronic sinusitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected473 at risk
Encephalitis viral	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Erysipelas	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Gastroenteritis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Lung infection	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Orchitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Peritonitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Peritonsillar abscess	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Pneumonia	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0006 events6 affected473 at risk
Retroperitoneal infection	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Tuberculosis of genitourinary system	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0003 events2 affected473 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected473 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0003 events2 affected473 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0003 events1 affected473 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Injury	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected473 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected473 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0002 events1 affected473 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events1 affected473 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Meigs' syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Metastatic glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Ovarian fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Ovarian germ cell teratoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Cerebral infarction	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected473 at risk
Complex partial seizures	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Convulsion	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0003 events3 affected473 at risk
Epilepsy	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00010 events10 affected473 at risk
Grand mal convulsion	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Headache	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Intracranial haematoma	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Partial seizures with secondary generalisation	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Seizure cluster	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events1 affected473 at risk
Status epilepticus	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00013 events11 affected473 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected473 at risk
Temporal lobe epilepsy	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Visual field defect	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Pregnancy on contraceptive	Pregnancy, puerperium and perinatal conditions	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Epileptic psychosis	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0003 events3 affected473 at risk
Hallucination	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Mental disorder	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Suicidal ideation	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Suicide attempt	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Renal impairment	Renal and urinary disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected473 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Vocal cord leukoplakia	Respiratory, thoracic and mediastinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Abortion induced	Surgical and medical procedures	MedDRA16.1	Non-systematic Assessment	EG0003 events3 affected473 at risk
Wisdom teeth removal	Surgical and medical procedures	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected473 at risk
Varicose vein	Vascular disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk
Venous occlusion	Vascular disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected473 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vision blurred	Eye disorders	MedDRA16.1	Non-systematic Assessment	EG00029 events22 affected473 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG00057 events28 affected473 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG00064 events41 affected473 at risk
Nausea	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG00046 events30 affected473 at risk
Toothache	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG00047 events38 affected473 at risk
Vomiting	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG00066 events37 affected473 at risk
Pyrexia	General disorders	MedDRA16.1	Non-systematic Assessment	EG00053 events41 affected473 at risk
Gastroenteritis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG00036 events27 affected473 at risk
Nasopharyngitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG000510 events156 affected473 at risk
Pharyngitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG00038 events22 affected473 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG000208 events99 affected473 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG00037 events27 affected473 at risk
Dizziness	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG000318 events125 affected473 at risk
Headache	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG000177 events77 affected473 at risk
Somnolence	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00080 events41 affected473 at risk
Insomnia	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG00032 events26 affected473 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA16.1	Non-systematic Assessment	EG00043 events27 affected473 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA16.1	Non-systematic Assessment	EG00048 events27 affected473 at risk

Facility	Status	City	State	ZIP	Country	Contacts
86026		Beijing			China
86027

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