Post-Authorization Safety Study to Assess the Safety of V... | NCT00771927

Label	Type	Description	Intervention Names
Lacosamide		Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat	Drug: Lacosamide
Other AED		Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy

Name	Type	Description	Arm Group Labels	Other Names
Lacosamide	Drug	Vimpat was used as per site routine practices, and in-line with the marketing authorization.	Lacosamide

Measure	Description	Time Frame
The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study	Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake.	From Baseline up to 12 months

Measure	Description	Time Frame
The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study	Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake.

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

Label	URL
Product information	View source
FDA Safety Alerts and Recalls	View source

ID	Title	Description
FG000	Lacosamide	Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
FG001	Other AED	Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukopenia	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Atrial Flutter	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Palpitations	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Tachycardia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events1 affected493 at risk
Left Ventricular Failure	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Foetal Malformation	Congenital, familial and genetic disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Sudden Hearing Loss	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Diplopia	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Anorectal Disorder	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Cyst Rupture	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Drug Ineffective	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Gait Disturbance	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Idiosyncratic Drug Reaction	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Pyrexia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Sudden Unexplained Death in Epilepsy	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Death	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Fatigue	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Furuncle	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Bronchopneumonia	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Brain Contusion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Facial Bones Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Jaw Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Vascular Graft Complication	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Ligament Rupture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Meniscus Lesion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Post-Traumatic Neck Syndrome	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Electroencephalogram	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Weight Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Investigation	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0012 events2 affected493 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Malignant Glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Neoplasm Progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Anal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Convulsion	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00018 events16 affected511 at risk EG00121 events17 affected493 at risk
Epilepsy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 events7 affected511 at risk EG0013 events3 affected493 at risk
Dizziness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected511 at risk EG0011 events1 affected493 at risk
Grand Mal Convulsion	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG00112 events11 affected493 at risk
Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0014 events4 affected493 at risk
Status Epilepticus	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0011 events1 affected493 at risk
Seizure Cluster	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events2 affected511 at risk EG0011 events1 affected493 at risk
Ataxia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events1 affected511 at risk EG0010 events0 affected493 at risk
Balance Disorder	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Complex Partial Seizures	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Hemiparesis	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Neuralgia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Partial Seizures	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0018 events5 affected493 at risk
Sciatica	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Somnolence	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Temporal Lobe Epilepsy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Toxic Encephalopathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Cognitive Disorder	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Paraparesis	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Postictal Paralysis	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events1 affected493 at risk
Psychomotor Seizures	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Depression	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0011 events1 affected493 at risk
Emotional Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Suicide Attempt	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Anxiety Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Conversion Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events1 affected511 at risk EG0010 events0 affected493 at risk
Delirium	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Disturbance in Social Behaviour	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Generalised Anxiety Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Mental Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Somatoform Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Aggression	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Expressive Language Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Panic Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Personality Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Rash Generalised	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Abortion Induced	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Brain Operation	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Abscess Drainage	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0013 events3 affected493 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Angina Pectoris	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Bundle Branch Block Right	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Ventricular Exrasystoles	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Atrioventricular Block First Degree	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Bradycardia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0013 events3 affected493 at risk
Conduction Disorder	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Palpitations	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Supraventricular Extrasystoles	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0012 events2 affected493 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Bundle Branch Block Left	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Tachycardia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Arteriovenous Malformation	Congenital, familial and genetic disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG00049 events44 affected511 at risk EG00112 events11 affected493 at risk
Eustachian Tube Disorder	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Vestibular Disorder	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
External Ear Inflammation	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Diplopia	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG00061 events52 affected511 at risk EG00119 events18 affected493 at risk
Vision Blurred	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG00018 events18 affected511 at risk EG00113 events13 affected493 at risk
Visual Impairment	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0009 events9 affected511 at risk EG0012 events2 affected493 at risk
Accomodation Disorder	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Blepharospasm	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Conjunctival Hyperaemia	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Excessive Eye Blinking	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Eye Disorder	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Eye Haemorrhage	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Eye Pain	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Eye Swelling	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Ocular Discomfort	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Oscillopsia	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Saccadic Eye Movement	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Abnormal Sensation in Eye	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Dry Eye	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Exophthalmos	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Photopsia	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Retinal Infarction	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Visual Acuity Reduced	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00049 events47 affected511 at risk EG00124 events23 affected493 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00016 events15 affected511 at risk EG0019 events8 affected493 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0009 events9 affected511 at risk EG00115 events15 affected493 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0006 events6 affected511 at risk EG0018 events8 affected493 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected511 at risk EG0013 events3 affected493 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events4 affected511 at risk EG0017 events7 affected493 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0015 events5 affected493 at risk
Flatulence	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0014 events3 affected493 at risk
Toothache	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0011 events1 affected493 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Aphthous Stomatitis	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Gastric Disorder	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Hypoaesthesia Oral	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Salivary Hypersecretion	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Tongue Spasm	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Coeliac Disease	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Gastritis	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Gingival Hyperplasia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Retching	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Fatigue	General disorders	MedDRA 15.0	Non-systematic Assessment	EG00093 events81 affected511 at risk EG00165 events61 affected493 at risk
Irritability	General disorders	MedDRA 15.0	Non-systematic Assessment	EG00012 events11 affected511 at risk EG00114 events13 affected493 at risk
Gait Disturbance	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0009 events8 affected511 at risk EG0018 events8 affected493 at risk
Asthenia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events4 affected511 at risk EG0011 events1 affected493 at risk
Pyrexia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected511 at risk EG0011 events1 affected493 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Oedema Peripheral	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0014 events4 affected493 at risk
Adverse Drug Reaction	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Chills	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Implant Site Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Oedema	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Spinal Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Chest Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Drug Therapeutic Incompability	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Feeling Abnormal	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Feeling Cold	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Feeling Hot	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Malaise	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Temperature Intolerance	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Hepatic Pain	Hepatobiliary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Hypersensitivity	Immune system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0008 events7 affected511 at risk EG00113 events11 affected493 at risk
Influenza	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0010 events0 affected493 at risk
Sinusitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Abscess	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Cystitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0004 events1 affected511 at risk EG0010 events0 affected493 at risk
Device Related Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Dysentery	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
H1N1 Influenza	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Helicobacter Gastritis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Infected Bites	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Intraspinal Abscess	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0012 events2 affected493 at risk
Vaginal Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Bronchitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Rash Pustular	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Candidiasis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Pertussis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Pneumonia	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Tooth Abscess	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Tooth Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0013 events3 affected493 at risk
Viral Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0008 events8 affected511 at risk EG0011 events1 affected493 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0005 events4 affected511 at risk EG0014 events3 affected493 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0005 events4 affected511 at risk EG0012 events2 affected493 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0011 events1 affected493 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Burns Third Degree	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Cervical Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Face Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0002 events1 affected511 at risk EG0011 events1 affected493 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Limb Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Tooth Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Nail Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Open Wound	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Weight Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG00016 events16 affected511 at risk EG0019 events8 affected493 at risk
Weight Decreased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected511 at risk EG00112 events12 affected493 at risk
Electrocardiogram QT Prolonged	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0011 events1 affected493 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0011 events1 affected493 at risk
Electroencephalogram	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Blood Cholesterol Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Blood Glucose Abnormal	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Blood Pressure Decreased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Electrocardiogram Q Wave Abnormal	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Electrocardiogram ST Segment Elevation	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Electrocardiogram T Wave Inversion	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Gamma-Glutamyltransferase Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0012 events2 affected493 at risk
Neurological Examination	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Neurological Examination Abnormal	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Activated Partial Thromboplastin Time Prolonged	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Blood Calcium Decreased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Blood Creatine Phosphokinase Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Blood Pressure Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
C-Reactive Protein Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Electrocardiogram Low Voltage	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Investigation	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected511 at risk EG00111 events10 affected493 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Lactose Intolerance	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Vitamin B12 Deficiency	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Hyperhomocysteinaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events1 affected493 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0013 events3 affected493 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Increased Appetite	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Iron Deficiency	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 events7 affected511 at risk EG0018 events8 affected493 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected511 at risk EG0011 events1 affected493 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0010 events0 affected493 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0011 events1 affected493 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0011 events1 affected493 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0011 events1 affected493 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0014 events4 affected493 at risk
Posture Abnormal	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Sensation of Heaviness	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Tenosynovitis Stenosans	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Muscle Tightness	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Oligodendroglioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Benign Anorectal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Dizziness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG000129 events108 affected511 at risk EG00149 events45 affected493 at risk
Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00057 events53 affected511 at risk EG00130 events26 affected493 at risk
Convulsion	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00021 events21 affected511 at risk EG00118 events15 affected493 at risk
Tremor	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00024 events20 affected511 at risk EG00115 events12 affected493 at risk
Ataxia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00017 events16 affected511 at risk EG0018 events8 affected493 at risk
Memory Impairment	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00016 events16 affected511 at risk EG00114 events14 affected493 at risk
Somnolence	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00016 events14 affected511 at risk EG0017 events7 affected493 at risk
Aphasia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00011 events11 affected511 at risk EG00112 events12 affected493 at risk
Balance Disorder	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00011 events10 affected511 at risk EG0014 events4 affected493 at risk
Disturbance in Attention	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0008 events8 affected511 at risk EG0018 events8 affected493 at risk
Nystagmus	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0009 events6 affected511 at risk EG0010 events0 affected493 at risk
Paraesthesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0006 events6 affected511 at risk EG00112 events12 affected493 at risk
Cognitive Disorder	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected511 at risk EG0015 events5 affected493 at risk
Lethargy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected511 at risk EG0011 events1 affected493 at risk
Migraine	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected511 at risk EG0012 events2 affected493 at risk
Speech Disorder	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected511 at risk EG0014 events4 affected493 at risk
Amnesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0011 events1 affected493 at risk
Epilepsy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events3 affected511 at risk EG0012 events2 affected493 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events3 affected511 at risk EG0010 events0 affected493 at risk
Aura	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Coordination Abnormal	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Grand Mal Convulsion	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0014 events3 affected493 at risk
Partial Seizures	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events2 affected511 at risk EG0011 events1 affected493 at risk
Cerebellar Ataxia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Complex Partial Seizures	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0013 events2 affected493 at risk
Cubital Tunnel Syndrome	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Dizziness Postural	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Dysaesthesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Dysarthria	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0012 events2 affected493 at risk
Dysgeusia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Dysgraphia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Dyskinesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Formication	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Hypertonia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Hypotonia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Loss of Consciousness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Myoclonus	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Poor Quality Sleep	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Psychomotor Hyperactivity	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0012 events2 affected493 at risk
Sciatica	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Sedation	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Simple Partial Seizures	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Altered State of Consciousness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Depressed Level of Consciousness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Drug Withdrawal Convulsions	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Head Titubation	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Hypokinesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Intention Tremor	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Motor Dysfunction	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Myoclonic Epilepsy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Nerve Compression	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Paralysis	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Parosmia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Periodic Limb Movement Disorder	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Petit Mal Epilepsy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Postictal Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Psychomotor Skills Impaired	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Seizure Cluster	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Syncope	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Tension Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Vascular Parkinsonism	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Visual Field Defect	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Depression	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG00013 events13 affected511 at risk EG00123 events20 affected493 at risk
Insomnia	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG00014 events13 affected511 at risk EG00115 events15 affected493 at risk
Aggression	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0008 events8 affected511 at risk EG00120 events20 affected493 at risk
Anxiety	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0009 events8 affected511 at risk EG0016 events6 affected493 at risk
Sleep Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0006 events6 affected511 at risk EG00112 events11 affected493 at risk
Restlessness	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected511 at risk EG0014 events4 affected493 at risk
Depressed Mood	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected511 at risk EG0015 events5 affected493 at risk
Abnormal Behaviour	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0010 events0 affected493 at risk
Agitation	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0013 events3 affected493 at risk
Confusional State	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0016 events6 affected493 at risk
Mood Altered	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0013 events3 affected493 at risk
Affect Lability	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Bradyphrenia	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0011 events1 affected493 at risk
Mood Swings	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0019 events8 affected493 at risk
Nightmare	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0011 events1 affected493 at risk
Personality Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Abnormal Dreams	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events1 affected511 at risk EG0010 events0 affected493 at risk
Affective Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Apathy	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Drepressive Symptom	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Disorientation	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Dyssomnia	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Dysthymic Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Hallucination	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Impaired Reasoning	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Listless	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Loss of Libido	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Mental Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Nervousness	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Nocturnal Fear	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Reading Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Somatoform Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Stress	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Suicidal Ideation	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
TIC	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Anxiety Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Decreased Activity	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Emotional Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0014 events4 affected493 at risk
Food Aversion	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Initial Insomnia	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Libido Decreased	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Major Depression	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Mania	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Panic Attack	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Panic Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Paranoia	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Postictal Psychosis	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Polyuria	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Chromaturia	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Micturition Frequency Decreased	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Micturition Urgency	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events1 affected511 at risk EG0010 events0 affected493 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0011 events1 affected493 at risk
Menstrual Disorder	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Erectile Dysfunction	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0013 events3 affected493 at risk
Menopausal Disorder	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0014 events4 affected493 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0012 events2 affected493 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events1 affected511 at risk EG0010 events0 affected493 at risk
Throat Irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Painful Respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00012 events11 affected511 at risk EG0015 events5 affected493 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0008 events8 affected511 at risk EG00111 events10 affected493 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected511 at risk EG0012 events2 affected493 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0010 events0 affected493 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected511 at risk EG0011 events1 affected493 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0010 events0 affected493 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Swelling Face	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0016 events5 affected493 at risk
Heat Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Rash Generalized	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Skin Reaction	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Amygdalohippocampectomy	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Brain Operation	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Drug Therapy Changed	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Intervertebral Disc Operation	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Tooth Extraction	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Uterine Dilation and Curettage	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Knee Operation	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Vagal Nerve Stimulator Implantation	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0011 events1 affected493 at risk
Hypertension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected511 at risk EG0013 events3 affected493 at risk
Hot Flush	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected511 at risk EG0011 events1 affected493 at risk
Circulatory Collapse	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Haematoma	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0014 events4 affected493 at risk
Venous Thrombosis	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Peripheral Coldness	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0012 events2 affected493 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected511 at risk EG0010 events0 affected493 at risk
Folate Deficiency	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected511 at risk EG0013 events3 affected493 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Bron			France

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

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

ID	Title	Description
BG000	Lacosamide	Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
BG001	Other AED	Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
BG002	Total	Total of all reporting 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	Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat			78	511	359	511
EG001	Other AED	Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy			64	493	299	493