Time Frame |
From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
|
Adverse Event Reporting Description |
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
|
|
Arm/Group Title
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Perampanel
|
Arm/Group Description |
Participants previously receiving p...
|
Arm/Group Description |
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
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|
|
Perampanel
|
|
Affected / at Risk (%) |
Total |
--/-- |
|
|
Perampanel
|
|
Affected / at Risk (%) |
Total |
288/1216 (23.68%) |
Blood and lymphatic system disorders |
|
Anaemia |
1/1216 (0.08%) |
Cardiac disorders |
|
Angina pectoris |
3/1216 (0.25%) |
Atrial fibrillation |
3/1216 (0.25%) |
Bradycardia |
2/1216 (0.16%) |
Acute coronary syndrome |
1/1216 (0.08%) |
Angina unstable |
1/1216 (0.08%) |
Atrial flutter |
1/1216 (0.08%) |
Atrioventricular dissociation |
1/1216 (0.08%) |
Cardiac failure |
1/1216 (0.08%) |
Cardiovascular insufficiency |
1/1216 (0.08%) |
Coronary artery stenosis |
1/1216 (0.08%) |
Mitral valve incompetence |
1/1216 (0.08%) |
Myocardial infarction |
1/1216 (0.08%) |
Sick sinas syndrome |
1/1216 (0.08%) |
Congenital, familial and genetic disorders |
|
Hypertrophic cardiomyopathy |
1/1216 (0.08%) |
Skull malformation |
1/1216 (0.08%) |
Ear and labyrinth disorders |
|
Vertigo |
1/1216 (0.08%) |
Conductive deafness |
1/1216 (0.08%) |
Endocrine disorders |
|
Goitre |
1/1216 (0.08%) |
Eye disorders |
|
Conjunctivitis allergic |
1/1216 (0.08%) |
Iritis |
1/1216 (0.08%) |
Visual impairment |
1/1216 (0.08%) |
Gastrointestinal disorders |
|
Gastritis |
3/1216 (0.25%) |
Nausea |
3/1216 (0.25%) |
Colitis |
1/1216 (0.08%) |
Colitis ischaemic |
1/1216 (0.08%) |
Colitis microscopic |
1/1216 (0.08%) |
Duodenal ulcer |
1/1216 (0.08%) |
Duodenitis |
1/1216 (0.08%) |
Enterocolitis |
1/1216 (0.08%) |
Gastroesophageal reflux disease |
1/1216 (0.08%) |
Ileus |
1/1216 (0.08%) |
Inguinal hernia |
1/1216 (0.08%) |
Pancreatitis acute |
1/1216 (0.08%) |
Small intestine obstruction |
1/1216 (0.08%) |
Vomiting |
1/1216 (0.08%) |
General disorders |
|
Gait disturbance |
2/1216 (0.16%) |
Pain |
2/1216 (0.16%) |
Cyst |
1/1216 (0.08%) |
Death |
1/1216 (0.08%) |
Drug ineffective |
1/1216 (0.08%) |
Fatigue |
1/1216 (0.08%) |
General physical health deterioration |
1/1216 (0.08%) |
Hyperthermia |
1/1216 (0.08%) |
Non-cardiac chest pain |
1/1216 (0.08%) |
Pyrexia |
1/1216 (0.08%) |
Sudden death |
1/1216 (0.08%) |
Hepatobiliary disorders |
|
Cholelithiasis |
4/1216 (0.33%) |
Cholecystitis |
2/1216 (0.16%) |
Infections and infestations |
|
Pneumonia |
13/1216 (1.07%) |
Urinary tract infection |
6/1216 (0.49%) |
Appendicitis |
5/1216 (0.41%) |
Device related infection |
2/1216 (0.16%) |
Postoperative wound infection |
2/1216 (0.16%) |
Tooth abscess |
2/1216 (0.16%) |
Wound infection staphylococcal |
2/1216 (0.16%) |
Abscess limb |
1/1216 (0.08%) |
Appendicitis perforated |
1/1216 (0.08%) |
Bacterial disease carrier |
1/1216 (0.08%) |
Bronchitis |
1/1216 (0.08%) |
Cellulitis |
1/1216 (0.08%) |
Influenza |
1/1216 (0.08%) |
Klebsiella infection |
1/1216 (0.08%) |
Meningitis |
1/1216 (0.08%) |
Oral infection |
1/1216 (0.08%) |
Pharyngitis |
1/1216 (0.08%) |
Post procedural pneumonia |
1/1216 (0.08%) |
Pyelonephritis |
1/1216 (0.08%) |
Renal cyst infection |
1/1216 (0.08%) |
Respiratory tract infection |
1/1216 (0.08%) |
Sepsis |
1/1216 (0.08%) |
Septic shock |
1/1216 (0.08%) |
Tuberculosis |
1/1216 (0.08%) |
Typhoid fever |
1/1216 (0.08%) |
Wound infection |
1/1216 (0.08%) |
Injury, poisoning and procedural complications |
|
Head injury |
12/1216 (0.99%) |
Ankle fracture |
7/1216 (0.58%) |
Fall |
5/1216 (0.41%) |
Road traffic accident |
5/1216 (0.41%) |
Toxicity to various agents |
5/1216 (0.41%) |
Contusion |
4/1216 (0.33%) |
Facial bones fracture |
4/1216 (0.33%) |
Craniocerebral injury |
3/1216 (0.25%) |
Foot fracture |
3/1216 (0.25%) |
Lumbar vertebral fracture |
3/1216 (0.25%) |
Accidental overdose |
2/1216 (0.16%) |
Brain contusion |
2/1216 (0.16%) |
Clavicle fracture |
2/1216 (0.16%) |
Extradural haematoma |
2/1216 (0.16%) |
Fibula fracture |
2/1216 (0.16%) |
Hand fracture |
2/1216 (0.16%) |
Humerus fracture |
2/1216 (0.16%) |
Jaw fracture |
2/1216 (0.16%) |
Laceration |
2/1216 (0.16%) |
Lower limb fracture |
2/1216 (0.16%) |
Rib fracture |
2/1216 (0.16%) |
Subdural haematoma |
2/1216 (0.16%) |
Tibia fracture |
2/1216 (0.16%) |
Traumatic intracranial haemorrhage |
2/1216 (0.16%) |
Abdominal injury |
1/1216 (0.08%) |
Animal bite |
1/1216 (0.08%) |
Burns second degree |
1/1216 (0.08%) |
Burns third degree |
1/1216 (0.08%) |
Cartilage injury |
1/1216 (0.08%) |
Cervical vertebral fracture |
1/1216 (0.08%) |
Concussion |
1/1216 (0.08%) |
Epidural haemorrhage |
1/1216 (0.08%) |
Excoriation |
1/1216 (0.08%) |
Forearm fracture |
1/1216 (0.08%) |
Gastrointestinal stoma complication |
1/1216 (0.08%) |
Hip fracture |
1/1216 (0.08%) |
Intentional overdose |
1/1216 (0.08%) |
Joint dislocation |
1/1216 (0.08%) |
Limb injury |
1/1216 (0.08%) |
Limb traumatic amputation |
1/1216 (0.08%) |
Muscle strain |
1/1216 (0.08%) |
Neck injury |
1/1216 (0.08%) |
Post concussion syndrome |
1/1216 (0.08%) |
Post procedural haemorrhage |
1/1216 (0.08%) |
Procedural intestinal perforation |
1/1216 (0.08%) |
Radius fracture |
1/1216 (0.08%) |
Skin laceration |
1/1216 (0.08%) |
Skull fracture |
1/1216 (0.08%) |
Skull fractured base |
1/1216 (0.08%) |
Subcutaneous haematoma |
1/1216 (0.08%) |
Subdural haemorrhage |
1/1216 (0.08%) |
Traumatic iritis |
1/1216 (0.08%) |
Wound |
1/1216 (0.08%) |
Investigations |
|
Clostridium test positive |
1/1216 (0.08%) |
Heart rate irregular |
1/1216 (0.08%) |
Weight decreased |
1/1216 (0.08%) |
Metabolism and nutrition disorders |
|
Hyponatraemia |
3/1216 (0.25%) |
Dehydration |
1/1216 (0.08%) |
Diabetic ketoacidosis |
1/1216 (0.08%) |
Hypernatraemia |
1/1216 (0.08%) |
Hypochloraemia |
1/1216 (0.08%) |
Hypovolaemia |
1/1216 (0.08%) |
Musculoskeletal and connective tissue disorders |
|
osteoarthritis |
5/1216 (0.41%) |
Back pain |
2/1216 (0.16%) |
Muscular weakness |
2/1216 (0.16%) |
Bursitis |
1/1216 (0.08%) |
Musculoskeletal chest pain |
1/1216 (0.08%) |
Periarthritis |
1/1216 (0.08%) |
Pseudarthrosis |
1/1216 (0.08%) |
Scoliosis |
1/1216 (0.08%) |
Soft tissue necrosis |
1/1216 (0.08%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
Colon cancer |
2/1216 (0.16%) |
Benign lung neoplasm |
1/1216 (0.08%) |
Breast cancer |
1/1216 (0.08%) |
Breast cancer metastatic |
1/1216 (0.08%) |
Endometrial adenocarcinoma |
1/1216 (0.08%) |
Glioma |
1/1216 (0.08%) |
Papillary thyroid cancer |
1/1216 (0.08%) |
Tumour pain |
1/1216 (0.08%) |
Uterine leiomyoma |
1/1216 (0.08%) |
Nervous system disorders |
|
Convulsion |
43/1216 (3.54%) |
Status epilepticus |
16/1216 (1.32%) |
Epilepsy |
15/1216 (1.23%) |
Dizziness |
6/1216 (0.49%) |
Grand mal convulsion |
6/1216 (0.49%) |
Seizure cluster |
6/1216 (0.49%) |
Ataxia |
3/1216 (0.25%) |
Partial seizures |
3/1216 (0.25%) |
Partial seizures with secondary generalisation |
3/1216 (0.25%) |
Cerebral haemorrhage |
2/1216 (0.16%) |
Cerebrovascular accident |
2/1216 (0.16%) |
Drug withdrawal convulsions |
2/1216 (0.16%) |
Dysarthria |
2/1216 (0.16%) |
Hemiparesis |
2/1216 (0.16%) |
Hypoasthesia |
2/1216 (0.16%) |
Somnolence |
2/1216 (0.16%) |
Syncope |
2/1216 (0.16%) |
Carotid artery dissection |
1/1216 (0.08%) |
Carpal tunnel syndrome |
1/1216 (0.08%) |
Central nervous system lesion |
1/1216 (0.08%) |
Cerebral infarction |
1/1216 (0.08%) |
Cognitive disorder |
1/1216 (0.08%) |
Coma |
1/1216 (0.08%) |
Complex partial seizures |
1/1216 (0.08%) |
Dementia Alzheimer's type |
1/1216 (0.08%) |
Haemorrhage intracranial |
1/1216 (0.08%) |
Headache |
1/1216 (0.08%) |
Incoherent |
1/1216 (0.08%) |
Memory impairment |
1/1216 (0.08%) |
Multifocal motor nueropathy |
1/1216 (0.08%) |
Peripheral sensorimotor neuropathy |
1/1216 (0.08%) |
Postictal paralysis |
1/1216 (0.08%) |
Psychomotor hyperactivity |
1/1216 (0.08%) |
Simple partial seizures |
1/1216 (0.08%) |
Speech disorder |
1/1216 (0.08%) |
Spinal cord compression |
1/1216 (0.08%) |
Subarachnoid haemorrhage |
1/1216 (0.08%) |
Temporal lobe epilepsy |
1/1216 (0.08%) |
Transient ischaemic attack |
1/1216 (0.08%) |
Tremor |
1/1216 (0.08%) |
Vertebral artery dissection |
1/1216 (0.08%) |
Stupor |
1/1216 (0.08%) |
Pregnancy, puerperium and perinatal conditions |
|
Abortion spontaneous |
2/1216 (0.16%) |
Abortion spontaneous incomplete |
1/1216 (0.08%) |
Psychiatric disorders |
|
Aggression |
14/1216 (1.15%) |
Psychotic disorder |
8/1216 (0.66%) |
Suicidal ideation |
6/1216 (0.49%) |
Affective disorder |
5/1216 (0.41%) |
Depression |
5/1216 (0.41%) |
Acute psychosis |
4/1216 (0.33%) |
Suicide attempt |
4/1216 (0.33%) |
Disorientation |
3/1216 (0.25%) |
Paranoia |
3/1216 (0.25%) |
Abnormal behaviour |
2/1216 (0.16%) |
Agitation |
2/1216 (0.16%) |
Adjustment disorder |
1/1216 (0.08%) |
Anger |
1/1216 (0.08%) |
Catanoia |
1/1216 (0.08%) |
Confusional state |
1/1216 (0.08%) |
Delirium |
1/1216 (0.08%) |
Delusion |
1/1216 (0.08%) |
Delusion of grandeur |
1/1216 (0.08%) |
Epileptic psychosis |
1/1216 (0.08%) |
Hallucination,auditory |
1/1216 (0.08%) |
Homicidal ideation |
1/1216 (0.08%) |
Insomnia |
1/1216 (0.08%) |
Irritability |
1/1216 (0.08%) |
Major depression |
1/1216 (0.08%) |
Mental disorder due to a general medical condition |
1/1216 (0.08%) |
Mental status changes |
1/1216 (0.08%) |
Mood altered |
1/1216 (0.08%) |
Negativism |
1/1216 (0.08%) |
Obsessive thoughts |
1/1216 (0.08%) |
Personlaity change due to a general medical condition |
1/1216 (0.08%) |
Postictal psychosis |
1/1216 (0.08%) |
Renal and urinary disorders |
|
Nephrolithiasis |
2/1216 (0.16%) |
Urinary retention |
1/1216 (0.08%) |
Reproductive system and breast disorders |
|
Dysfuntional uterine bleeding |
2/1216 (0.16%) |
Bartholinitis |
1/1216 (0.08%) |
Breast enlargement |
1/1216 (0.08%) |
Haemorrhagic ovarian cyst |
1/1216 (0.08%) |
Menstrual disorder |
1/1216 (0.08%) |
Ovarian cyst |
1/1216 (0.08%) |
Ovarian mass |
1/1216 (0.08%) |
Ovarian rupture |
1/1216 (0.08%) |
Polycystic ovaries |
1/1216 (0.08%) |
Uterine cyst |
1/1216 (0.08%) |
Uterine haemorrhage |
1/1216 (0.08%) |
Uterine polyp |
1/1216 (0.08%) |
Respiratory, thoracic and mediastinal disorders |
|
Dyspnoea |
3/1216 (0.25%) |
Pneumonia aspiration |
2/1216 (0.16%) |
Acute respiratory failure |
1/1216 (0.08%) |
Chronic obstructive pulmonary disease |
1/1216 (0.08%) |
Nasal septum deviation |
1/1216 (0.08%) |
Pulmonary embolism |
1/1216 (0.08%) |
Respiratory failure |
1/1216 (0.08%) |
Skin and subcutaneous tissue disorders |
|
Dermatitis atopic |
1/1216 (0.08%) |
Rash maculo-papular |
1/1216 (0.08%) |
Surgical and medical procedures |
|
Abortion induced |
6/1216 (0.49%) |
Medical device removal |
1/1216 (0.08%) |
Vascular disorders |
|
Hypertension |
2/1216 (0.16%) |
Aortic aneurysm |
1/1216 (0.08%) |
Deep vein thrombosis |
1/1216 (0.08%) |
Hypotension |
1/1216 (0.08%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 13.1
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Perampanel
|
|
Affected / at Risk (%) |
Total |
1018/1216 (83.72%) |
Ear and labyrinth disorders |
|
Vertigo |
78/1216 (6.41%) |
Eye disorders |
|
Diplopia |
64/1216 (5.26%) |
Gastrointestinal disorders |
|
Diarrhoea |
84/1216 (6.91%) |
Nausea |
115/1216 (9.46%) |
Vomiting |
95/1216 (7.81%) |
General disorders |
|
Fatigue |
182/1216 (14.97%) |
Irritability |
69/1216 (5.67%) |
Gait disturbacne |
80/1216 (6.58%) |
Pyrexia |
79/1216 (6.50%) |
Infections and infestations |
|
Influenza |
70/1216 (5.76%) |
Nasopharyngitis |
142/1216 (11.68%) |
Upper respiratory tract infection |
107/1216 (8.80%) |
Injury, poisoning and procedural complications |
|
Fall |
116/1216 (9.54%) |
Laceration |
67/1216 (5.51%) |
Investigations |
|
Weight increased |
161/1216 (13.24%) |
Musculoskeletal and connective tissue disorders |
|
Back pain |
86/1216 (7.07%) |
Nervous system disorders |
|
Ataxia |
84/1216 (6.91%) |
Balance disorder |
74/1216 (6.09%) |
Convulsion |
78/1216 (6.41%) |
Dizziness |
591/1216 (48.60%) |
Dysarthria |
61/1216 (5.02%) |
Headache |
246/1216 (20.23%) |
Somnolence |
266/1216 (21.88%) |
Psychiatric disorders |
|
Anxiety |
79/1216 (6.50%) |
Depression |
82/1216 (6.74%) |
Insomnia |
86/1216 (7.07%) |
Irritability |
125/1216 (10.28%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 13.1
|