Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT01527006
Description:
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
Frequency Threshold:
5
Time Frame:
For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Study:
NCT01527006
Study Brief:
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study | During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. | None | None | 3 | 22 | 22 | 22 | View |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study | During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. | None | None | 5 | 28 | 25 | 28 | View |
| Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase | During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg. | None | None | 6 | 19 | 19 | 19 | View |
| Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase | During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg. | None | None | 7 | 22 | 22 | 22 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Developmental Hip Dysplasia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA Version 16.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Mastoiditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Otitis Externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Otitis Media Acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Respiratory Syncytial Virus Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Septic Shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 16.1 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Abnormal Behaviour | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Mental Status Changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 16.1 | View |
| Cyanosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 16.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 16.1 | View |
| Cyclic Vomiting Syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 16.1 | View |
| Otitis Media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Anticonvulsant Drug Level Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 16.1 | View |
| Foot Deformity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 16.1 | View |
| Muscle Contracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 16.1 | View |
| Status Epilepticus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Balance Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Psychomotor Hyperactivity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Aggression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Oppositional Defiant Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Tearfulness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | View |
| Nasal Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | View |
| Dermatitis Contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 16.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 16.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 16.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 16.1 | View |
| Phimosis | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA Version 16.1 | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 16.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 16.1 | View |
| Eye Irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 16.1 | View |
| Ocular Hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 16.1 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 16.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 16.1 | View |
| Aphthous Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 16.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 16.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 16.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 16.1 | View |
| Gingival Recession | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 16.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 16.1 | View |
| Oral Mucosal Discolouration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 16.1 | View |
| Autoimmune Disorder | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 16.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 16.1 | View |
| Atypical Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Clostridium Difficile Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Fungal Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Gastroenteritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Lice Infestation | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Tinea Capitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Viral Rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 16.1 | View |
| Epiphyseal Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 16.1 | View |
| Head Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 16.1 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 16.1 | View |
| Ligament Sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 16.1 | View |
| Blood Bicarbonate Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Blood Sodium Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Blood Triglycerides Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Blood Uric Acid Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Cardiac Murmur | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Cardiac Murmur Functional | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Globulins Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Heart Rate Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Tri-Iodothyronine Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 16.1 | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 16.1 | View |
| Metabolic Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 16.1 | View |
| Vitamin D Deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 16.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 16.1 | View |
| Pain In Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 16.1 | View |
| Posture Abnormal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 16.1 | View |
| Cognitive Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Drooling | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Dyskinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Hypotonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Intention Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Sedation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Speech Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |
| Abnormal Behaviour | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Depressed Mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Disorientation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Echolalia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Emotional Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Mood Altered | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Mood Swings | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Sleep Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Suicidal Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 16.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 16.1 | View |
| Enuresis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 16.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 16.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 16.1 | View |
| Vulval Disorder | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 16.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | View |
| Grunting | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | View |
| Rhinitis Allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | View |
| Skin Disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 16.1 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 16.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 16.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 16.1 | View |
| Gait Disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 16.1 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 16.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 16.1 | View |
| Ear Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Otitis Media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 16.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 16.1 | View |
| Thyroxine Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Weight Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 16.1 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 16.1 | View |
| Increased Aappetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 16.1 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 16.1 | View |