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:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
NCT ID:
NCT02201251
Description:
The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Frequency Threshold:
2
Time Frame:
Up to Day 390
Study:
NCT02201251
Study Brief:
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Topiramate | Participants received topiramate weight-based sprinkle capsule and tablet, as tolerated (not to exceed 350 milligrams per day \[mg/day\] for participants 2 to less than \[\<\] 10 years of age, and not to exceed 400 mg/day for participants 10 to 15 years of age), twice daily (BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available topiramate or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. | 0 | None | 0 | 28 | 25 | 28 | View |
| Levetiracetam | Participants received levetiracetam weight-based tablet or oral solution, as tolerated (not to exceed 60 milligrams per kilogram per day \[mg/kg/day\] for participants 2 to 15 years of age). The daily dosage was increased every 2 weeks by increments of 20 mg/kg/day to the recommended daily dosage of 60 mg/kg/day. The maximum recommended daily dosage was 3000 mg (1500 mg BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available levetiracetam or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days. | 0 | None | 5 | 35 | 29 | 35 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Skull Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Myositis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Generalised Tonic-Clonic Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eosinophilia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 22.1 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 22.1 | View |
| Ear Pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 22.1 | View |
| Middle Ear Effusion | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 22.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 22.1 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Epigastric Discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Paraesthesia Oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Influenza Like Illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Sluggishness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Ear Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Gastroenteritis Enteroviral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Gastrointestinal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Pneumococcal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Pulpitis Dental | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Respiratory Tract Infection Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Scarlet Fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Staphylococcal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Staphylococcal Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Systemic Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Varicella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Head Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Lip Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Thermal Burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Tooth Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Ammonia Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Blood Potassium Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Blood Triglycerides Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Platelet Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Vitamin D Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.1 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Metabolic Acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | View |
| Skin Papilloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | View |
| Ataxia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Cognitive Disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Disturbance in Attention | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Dizziness Exertional | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Memory Impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Mental Impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Partial Seizures | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Psychomotor Hyperactivity | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Affective Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Agitation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Attention Deficit/Hyperactivity Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Emotional Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Hyposomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Learning Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Mood Swings | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Nervousness | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Sleep Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.1 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 22.1 | View |
| Menorrhagia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 22.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Throat Tightness | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |
| Blister | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Dermatitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Keratosis Pilaris | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Rash Papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Rash Pruritic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 22.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Laryngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.1 | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.1 | View |
| Balance Disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.1 | View |
| Rhinitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | View |