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 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
NCT ID:
NCT01229735
Description:
The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
Frequency Threshold:
5
Time Frame:
Adverse Events (AEs) were collected from Visit 1 (Week -4) until final Visit 12 (Week 53).
Study:
NCT01229735
Study Brief:
Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Levetiracetam | 250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks | None | None | 10 | 177 | 86 | 177 | View |
| Topiramate | 25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks | None | None | 15 | 166 | 91 | 166 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA18.0 | View |
| Arteriovenous malformation | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA18.0 | View |
| Atrial septal defect | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA18.0 | View |
| Photophobia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA18.0 | View |
| Alcoholic pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.0 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.0 | View |
| Duodenal ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.0 | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA18.0 | View |
| Chronic tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.0 | View |
| Face injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.0 | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.0 | View |
| Joint dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.0 | View |
| Radius fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.0 | View |
| Spinal compression fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA18.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.0 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.0 | View |
| Trigger finger | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA18.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |
| Dyskinesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |
| Loss of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |
| Stupor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA18.0 | View |
| Calculus ureteric | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA18.0 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA18.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA18.0 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA18.0 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA18.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA18.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA18.0 | View |