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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phenytoin | Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period. x x | None | None | 4 | 24 | 0 | 24 | View |
| Valproate | Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation. valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses. | None | None | 1 | 5 | 1 | 5 | View |
| Levetiracetam | Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses. levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses. | None | None | 4 | 16 | 0 | 16 | View |
| No Anticonvulsant | Participants randomized to Group 4 will receive no drug intervention. | None | None | 3 | 7 | 0 | 7 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| vasospasm | None | Nervous system disorders | None | View |
| deep venous thrombosis | None | Vascular disorders | None | View |
| hydrocephalus | None | Nervous system disorders | None | View |
| pulmonary edema | None | Respiratory, thoracic and mediastinal disorders | None | View |
| drug fever | None | Immune system disorders | None | View |
| cerebral infarction | None | Nervous system disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| urinary tract infection | None | Infections and infestations | None | View |