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 |
|---|---|---|---|---|---|---|---|---|
| Sugar Water | 500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3 Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3 | None | None | 0 | 8 | 2 | 8 | View |
| Ibuprofen | 800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3 ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3 | None | None | 0 | 6 | 1 | 6 | View |