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 |
|---|---|---|---|---|---|---|---|---|
| Tramadol | Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure | 0 | None | 0 | 38 | 0 | 38 | View |
| Placebo | 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure | 0 | None | 1 | 41 | 0 | 41 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| low conscious levels in post operative period | SYSTEMATIC_ASSESSMENT | Endocrine disorders | Placebo | View |