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 |
|---|---|---|---|---|---|---|---|---|
| Propranolol Arm | Allocated to propranolol (n=5) Lost to follow-up (n=2) * Withdrew after baseline visit due to not feeling seeing a benefit (n=1) * Withdrew after 6-week visit -no reason given (n=1) Completed (n=4 at 6 weeks) (n=3 at 12 weeks) | 0 | None | 0 | 5 | 1 | 5 | View |
| Placebo Arm | Allocated to placebo (n=4) Lost to follow-up (n=2) * Withdrew after baseline visit - no reason given (n=1) * Withdrew after baseline visit due to worsening behaviors (n=1) Completed (n=2 at 6 weeks) (n=2 at 12 weeks) | 0 | None | 0 | 4 | 1 | 4 | View |