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 |
|---|---|---|---|---|---|---|---|---|
| Age 5-9.9 HbSS/HbSβ0 | Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0 | None | None | 0 | 208 | 0 | 208 | View |
| Age 10-14.9 HbSS/HbSβ0 | Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0 | None | None | 0 | 240 | 0 | 240 | View |
| Age 15-24.9 HbSS/HbSβ0 | Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0 | None | None | 0 | 398 | 0 | 398 | View |
| Age >25 HbSS/HbSβ0 | Subjects \> 25 yrs w/SCD diagnosis HbSS/HbSβ0 | None | None | 0 | 362 | 0 | 362 | View |
| Age >15 HbSC/HbSβ+ | Subjects \> 15 yrs w/SCD diagnosis HbSC/HbSβ+ | None | None | 0 | 251 | 0 | 251 | View |