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 |
|---|---|---|---|---|---|---|---|---|
| Clindamycin and BPO Gel | Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe). | None | None | 0 | 27 | 2 | 27 | View |
| Dapsone Gel | Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe). | None | None | 0 | 25 | 2 | 25 | View |