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 |
|---|---|---|---|---|---|---|---|---|
| Topical Corticosteroid Alone | Topical corticosteroid is applied to the patient's lesion. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm. | 0 | None | 0 | 3 | 0 | 3 | View |
| 532nm Laser and Topical Corticosteroid | 532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 532nm laser: 532nm laser will be used to treat the lesion in this study arm. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm. | 0 | None | 0 | 1 | 0 | 1 | View |
| 1064nm Laser and Topical Corticosteroid | 1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. 1064nm laser: 1064nm laser will be used to treat the lesion in this study arm. Topical corticosteroid: The topical corticosteroid will be used to treat the lesion in this study arm. | 0 | None | 0 | 3 | 0 | 3 | View |