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 |
|---|---|---|---|---|---|---|---|---|
| KeraStat Gel-treated Wound | Each enrolled subject will have 2 wounds. One wound will be randomized to the KeraStat Gel arm and the other will be assigned the Silver Sulfadiazine arm. The KeraStat Gel area of injury will be dressed with KeraStat Gel and covered by a secondary dressing. The SSD area of injury will be dressed with SSD and covered by a secondary dressing. Subjects will be instructed to change the dressings per instructions for use. | 0 | None | 0 | 14 | 0 | 14 | View |
| Silver Sulfadiazine-treated Wound | Each enrolled subject will have 2 wounds. One wound will be randomized to the KeraStat Gel arm and the other will be assigned the Silver Sulfadiazine arm. The KeraStat Gel area of injury will be dressed with KeraStat Gel and covered by a secondary dressing. The SSD area of injury will be dressed with SSD and covered by a secondary dressing. Subjects will be instructed to change the dressings per instructions for use. | 0 | None | 0 | 14 | 0 | 14 | View |