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 |
|---|---|---|---|---|---|---|---|---|
| Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts | Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode. Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy. | None | None | 0 | 20 | 0 | 20 | View |
| Coag Mode 30 Watts Power | Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care. Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy | None | None | 0 | 20 | 0 | 20 | View |