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 |
|---|---|---|---|---|---|---|---|---|
| Enhanced Recovery Pathway | An evidence-based enhanced recovery pathway for 1- and 2-level open lumbar fusion based on Enhanced Recovery After Surgery™ Society principles of care. The study team emphasizes that all components of the ERAS pathway are considered standard of care at this institution. | 0 | None | 0 | 25 | 0 | 25 | View |
| Usual Care | Anesthesiologist/surgeon in charge of patients randomized to the usual care arm had sole discretion over intraoperative treatment and there were no specific study interventions. | 0 | None | 0 | 26 | 0 | 26 | View |