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 |
|---|---|---|---|---|---|---|---|---|
| ASCENT Intervention | ASCENT is a multi-component educational intervention delivered to dialysis facilities. End Stage Renal Disease (ESRD) facilities received performance feedback reports containing facility specific data, an educational webinar for dialysis facility medical directors and staff, an educational video for patients and staff; and the United Network for Organ Sharing (UNOS) pamphlet for dialysis facility staff detailing the changes in the new kidney allocation policy. The study intervention period occurred January 2017 through March 2017. | 0 | None | 0 | 0 | 0 | 0 | View |
| Standard Care Plus Educational Pamphlet | Dialysis facilities randomized to the control study arm delivered standard or usual care and education regarding transplantation. Dialysis facility staff were provided the United Network for Organ Sharing (UNOS) educational pamphlet detailing the changes in the new kidney allocation policy. The study intervention period occurred January 2017 through March 2017. | 0 | None | 0 | 0 | 0 | 0 | View |