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 |
|---|---|---|---|---|---|---|---|---|
| SU Initiators | Initiators of Sulfonylurea between 01/01/2014 and 12/31/2021; sample size N=212,042. | 4867 | None | 0 | 0 | 0 | 0 | View |
| DPP4 Initiators | Initiators of DPP4 between 01/01/2014 and 12/31/2021; sample size N=5,862. | 235 | None | 0 | 0 | 0 | 0 | View |
| SGLT2i Initiators | Initiators of SGLT2i between 01/01/2014 and 12/31/2021; sample size N=14,858. | 117 | None | 0 | 0 | 0 | 0 | View |
| GLP-1RA Initiators | Initiators of GLP-1RA between 01/01/2014 and 12/31/2021; sample size N=9,219. | 109 | None | 0 | 0 | 0 | 0 | View |