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 |
|---|---|---|---|---|---|---|---|---|
| Pre-Implementation | Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching. | 0 | None | 0 | 0 | 0 | 0 | View |
| Post-implementation With Decision Coaching | Patients received the consent form, the SDM tool for stent selection, and decision coaching | 0 | None | 0 | 0 | 0 | 0 | View |
| Post-implementation Without Decision Coaching | Patients received the consent form and the SDM tool, but no decision coaching | 0 | None | 0 | 0 | 0 | 0 | View |