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 |
|---|---|---|---|---|---|---|---|---|
| Group 1 | placebo control without medication. Placebos: no medication, healthy subjects. | 0 | None | 0 | 5 | 0 | 5 | View |
| Group 2 | hyper-reactive responser after clopidogrel. clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit) | 0 | None | 0 | 5 | 0 | 5 | View |
| Group 3 | hypo-reactive responser after clopidogrel. clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit) | 0 | None | 0 | 5 | 0 | 5 | View |
| Group 4 | normo-reactive responser after clopidogrel. clopidogrel: routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit) | 0 | None | 0 | 5 | 0 | 5 | View |
| Group 5 | reaction after OPC-13013 | 0 | None | 0 | 5 | 0 | 5 | View |
| Group 6 | reaction after AR-C | 0 | None | 0 | 5 | 0 | 5 | View |
| Group 7 | reaction after simastatin | 0 | None | 0 | 5 | 0 | 5 | View |