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 |
|---|---|---|---|---|---|---|---|---|
| First Year psychology_structured | First year psychology students who watched the video where the physician gives structured information to the patient Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form | None | None | 0 | 63 | 0 | 63 | View |
| First Year psychology_non-structured | First year psychology students who watched the video where the physician gives non-structured information to the patient no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form | None | None | 0 | 42 | 0 | 42 | View |
| First Year medical_structured | First year medical students who watched the video where the physician gives structured information to the patient Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form | None | None | 0 | 60 | 0 | 60 | View |
| First Year mediclal_non-structured | First year medical students who watched the video where the physician gives non-structured information to the patient no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form | None | None | 0 | 38 | 0 | 38 | View |
| Third Year medical_structured | Third year medical students who watched the video where the physician gives structured information to the patient Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form | None | None | 0 | 20 | 0 | 20 | View |
| Third Year medical_non-structured | Third year medical students who watched the video where the physician gives non-structured information to the patient no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form | None | None | 0 | 19 | 0 | 19 | View |