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 |
|---|---|---|---|---|---|---|---|---|
| Infographics | Infographic presentation of health information Infographic presentation of health information: The students in this group will read Cochrane systematic review summary in infographics format. Infographics format is a form of visual presentation of results of systematic review, supported by pictures and graphs. | 0 | None | 0 | 0 | 0 | 0 | View |
| Plain Language Summary | PLS presentation of health information PLS presentation of health information: The students randomized in PLS group will read text format with simple explanation of the survey topic main findings which is intended for lay audience. | 0 | None | 0 | 0 | 0 | 0 | View |
| Scientific Abstract | Scientific abstract presentation of health information Scientific abstract presentation of health information: The students in scientific abstract group will read the the text written for the academic population and practitioners. | 0 | None | 0 | 0 | 0 | 0 | View |