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 |
|---|---|---|---|---|---|---|---|---|
| CDC Poster | After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness. View CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness. | 0 | None | 0 | 495 | 0 | 495 | View |
| Patient-Centered Poster | After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness. View Patient-Centered Poster: The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating. | 0 | None | 0 | 495 | 0 | 495 | View |