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 |
|---|---|---|---|---|---|---|---|---|
| Culturally-targeted Fear Appeal Message HPV Self-sampling Kit | Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit. | 0 | None | 0 | 74 | 0 | 74 | View |
| HPV Self-sampling Kit + Interview | Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool. HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative). | 0 | None | 0 | 10 | 0 | 10 | View |
| HPV Self-sampling Kit | Participants will receive an HPV self-sampling kit to screen for HPV HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling. | 0 | None | 0 | 89 | 0 | 89 | View |