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 |
|---|---|---|---|---|---|---|---|---|
| WeTest-WeLink intervention | Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST. WeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST. | 0 | None | 0 | 900 | 0 | 900 | View |
| Control | Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST. Control condition: Contact information of local NGO for emergency referrals; free additional HST. | 0 | None | 0 | 900 | 0 | 900 | View |