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 |
|---|---|---|---|---|---|---|---|---|
| Fixed Site SOC Testing | Fixed site Standard of Care (SOC) testing Fixed site standard of care testing: This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule. | 0 | None | 0 | 277 | 0 | 277 | View |
| Community-based Testing | Community-based, mobile van testing Community-based, mobile van testing: This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them. | 0 | None | 0 | 273 | 0 | 273 | View |
| Self-collected Testing | Self-collected, home-based testing Self-collected, home-based testing: Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available. | 0 | None | 0 | 281 | 0 | 281 | View |