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 |
|---|---|---|---|---|---|---|---|---|
| COVID-19 Testing | The cohort participants will attend an in-person training on how to take an at-home COVID-19 test and also be provided with five at-home test kits at the training and every other month for a total of 35 kits over the course of a year. Public Health Intervention Package: The intervention package consists of two components: 1. At the time of study enrollment, participants will attend an in-person training on how to properly take an at-home COVID-19 test. Study staff will verbally walk through the steps of the test with the participant while the participant administers the test on themselves, with the opportunity to ask questions and receive corrective feedback, as needed. 2. To make COVID-19 testing more accessible, participants will be provided five at-home COVID-19 testing kits at the training and then every other month throughout the course of the year-long study for a total of 35 kits. | 1 | None | 0 | 102 | 0 | 102 | View |