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 |
|---|---|---|---|---|---|---|---|---|
| Standard | Local health department staff in the standard arm will receive Connect to Wellness intervention materials, multiple real-time training sessions delivered via webinar, access to a web-based platform that includes all intervention and training materials and has features allowing them to communicate with each other and with research staff, and a monthly group technical assistance call. Connect to Wellness: The research team will train LHD staff and offer them technical assistance to work with small worksites. LHD staff will be trained to deliver the Connect to Wellness program to worksites. Connect to Wellness is a program to disseminate EBIs to small worksites. Worksites receive guidance about EBIs and ongoing implementation assistance from a trained interventionist. In this study, LHD staff will be the interventionists. Worksites participating in Connect to Wellness complete three phases of activities, Assessment, Recommendations, and Implementation. LHD staff will receive Connect to Wellness intervention materials, multiple webinars delivered in real-time, access to a comprehensive intervention and training platform with features that allow them to connect with each other and with research staff, and group technical assistance calls to support their ability to recruit worksites in their communities and deliver Connect to Wellness to these worksites. | 0 | None | 0 | 0 | 0 | 0 | View |
| Enhanced | Local health department staff in the enhanced arm will receive all the Connect to Wellness intervention materials, training, and support as described for the standard arm. In addition, the participants in the enhanced arm can telephone research staff at will to receive additional technical assistance. Research staff will also contact participants monthly, if they do not request assistance proactively. Connect to Wellness: The research team will train LHD staff and offer them technical assistance to work with small worksites. LHD staff will be trained to deliver the Connect to Wellness program to worksites. Connect to Wellness is a program to disseminate EBIs to small worksites. Worksites receive guidance about EBIs and ongoing implementation assistance from a trained interventionist. In this study, LHD staff will be the interventionists. Worksites participating in Connect to Wellness complete three phases of activities, Assessment, Recommendations, and Implementation. LHD staff will receive Connect to Wellness intervention materials, multiple webinars delivered in real-time, access to a comprehensive intervention and training platform with features that allow them to connect with each other and with research staff, and group technical assistance calls to support their ability to recruit worksites in their communities and deliver Connect to Wellness to these worksites. | 0 | None | 0 | 0 | 0 | 0 | View |