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 |
|---|---|---|---|---|---|---|---|---|
| Control Group (CG) | Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited will constitute the usual care control group. | None | None | 0 | 746 | 0 | 746 | View |
| Intervention Group (IG1) | Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group. The intervention group will be made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it. | None | None | 0 | 159 | 0 | 159 | View |
| Intervention Group (IG2) | Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group. The intervention group will be made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate. | None | None | 0 | 1362 | 0 | 1362 | View |