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 |
|---|---|---|---|---|---|---|---|---|
| Mobile Health Care Application | Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes. mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes. | None | None | 0 | 0 | 0 | 0 | View |
| Community Health Worker (CHW) | CHWs assist study patients in managing there health care in various ways. Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways. | None | None | 0 | 0 | 0 | 0 | View |
| CHWs and Mobile Health Care Application | Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application. | None | None | 0 | 0 | 0 | 0 | View |