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 |
|---|---|---|---|---|---|---|---|---|
| HEARTS Implementation - Patients | A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study. Integrated Diabetes and Hypertension Primary Care Model: The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. 1. Training health workers on diabetes and hypertension treatment protocols 2. Team-based care and task sharing 3. Strengthening access to medications and diagnostics 4. Electronic medical record system and registry 5. Systems monitoring and feedback of key indicators | 0 | None | 0 | 964 | 0 | 964 | View |
| HEARTS Implementation - Providers | A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants. Integrated Diabetes and Hypertension Primary Care Model - Providers: The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. 1. Training health workers on diabetes and hypertension treatment protocols 2. Team-based care and task sharing 3. Strengthening access to medications and diagnostics 4. Electronic medical record system and registry 5. Systems monitoring and feedback of key indicators Health care providers will administer this intervention to patient participants and will report on their experience. | 0 | None | 0 | 0 | 0 | 0 | View |