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 |
|---|---|---|---|---|---|---|---|---|
| Diabetes | During year 1 of the proposed project, the investigative team will identify a valid cohort of patients with type 2 diabetes using EHR data. The cohort of patients under study will be defined as all patients age 18 and older with an indication of type 2 diabetes during the proposed study time frame (2009-2019). Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes. Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes | 0 | None | 0 | 0 | 0 | 0 | View |
| Pre-Diabetes | The cohort of patients under study will be defined as patients age 18 and older who are at risk for the development of diabetes, based on being overweight. Patients seen at one of the six PaTH institutions will be included in the at-risk cohort if they have a BMI ≥ 25 kg/m2, based on most recent recorded weight and at least one recorded height. Weight Counseling: This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes. | 0 | None | 0 | 0 | 0 | 0 | View |
| COVID-19 | This cohort of patients will be defined as patients age 18 and older who have received a diagnosis of COVID-19. Telemedicine: This is a natural experiment which will observe the impact of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes | 0 | None | 0 | 0 | 0 | 0 | View |