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 |
|---|---|---|---|---|---|---|---|---|
| Physician-level Incentives | Examines the effect of physician-level financial incentives on hypertension quality of care Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes. | None | None | 0 | 19 | 0 | 19 | View |
| Practice-level Incentives | Examines the effect of practice-level financial incentives on hypertension quality of care Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes. | None | None | 0 | 20 | 0 | 20 | View |
| Physician- and Practice-level Incentives | Examines the effect of physician and practice-level financial incentives on hypertension quality of care Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives. | None | None | 0 | 19 | 0 | 19 | View |
| No Incentives (Control) | Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups. | None | None | 0 | 19 | 0 | 19 | View |