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 |
|---|---|---|---|---|---|---|---|---|
| Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. (PMID: 35568903) | 0 | None | 0 | 0 | 0 | 0 | View |
| AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. (PMID: 35568903) LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. (PMID: 32901440) | 0 | None | 0 | 0 | 0 | 0 | View |