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 |
|---|---|---|---|---|---|---|---|---|
| Group 1: Agressive Intervention | Hospitals were randomized to an aggressive intervention strategy or to "business as usual". The hospitals randomized to the aggressive intervention strategy underwent the following: 1. Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays. 2. Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers 3. Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing 4. Written plan from sites detailing plans to change processes of care. | None | None | 0 | 448 | 0 | 448 | View |
| Group 2: Control Strategy | Hospitals randomized to the control group were instructed to conduct "business as usual". Business as usual was defined as normal protocol for treatment of STEMI patients at each individual site +/- quality improvement efforts. No contact or advice was given to the sites from the coordinating center. | None | None | 0 | 434 | 0 | 434 | View |