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 |
|---|---|---|---|---|---|---|---|---|
| SITe Training for Accepting Providers | UW Health (accepting) providers will participate in a training to learn how to utilize SITe intervention tools during EGS transfer calls. Intervention to Support Interhospital Transfer Decisions (SITe): The SITe intervention and implementation toolkit was developed in Aim 1 through stakeholder activities. SITe, an intervention to support interhospital transfer decisions regarding older EGS patients, includes a checklist and script to be utilized by accepting providers during their conversations with referring providers. The investigators and stakeholders also developed a toolkit for implementation with resources to reduce barriers to and support facilitators of utilizing the tools. The toolkit includes: (1) the checklist and script; (2) methods to train accepting providers on the tools including a PowerPoint presentation and demonstration video; and (3) resources to familiarize other parties (transfer center nurses, referring providers, referring hospitals) with the SITe intervention. | 0 | None | 0 | 0 | 0 | 0 | View |