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 |
|---|---|---|---|---|---|---|---|---|
| Experimental - Collaboration Live Software | Non-diagnostic software solution: Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination. | 0 | None | 0 | 30 | 0 | 30 | View |