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 |
|---|---|---|---|---|---|---|---|---|
| EP Procedure | Patient will continuously wear the CoVa TM 2 system until they are discharged for period of about 24 hours. During this period, data from the sensor will be sent to the Gateway and Cloud- based System, and then analyzed retrospectively. CoVa 2 Sensor: Upon completion of EP procedure, CoVa 2 sensor will be applied until discharge. Data from the sensor will be sent to the Gateway and Cloudbased system and analyzed retrospectively. | 0 | None | 0 | 20 | 0 | 20 | View |