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 |
|---|---|---|---|---|---|---|---|---|
| PillCam SB3EX | Patients who were eligible to participate in the study were recruited and enrolled. Enrolled participants were given instructions for capsule endoscopy as per standard of practice at our institution. External sensors and data recorder for use with the PillCam capsule were placed. Patients swallowed the capsule. All capsule endoscopy were allowed to run/record until the recording terminates due to battery outage (usually after 12 h) or passage of CE out of the gastrointestinal tract, as indicated by cessation of flashing light on the recorder. External sensors and data recorder were removed at the end of the recording and patients returned the equipment to the institution the next day. | None | None | 0 | 57 | 0 | 57 | View |