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 |
|---|---|---|---|---|---|---|---|---|
| ncMCE Group | The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic. | 0 | None | 0 | 20 | 0 | 20 | View |
| MCE Group | The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides. | 0 | None | 0 | 20 | 0 | 20 | View |