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 |
|---|---|---|---|---|---|---|---|---|
| Conventional Group | Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the conventional group will receive no intervention. Thirty and 40 min after dimethicone administration, subjects will additionally take 200 ml and 800 ml water, respectively, and undergo MCCG examination. | 0 | None | 0 | 40 | 0 | 40 | View |
| Position Change Group | Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. Thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively before undergoing MCCG examination. | 0 | None | 0 | 43 | 0 | 43 | View |