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 |
|---|---|---|---|---|---|---|---|---|
| MIND1 System IEM Detection (All Enrolled Participants) | On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device \[eg, smartphone\] app) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded IEM tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by MIND1 system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time it was detected by the MIND1 system compatible computing device (eg, smartphone). | 0 | None | 0 | 29 | 0 | 29 | View |