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 |
|---|---|---|---|---|---|---|---|---|
| Initial PROM Plus Monthly PROM | These patients received usual care plus monthly PROMs while on the waitlist. Patient-rated outcome measures: PROMs are scales that are validated in behavioral health for tracking symptoms of depression, anxiety, and other conditions. They can be self-administered or given by a clinician. All patients receive PROMs on entering our clinic. The difference in this intervention is those randomized to the active treatment will receive monthly PROMs until their appointment with the clinician. Usual care patients will only have PROMs at the intake and then at the appointment with their assigned clinician. | 0 | None | 0 | 70 | 0 | 70 | View |
| Usual Care | Patients completed the initial bundle of PROMs, then no further PROMs while they remained on the waitlist. | 0 | None | 0 | 78 | 0 | 78 | View |