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 |
|---|---|---|---|---|---|---|---|---|
| SCOUTS3 Optimization Arm | In a single-arm study, participants with ischemic stroke or intraparenchymal hemorrhage within 30 days will be tested for obstructive sleep apnea with a portable test during inpatient rehabilitation (IPR). Eligible participants will be started on autotitrating continuous positive airway pressure (CPAP) therapy and exposed to a multicomponent adherence intervention, beginning during IPR and extending for 3 months. Input regarding the intervention will be sought from the participants, CPAP partners, and the research team implementing the intervention. Data from an initial group of participants will be reviewed, and adaptations will be implemented within the next batch of participants. Through this iterative process, the behavioral intervention will be adapted for use among stroke patients. CPAP technical support intervention: SCOUTS 3 sleep technologists will make mask type/size or device adjustments, as needed, and provide training to participants and CPAP partners to improve skills involved with mask placement and device maintenance. Motivational Enhancement Therapy (MET): In-person Motivational Enhancement Therapy sessions by a trained sleep coach will occur within a week of starting CPAP and, with permission, conducted with a CPAP partner. Mobile Health intervention: Study participants will be assisted in registering for and trained on the ResMed myAir app. Participants will also receive mobile health messages based on Self-Determination Theory. | 0 | None | 0 | 36 | 0 | 36 | View |