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 |
|---|---|---|---|---|---|---|---|---|
| Aim 1 Cohort: MESA | This cohort includes biospecimens collected from 1852 participants in the MESA sleep study \[Chen et al\]. Serum biomarkers were measured by immunoassay in the Laboratory for Clinical Biochemistry Research at the University of Vermont. | 0 | None | 0 | 1852 | 0 | 1852 | View |
| Aim 2 Cohort: HeartBEAT and BestAir | This cohort includes 62 men and 20 women with newly diagnosed moderate-to-severe OSA and without known severe lung disease, who had participated in either of two randomized trials of PAP therapy, the HeartBEAT \[Gottlieb et al\] and BestAIR \[Bakker et al\] studies. Participants were selected for this analysis based on mean PAP adherence of =4 hours daily over a follow-up period of 3 months in the HeartBEAT study and 6 months in the BestAIR study. Morning serum samples drawn at baseline and at the end of the PAP treatment period were assayed using commercially available ELISA for each biomarker in the Laboratory for Clinical Biochemistry Research at the University of Vermont Larner College of Medicine. | 0 | None | 0 | 82 | 0 | 82 | View |
| Aim 3b Cohort: ILD Screening for OSA | Participants with ILD will be screened for OSA by polysomnography. | 0 | None | 0 | 0 | 0 | 0 | View |
| Aim 3a Cohort: CPAP Treatment of OSA | Participants with OSA will be treated with CPAP. | 0 | None | 0 | 87 | 0 | 87 | View |