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 |
|---|---|---|---|---|---|---|---|---|
| Active-CPAP | Patients assigned to active-CPAP were treated with auto-titrating CPAP, where an auto-titrator adjusted the delivered pressure between 4 to 20 cm of water to eliminate obstructive events for a goal apnea-hypopnea index less than or equal to 5. Auto-titrating CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly to document adherence and address issues arising at night. A sleep technologist also met with patients at least twice weekly to monitor safety and adverse events and make any adjustments to the CPAP mask or machine. Efforts to improve adherence to CPAP for patients treated with active-CPAP included education, desensitization of CPAP through daytime use, adjustments of humidity and mask (including addition of a chin strap), decreasing CPAP maximum pressure and use of expiratory pressure relief (CFlex) for patients treated with active-CPAP. | None | None | 0 | 20 | 0 | 20 | View |
| Sham-CPAP | The sham-CPAP device in our study was designed to entail no risks beyond those with standard CPAP and provide a high level of blinding. The sham-CPAP device has an internal flow restrictor and a modified elbow attached to the nasal mask. The elbow modification delivers a pressure at the mask in¬terface of roughly 0.75 to 1 cm water and is not noticeable when the device is fully assembled to avoid the possibility of unblinding patients, providers, or study personnel. Sham-CPAP was initiated after admission to the rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. Respiratory therapist visited patients nightly to address issues arising at night. A sleep technologist also met with patients at least twice weekly to make any adjustments to the mask or machine. Efforts to improve adherence to CPAP for patients treated with sham-CPAP included patient education, desensitization of CPAP through daytime use and adjustments of humidity and mask. | None | None | 0 | 20 | 0 | 20 | View |