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 |
|---|---|---|---|---|---|---|---|---|
| PSG CPAP Titration Then CPAP Treatment | Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration | None | None | 0 | 78 | 19 | 78 | View |
| Auto-Adjusting Positive Airway Pressure | Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O) | None | None | 0 | 78 | 12 | 78 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| PAP treatment intolerance | NON_SYSTEMATIC_ASSESSMENT | General disorders | PAP intolerance | View |