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 |
|---|---|---|---|---|---|---|---|---|
| Breathes Program | Participants will participate in the at-home BREATHES program which will consist of a video education module and using a hand-held spirometry device, SpiroPD. BREATHES Program: Participants will complete inhaler education using the virtual education module at the baseline visit of the study. Additionally, they will be asked to complete the lesson at least once before their 30 day follow-up visit on their personal device once they have been discharged from the hospital. BREATHES SpiroPD or Propeller Health: At the time of their initial study visit, study participants may be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal. A small device will be attached to track real-time medication use. | 0 | None | 0 | 70 | 0 | 70 | View |