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 |
|---|---|---|---|---|---|---|---|---|
| Air Filtration Unit Treatment (Tx2) | A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove. Air Filtration Unit Treatment (Tx2): A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove | 0 | None | 0 | 47 | 0 | 47 | View |
| Placebo Intervention (Tx3) | A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter. Placebo Intervention (Tx3): A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter. | 0 | None | 0 | 47 | 0 | 47 | View |
| Education (Tx1) | Education on best burn practices Education (Tx1): Education on best burn practices | 0 | None | 0 | 49 | 0 | 49 | View |