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 |
|---|---|---|---|---|---|---|---|---|
| Tobramycin Inhaled Solution | Before and after study of patients with cystic fibrosis and Pseudomonas colonization comparing the time spent with TOBIsolutions vs TOBIpodhaler. The preference was evaluated including changing lung function over the course of the study. | 0 | None | 0 | 5 | 0 | 5 | View |
| TOBI Podhaler | patient with cystic fibrosis using TOBI podhaler treatment. | 0 | None | 0 | 5 | 0 | 5 | View |