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 |
|---|---|---|---|---|---|---|---|---|
| 14C-Nemi Oral | Participants received solution of \[14C\] radiolabelled GSK2269557 as a single dose of 800 µg orally | 0 | None | 0 | 6 | 1 | 6 | View |
| Nemi IH + 14C-Nemi IV | Participants received IV infusion of \[14C\] radiolabeled GSK2269557 as a single dose of 10 µg administered as single microtracer, concomitantly with an inhaled non-radiolabeled 1000 µg dose of GSK2269557. | 0 | None | 0 | 6 | 0 | 6 | View |