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 |
|---|---|---|---|---|---|---|---|---|
| TAK-906 Maleate 25 mg | TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period. | 0 | None | 0 | 12 | 0 | 12 | View |
| Itraconazole 200 mg | Itraconazole 200 mg, solution, orally, once daily on Days 1 to 3 of Second Intervention Period. | 0 | None | 0 | 11 | 1 | 11 | View |
| Itraconazole 200 mg + TAK-906 Maleate 25 mg | Itraconazole 200 mg, solution, orally, once daily on Days 4 and 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period. | 0 | None | 0 | 11 | 1 | 11 | View |