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 |
|---|---|---|---|---|---|---|---|---|
| 18 mg BI 1015550 / 100 μg BI 1015550 (C-14) | One film-coated tablet of 18 milligram (mg) BI 1015550 was administered as single oral dose with 240 milliliter of water after an overnight fast of at least 10 hours on Day 1 as test treatment (T). 100 microgram (μg) BI 1015550 (C-14) solution (consisting of 90 μg unlabelled BI 1015550 mixed with 10 μg labelled \[14C\]-BI 1015550 in 10 mL intravenous solution with a final concentration of 10 μg BI 1015550 (C-14)/mL) was administered as single intravenous infusion over 15 minutes on Day 1 as reference treatment (R). The radioactive dose per infusion was \~40 kilobecquerel (kBq). | 0 | None | 0 | 8 | 0 | 8 | View |