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 |
|---|---|---|---|---|---|---|---|---|
| Dasatinib, 100 mg as Liquid + Water | Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period. | None | None | 0 | 77 | 44 | 77 | View |
| Dasatinib, 100 mg as Tablets in Orange Juice + Water | Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. | None | None | 0 | 77 | 35 | 77 | View |
| Dasatinib, 100 mg as Tablets + Water | Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period. | None | None | 0 | 78 | 42 | 78 | View |