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 |
|---|---|---|---|---|---|---|---|---|
| Single Arm Assignment | Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days). Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose. | None | None | 0 | 1 | 1 | 1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| DIARRHEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| TASTE ALTERATION (DYSGEUSIA) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |