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 |
|---|---|---|---|---|---|---|---|---|
| PCA3 Assay | PCA3 Assay : Post-DRE urine collected prior to prostate biopsy | None | None | 0 | 498 | 0 | 498 | View |
| Subjects With Negative Biopsy Result | Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results) | None | None | 0 | 389 | 0 | 389 | View |
| Subjects With no Biopsy Performed | None | None | None | 0 | 3 | 0 | 3 | View |
| Subjects With Positive Biopsy Result | Presence of prostate cancer defined by one or more positive biopsy cores | None | None | 0 | 106 | 0 | 106 | View |