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 |
|---|---|---|---|---|---|---|---|---|
| COLPOSCOPY | Women with ASC-US cytology are immediately refer to colposcopy COLPOSCOPY: Colposcopy routine health services | 0 | None | 0 | 882 | 0 | 882 | View |
| CYTOLOGY | Women with ASC-US Cytology are follow-up with cytology at 6 and/or 12 months and be referred to colposcopy if any of these cytologies is ASC-US or higher COLPOSCOPY: Colposcopy routine health services cytology: Cytology routine health services | 0 | None | 0 | 890 | 0 | 890 | View |
| HPV Test | Women with ASC-US cytology are HPV tested and those HPV positive are refer to Colposcopy HPV test: QIAGEN - The Digene HPV test® COLPOSCOPY: Colposcopy routine health services | 0 | None | 0 | 889 | 0 | 889 | View |