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 |
|---|---|---|---|---|---|---|---|---|
| Maraviroc + Raltegravir Intensification | ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks) | None | None | 1 | 14 | 0 | 14 | View |
| Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine | ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32) | None | None | 3 | 14 | 0 | 14 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| creatine kinase | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |