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 |
|---|---|---|---|---|---|---|---|---|
| Perindopril | 4 mg qd titrated to 8 mg qd perindopril + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking Perindopril: 4 mg qd titrated to 8 mg qd perindopril | 0 | None | 2 | 74 | 32 | 74 | View |
| Losartan | 50 mg qd titrated to 100 mg qd losartan + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking Losartan: 50 mg qd titrated to 100 qd losartan | 0 | None | 1 | 74 | 31 | 74 | View |
| HCTZ | 12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking HCTZ: 12.5 mg qd titrated to 25 qd HCTZ | 0 | None | 5 | 75 | 40 | 75 | View |