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 |
|---|---|---|---|---|---|---|---|---|
| 1 Coreg CR + Lisinopril | Coreg CR + lisinopril carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months | None | None | 0 | 31 | 0 | 31 | View |
| 2 Coreg CR + Placebo | Coreg CR + placebo carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months | None | None | 0 | 24 | 0 | 24 | View |
| 3 Lisinopril + Placebo | lisinopril + placebo lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months | None | None | 1 | 22 | 0 | 22 | View |
| 4 Placebo + Placebo | None | None | None | 0 | 24 | 0 | 24 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| stroke | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |