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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | 1:1 randomization, given standard of care treatment during surgery, visual acuity exam Saline Solution: Placebo Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium. | 0 | None | 2 | 40 | 6 | 40 | View |
| Treatment | 1:1 randomization, given tranexamic acid during surgery, visual acuity exam Tranexamic Acid: Antifibrinolytic Agent Visual Acuity Exam: Supplemented into standard of care daily neurological exam on day of surgery and day after 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM): 3D-CAM is a brief verbal assessment tool that can be used to test patients and study patients for delirium. | 0 | None | 0 | 43 | 6 | 43 | View |