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 |
|---|---|---|---|---|---|---|---|---|
| Subtrochanteric Femoral Fractures | Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375% Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375% Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375% | 0 | None | 0 | 3 | 0 | 3 | View |
| Intertrochanteric Femoral Fractures | Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375% Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375% Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375% | 6 | None | 21 | 42 | 0 | 42 | View |
| Neck Femur Fractures | Ropivacaine (sciatic nerve block): injection of 20 ml ropivacaine 0.375% Ropivacaine (lumbar plexus block L2-L4): injection of 20 ml ropivacaine 0.375% Ropivacaine (lumbar plexus block Th12-L1): injection of 20 ml ropivacaine 0.375% | 3 | None | 16 | 33 | 0 | 33 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| epidural anesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| delirium | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| ventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| hematoma | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| heart failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| wound infection | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |