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 |
|---|---|---|---|---|---|---|---|---|
| Platelet Rich Plasma | At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle. Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle. Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles. Arthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-s | 0 | None | 4 | 5 | 1 | 5 | View |
| Saline | At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle. Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle. Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles. Arthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation | 0 | None | 0 | 6 | 1 | 6 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infection | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hardware Loosening | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Painful Implants | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Post-traumatic Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |