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 |
|---|---|---|---|---|---|---|---|---|
| nCAP + ERAS | Participants will have the nCAP Signal Relief Patch and complete Enhanced Recovery After Surgery (ERAS) standard of care. After surgery, the subjects randomized to the intervention group will have the nCAP Signal Relief patch applied to their surgical dressing by a trained researcher in the immediate Post Anesthesia Care Unit (PACU). nCAP Signal Relief Patch: nCAP Signal Relief Patch post-operatively applied to the subject's surgical dressing by a trained researcher in the immediate Post Anesthesia Care Unit (PACU) Standard of Care: Subjects will undergo surgery using the approved ERAS anesthetic and post-operative pain management protocols. At Shadyside Hospital, the ERAS Protocol for these subjects involves preoperative meloxicam 15mg PO, gabapentin 300mg PO, acetaminophen 1g PO. Intra-operative, patients receive a spinal block (bupivacaine) and propofol IV sedation. Postoperative pain medication is titrated to the individual patient's level of pain (0-10). 0.2 mg IV hydromorphone can be given for breakthrough pain, oxycodone 5mg PO for moderate pain (4-6) and oxycodone 10 mg PO for severe pain (7-10). Ketorolac 15 mg IV is given Q6H during the hospital stay. Discharge medication may be Norco 5-325mg as prescribed by the surgeon. | 0 | None | 0 | 38 | 0 | 38 | View |
| ERAS Alone | Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no nCAP patch. Standard of Care: Subjects will undergo surgery using the approved ERAS anesthetic and post-operative pain management protocols. At Shadyside Hospital, the ERAS Protocol for these subjects involves preoperative meloxicam 15mg PO, gabapentin 300mg PO, acetaminophen 1g PO. Intra-operative, patients receive a spinal block (bupivacaine) and propofol IV sedation. Postoperative pain medication is titrated to the individual patient's level of pain (0-10). 0.2 mg IV hydromorphone can be given for breakthrough pain, oxycodone 5mg PO for moderate pain (4-6) and oxycodone 10 mg PO for severe pain (7-10). Ketorolac 15 mg IV is given Q6H during the hospital stay. Discharge medication may be Norco 5-325mg as prescribed by the surgeon. | 0 | None | 0 | 31 | 0 | 31 | View |