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 |
|---|---|---|---|---|---|---|---|---|
| No Neuromuscular Blockade | Anesthesia will be administered in a standard fashion. Rocuronium and sugammadex will not be administered. SOC drugs: 1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery. 2. Sevoflurane induction and maintenance of anesthesia 3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop 4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop 5. Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses). 6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop 7. Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours. Device monitoring: 1. Bispectral index system intraop 2. ExSpiron respiratory volume monitor intraop and in PACU Anesthesia without neuromuscular blockade: Anesthesia without rocuronium or sugammadex | 0 | None | 0 | 86 | 1 | 86 | View |
| Neuromuscular Blockade | Rocuronium 0.6 mg/kg IV (max 50 mg) intraop with repeated doses of 0.2 mg/kg (max 15 mg) as indicated. Sugammadex 2-4 mg/kg IV at the end of surgery. SOC drugs: 1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery. 2. Sevoflurane induction and maintenance 3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop 4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop 5. Fentanyl at the discretion of anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses). 6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop 7. Ibuprofen 10 mg/kg (max 500 mg) PO alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours after surgery. Monitoring: 1. Bispectral index system 2. TetraGraph neuromuscular transmission monitor 3. ExSpiron respiratory volume monitor in PACU Rocuronium: After induction of anesthesia and IV placement, administration of rocuronium 0.6 mg/kg (max 50 mg). Administration of additional doses of 0.2 mg/kg (max 15 mg) when TetraGraph indicates a train of four count of 2 or greater. Sugammadex: Administration of sugammadex 2 mg/kg at the end of surgery if the TetraGraph indicates the train of four count is 2 or greater. Sugammadex 4 mg/kg will be administered if 1) the train of four count is 1, or 2) if the train of four count is 0 and the post tetanic count is at least 1. There is no maximum dose of sugammadex. | 0 | None | 0 | 86 | 1 | 86 | View |