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 |
|---|---|---|---|---|---|---|---|---|
| Standard Neuromuscular Blockade | Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo). Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo). | None | None | 0 | 63 | 0 | 63 | View |
| Deep Neuromuscular Blockade | Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment. Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment. | None | None | 0 | 65 | 0 | 65 | View |