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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Standard Neuromuscular Blockade | Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions | 0 | None | 24 | 361 | 65 | 361 | View |
| Deep Neuromuscular Block | Subjects will receive high dose rocuronium induction dose followed by continuous rocuronium administration, to achieve a depth of neuromuscular block of 1-2 twitches post tetanic count Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count | 0 | None | 23 | 362 | 51 | 362 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Unplanned readmission | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| postoperative nausea vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |