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 |
|---|---|---|---|---|---|---|---|---|
| Midazolam + Ketamine 10 mg | Drug: Ketamine 10 MG/ML: 1 ML Ketamine 10 MG/ML: 1 ML: 10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case. | None | None | 0 | 35 | 0 | 35 | View |
| Midazolam Alone | Drug: Titrated midazolam + normal saline placebo Normal saline: Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case. | None | None | 0 | 41 | 0 | 41 | View |
| Midazolam + Ketamine 5 mg | Drug: Ketamine 10 MG/ML: 0.5 ML Ketamine 10 MG/ML: 0.5 ML: 5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case. | None | None | 0 | 29 | 0 | 29 | View |