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 |
|---|---|---|---|---|---|---|---|---|
| C Group | normal thermal condition with core temperatures between 36.5°C and 37°C sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state Reversal effect of sugammadex in temperature state | None | None | 0 | 30 | 0 | 30 | View |
| H Group | mild hypothermia with core temperatures between 34.5°C and 35°C sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state Reversal effect of sugammadex in temperature state | None | None | 0 | 30 | 0 | 30 | View |