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 |
|---|---|---|---|---|---|---|---|---|
| US Guided Single Shot Paravertebral Block | group 1- US Guided Single Shot Paravertebral Block US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery. | 0 | None | 0 | 40 | 0 | 40 | View |
| Thoracic Epidural | group 3- Thoracic Epidural Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery. | 0 | None | 0 | 40 | 0 | 40 | View |
| US Guided Paravertebral Catheter | group 2- US Guided Paravertebral Catheter US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery. | 0 | None | 0 | 40 | 0 | 40 | View |