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 |
|---|---|---|---|---|---|---|---|---|
| Patient-Controlled Epidural Analgesia | Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours Bupivacaine: Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter Fentanyl: Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine. | 0 | None | 0 | 19 | 0 | 19 | View |
| Intravenous Patient-controlled Analgesia | Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone Hydromorphone: Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL). | 0 | None | 0 | 21 | 0 | 21 | View |