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 |
|---|---|---|---|---|---|---|---|---|
| Arm 1: IV Acetaminophen Group | Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule | 0 | None | 0 | 60 | 0 | 60 | View |
| Arm 2: PO Acetaminophen Group | Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention | 0 | None | 0 | 60 | 0 | 60 | View |