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 |
|---|---|---|---|---|---|---|---|---|
| Early Intervention / Retention Group, Residents | Residents in the Early Intervention Group undergo baseline assessment at period 1 (0 months) followed by the PACTS curriculum, with subsequent assessment at period 2 (18 months) and period 3 (36 months). PACTS curriculum: The cultural dexterity curriculum, known as PACTS (Provider Awareness Cultural Dexterity Toolkit for Surgeons) focuses on developing cognitive skills to adapt to individual patients' needs to ensure personal, patient-centered surgical care. The curriculum is comprised of four educational modules on establishing trust in the physician-patient relationship, communicating effectively with patients with limited English proficiency, discussing informed consent, and issues surrounding pain management. Each module consists of an independent learning activity, an interactive role-play, and a post-lesson assessment. | 0 | None | 0 | 192 | 0 | 192 | View |
| Delayed Intervention Group, Residents | Residents in the Delayed Intervention Group undergo baseline assessment at period 1 (0 months) followed by the standard curriculum, with subsequent assessment at period 2 (18 months). They then receive the PACTS curriculum with subsequent evaluation at period 3 (36 months). PACTS curriculum: The cultural dexterity curriculum, known as PACTS (Provider Awareness Cultural Dexterity Toolkit for Surgeons) focuses on developing cognitive skills to adapt to individual patients' needs to ensure personal, patient-centered surgical care. The curriculum is comprised of four educational modules on establishing trust in the physician-patient relationship, communicating effectively with patients with limited English proficiency, discussing informed consent, and issues surrounding pain management. Each module consists of an independent learning activity, an interactive role-play, and a post-lesson assessment. | 0 | None | 0 | 214 | 0 | 214 | View |
| Early Intervention Group, Patients | This corresponds to patients who were cared for by residents who were designated to the Early Intervention Group. | 0 | None | 0 | 1297 | 0 | 1297 | View |
| Delayed Intervention Group, Patients | This corresponds to patients who were cared for by residents who were designated to the Delayed Intervention Group. | 0 | None | 0 | 1198 | 0 | 1198 | View |