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 |
|---|---|---|---|---|---|---|---|---|
| NDURE | NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE consists of 6 key functions including (1) Improve patient knowledge about Guidelines for timely PORT and associated care processes: (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patient and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each. The three NDURE sessions coincide with the pre-surgical consult, hospital discharge, and first postoperative visit, time points chosen to facilitate case identification and coordination across care transitions. During each NDURE session, the navigator delivers patient education and creates or updates the PORT Care Plan. Referral tracking and follow-up occurs through asynchronous contact between the navigator, patient, and healthcare organizations between NDURE sessions. | 1 | None | 0 | 15 | 0 | 15 | View |