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 |
|---|---|---|---|---|---|---|---|---|
| Navify Oncology Hub | We will first conduct a small number of simulation sessions (3-5) to validate study methods and data collection procedures. Study methods may then be refined before conducting simulation sessions with a larger number of participants (approx. 25). In this phase, each participant will participate in a 90-minute simulation session in which they will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting. NAVIFY Oncology Hub: NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly. | 0 | None | 0 | 27 | 0 | 27 | View |