Adverse Events Module

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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

Ignite Creation Date: 2025-12-24 @ 11:42 PM
Ignite Modification Date: 2025-12-25 @ 9:34 PM
NCT ID: NCT03000751
Description: Adverse event data were not reported in this study. Study data were collected from consecutive patients who underwent a standard of care procedure (CT imaging). No tests, treatments, or interactions with any patients were performed as part of this study. There was no way to capture, nor any need to capture for the purpose of our research, adverse events related to their imaging procedures.
Frequency Threshold: 0
Time Frame: Adverse events were not collected.
Study: NCT03000751
Study Brief: CT DOSE Collaboratory
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Track A Simple Audit Report In-Person Meeting Multi-Component Intervention Simple Audit Report: The simple audit provides comparison and feedback on radiation doses. Multi-Component Intervention: The multi-component intervention gives tailored feedback on needed changes plus guidance using quality improvement methods that facilitate organizational change. Provides access to experts, detailed audit, collaborative calls, and site visits (as needed). In-Person Meeting: Collaborator meeting with an emphasis on quality improvement. 0 None 0 0 0 0 View
Track B Simple Audit Report In-Person Meeting Multi-Component Intervention Simple Audit Report: The simple audit provides comparison and feedback on radiation doses. Multi-Component Intervention: The multi-component intervention gives tailored feedback on needed changes plus guidance using quality improvement methods that facilitate organizational change. Provides access to experts, detailed audit, collaborative calls, and site visits (as needed). In-Person Meeting: Collaborator meeting with an emphasis on quality improvement. 0 None 0 0 0 0 View
Track C Simple Audit Report Multi-Component Intervention Simple Audit Report: The simple audit provides comparison and feedback on radiation doses. Multi-Component Intervention: The multi-component intervention gives tailored feedback on needed changes plus guidance using quality improvement methods that facilitate organizational change. Provides access to experts, detailed audit, collaborative calls, and site visits (as needed). 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):