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 @ 7:39 PM
Ignite Modification Date: 2025-12-25 @ 5:19 PM
NCT ID: NCT03650803
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were monitored through study completion, up to 6 months for each enrolled patient.
Study: NCT03650803
Study Brief: Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Breast Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
3D MR Fingerprinting Scan Three separate 3D MR fingerprinting scans: Before the start of chemotherapy, 7-10 days after the first cycle of chemotherapy, and within 1 month of the end of chemotherapy treatment. 3D MR Fingerprinting scan: 3D MR Fingerprinting technique is a non-contrast technique and generates quantitative information about MR-visible tumors without having to administer contrast. MR Fingerprinting software is used in conjunction with a standard-of-care MRI scan. 0 None 0 14 1 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nervous system disorders, Other: MRI exacerbated pre-existing Menier's Disease SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v5.0 View