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: 2025-12-25 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT04150705
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected for a period of 24 hours following the administration of the radiotracer FDG.
Study: NCT04150705
Study Brief: PET/MR for Rectal Cancer Treatment Monitoring and Surveillance
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FDG PET/MRI -Patients will undergo FDG-PET/MRI in lieu of the standard pelvic MRI at up to 6 time-points at which it would normally be performed in their care for the period of time extending 30-36 months from the time of enrollment (depending on enrollment point). In the surveillance period, when patients typically undergo pelvic MRI every 3 months, the FDG-PET/MRI will be done in lieu of the standard pelvic MRI on an approximately every-other-scan basis. In other words, the FDG-PET/MRI will occur roughly once every 6 months. 0 None 0 14 2 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (Unspecified) View