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 @ 12:53 AM
Ignite Modification Date: 2025-12-25 @ 11:09 PM
NCT ID: NCT04410367
Description: None
Frequency Threshold: 0
Time Frame: Safety was assessed from the time of 18F-fluciclovine administration until 1 day post18Ffluciclovine administration based on reported adverse events (AEs) and serious adverse events (SAEs); treatment emergent adverse events (TEAE).
Study: NCT04410367
Study Brief: Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
18F-Fluciclovine Injection Subjects who have been dosed with 18F-Fluciclovine, have an evaluable on-study PET scan, and an evaluable central histopathology report from the sample obtained from the SoC craniotomy. 0 None 0 23 1 23 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View