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 @ 2:31 PM
Ignite Modification Date: 2025-12-25 @ 1:04 PM
NCT ID: NCT04252859
Description: None
Frequency Threshold: 0
Time Frame: Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
Study: NCT04252859
Study Brief: [18F]Fluoroestradiol-PET/CT Imaging of Invasive Lobular Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pilot Phase Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan and one optional 18F-FDG PET/CT(if a standard of care scan not already performed). For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection. For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection. \[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC) 0 None 0 17 7 17 View
Expansion Phase Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT. For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection. For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection. \[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC) 0 None 0 25 0 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Belching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View