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 @ 4:03 AM
Ignite Modification Date: 2025-12-26 @ 2:58 AM
NCT ID: NCT01720602
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01720602
Study Brief: Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Hormone Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Vorinostat, AI Therapy) Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. vorinostat: Given PO anastrozole: Given PO letrozole: Given PO exemestane: Given PO positron emission tomography: Correlative studies F-18 16 alpha-fluoroestradiol: Correlative studies fludeoxyglucose F 18: Correlative studies laboratory biomarker analysis: Correlative studies None None 2 15 8 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Liver failure None Hepatobiliary disorders None View
Fever None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
diarrhea None Gastrointestinal disorders None View
nausea None Gastrointestinal disorders None View
neutropenia None Blood and lymphatic system disorders None View
Rigors / chills None General disorders None View
Dizziness None Nervous system disorders None View
decrease in glomerular filtration None Renal and urinary disorders None View
creatinine increase None Renal and urinary disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
vomiting None Gastrointestinal disorders None View
Muscle cramps None Musculoskeletal and connective tissue disorders None View