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 @ 6:30 PM
Ignite Modification Date: 2025-12-25 @ 4:00 PM
NCT ID: NCT01812668
Description: None
Frequency Threshold: 5
Time Frame: All untoward events that occur after start of therapy through 30 days after the last dose of study treatment are to be recorded, about 12 months on average.
Study: NCT01812668
Study Brief: Cabozantinib-S-Malate in Treating Patients With Hormone-Resistant Metastatic Prostate 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
Treatment (Cabozantinib-s-malate) Patients receive cabozantinib-s-malate PO daily in the absence of disease progression or unacceptable toxicity. cabozantinib-s-malate: Given PO fluorine F 18 d-FMAU: Undergo 18F PET/FMAU PET scan positron emission tomography: Undergo 18F PET/FMAU PET scan pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies 18 None 4 20 20 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hand foot syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
urinary infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
elevated creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
decreased ALC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
GERD NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
UTI NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
anorexia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
blisters NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
chills NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
dysgeusia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
edema NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
hand/foot NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hoarseness NON_SYSTEMATIC_ASSESSMENT General disorders None View
hyperglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
increased ALT NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
increased AST NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
weakness NON_SYSTEMATIC_ASSESSMENT General disorders None View
weight loss NON_SYSTEMATIC_ASSESSMENT General disorders None View