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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT00672594
Description: The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
Frequency Threshold: 0
Time Frame: 4 years
Study: NCT00672594
Study Brief: Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
50 mg Sunitinib Malate Only study arm; treatment arm. Sunitinib Malate : 50mg daily x 4 weeks None None 0 30 29 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Anal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Facial pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Infections and infestations - Other, sinus SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Infections and infestations - Other, urinary SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Periorbital edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Scalp pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin and subcutaneous tissue disorders - Other, hair depigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin and subcutaneous tissue disorders - Other, subungual splinter hemorrhage SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin and subcutaneous tissue disorders - Other, yellowing skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View