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 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:30 PM
NCT ID: NCT01834651
Description: Attributions and ratings completed by Investigators as per CTCAE
Frequency Threshold: 5
Time Frame: From signed consent up to 30 days after last treatment
Study: NCT01834651
Study Brief: A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases
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) Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression. None None 14 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chest Pain- Cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry nose SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fecal Incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hot Flashes SYSTEMATIC_ASSESSMENT General disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nail Changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Skin Friable SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
ALT increased SYSTEMATIC_ASSESSMENT Investigations None View
AST increased SYSTEMATIC_ASSESSMENT Investigations None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Activated PTT prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline Phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Allergic Rhinitis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anasarca SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bacterial Overgrowth SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations None View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Corneal Epithelial Defect SYSTEMATIC_ASSESSMENT Eye disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Dysguesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Inflamed eyelids SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Facial Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gastroesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GGT Increased SYSTEMATIC_ASSESSMENT Investigations None View
Genital Edema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Gynecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hair Color Change SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hot Cold SYSTEMATIC_ASSESSMENT General disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Lipase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Localized edema - bilateral leg SYSTEMATIC_ASSESSMENT General disorders None View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Mucositis Oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nasal Discharge SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nervous system disorders other, T5 - T9 co SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Oculomotor Nerve Disorder (3rd Nervepalsy) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Osteonecrosis of Jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain (Pain in Jaw) SYSTEMATIC_ASSESSMENT General disorders None View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Palmar-Plantar Erythrodysesthesia Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric disorders - Other, Nightmares SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal Fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Right Foot Drop SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Scalp Follicullitos SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Serum Amylase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Skin discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Stool Color Change SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Surgical and medical procedures- Herniorrhaphy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
TMJ SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vision Change SYSTEMATIC_ASSESSMENT Eye disorders None View
Voice Alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vomiting (Intermittent) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Watering Eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
White Blood Cell Decreased SYSTEMATIC_ASSESSMENT Investigations None View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
proteinuria SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View