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 @ 3:52 PM
Ignite Modification Date: 2025-12-25 @ 1:58 PM
NCT ID: NCT02867592
Description: Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Frequency Threshold: 0
Time Frame: From start of treatment to 30 days after last dose, a median of 3.4 months
Study: NCT02867592
Study Brief: Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ewing's Sarcoma Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 12 None 6 13 5 13 View
Rhabdomyosarcoma Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 10 None 2 13 7 13 View
Non-Rhabdomyosarcoma Soft Tissue Sarcoma Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 8 None 4 13 7 13 View
Wilms Tumor Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 10 None 6 13 7 13 View
Rare Tumors Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 18 None 10 23 13 23 View
Osteosarcoma Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 20 None 8 29 17 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Death NOS SYSTEMATIC_ASSESSMENT General disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac 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
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations None View
Metabolism and nutrition disorders - Other, specify SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nervous system disorders - Other, specify SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Leukemia secondary to oncology chemotherapy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pericardial tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left ventricular systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Esophageal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Localized edema SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Dysesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema face SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia 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
Lipase increased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nervous system disorders - Other, specify SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Serum amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
GGT increased SYSTEMATIC_ASSESSMENT Investigations None View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations None View