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 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 10:55 PM
NCT ID: NCT02180867
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: Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
Study: NCT02180867
Study Brief: Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dose-Finding Level 2 RT Dose-Finding Level 2 RT: Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2 3 None 2 10 5 10 View
Regimen A Regimen A: Chemoradiation plus pazopanib 5 None 33 46 20 46 View
Regimen B Regimen B: Chemoradiation alone 9 None 8 43 10 43 View
Regimen C Regimen C: Radiation therapy plus pazopanib 0 None 1 6 1 6 View
Regimen D Regimen D: Radiation therapy alone 2 None 0 6 0 6 View
Dose-Finding Level 1 CR Dose-Finding Level 1 CR: Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2 1 None 6 9 4 9 View
Dose-Finding Level 1 RT Dose-Finding Level 1 RT: Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2 4 None 6 9 2 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv5 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Perforation bile duct SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCv5 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv5 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv5 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv5 View
Blood and lymphatic system disorders - Other, specify SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv5 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCv5 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCv5 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv5 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Laryngospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCv5 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders CTCv5 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCv5 View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCv5 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv5 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCv5 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Uterine hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCv5 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCv5 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Postoperative hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders CTCv5 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Radiation recall reaction (dermatologic) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv5 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCv5 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCv5 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCv5 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCv5 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCv5 View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCv5 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCv5 View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations CTCv5 View