Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 1:11 AM
Ignite Modification Date: 2025-12-25 @ 11:22 PM
NCT ID: NCT00061893
Description: By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.
Frequency Threshold: 0
Time Frame: None
Study: NCT00061893
Study Brief: Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of 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
Combination Chemotherapy Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease. None None 33 35 34 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain None Gastrointestinal disorders None View
Activated partial thromboplastin time prolonged None Investigations None View
Adult respiratory distress syndrome None Respiratory, thoracic and mediastinal disorders None View
Alanine aminotransferase increased None Investigations None View
Anemia None Blood and lymphatic system disorders None View
Anorexia None Metabolism and nutrition disorders None View
Aspartate aminotransferase increased None Investigations None View
Back pain None Musculoskeletal and connective tissue disorders None View
Bladder infection None Infections and infestations None View
Bladder spasm None Renal and urinary disorders None View
Blood bilirubin increased None Investigations None View
Bronchial infection None Infections and infestations None View
Catheter related infection None Infections and infestations None View
Colitis None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Cystitis noninfective None Renal and urinary disorders None View
Dehydration None Metabolism and nutrition disorders None View
Diarrhea None Gastrointestinal disorders None View
Dysphagia None Gastrointestinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Electrocardiogram QT corrected interval prolonged None Investigations None View
Esophagitis None Gastrointestinal disorders None View
Fatigue None General disorders None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Fever None General disorders None View
Fibrinogen decreased None Investigations None View
Forced expiratory volume decreased None Investigations None View
Gastritis None Gastrointestinal disorders None View
Gastrointestinal disorders - Other, specify None Gastrointestinal disorders None View
GGT increased None Investigations None View
Hematuria None Renal and urinary disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hyperkalemia None Metabolism and nutrition disorders None View
Hypermagnesemia None Metabolism and nutrition disorders None View
Hypernatremia None Metabolism and nutrition disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hypomagnesemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Hypotension None Vascular disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Ileus None Gastrointestinal disorders None View
Infections and infestations - Other, specify None Infections and infestations None View
Intra-abdominal hemorrhage None Gastrointestinal disorders None View
Lung infection None Infections and infestations None View
Lymphocyte count decreased None Investigations None View
Mucositis oral None Gastrointestinal disorders None View
Myocardial infarction None Cardiac disorders None View
Nausea None Gastrointestinal disorders None View
Neutrophil count decreased None Investigations None View
Pain of skin None Skin and subcutaneous tissue disorders None View
Pericardial effusion None Cardiac disorders None View
Perineal pain None Reproductive system and breast disorders None View
Peripheral motor neuropathy None Nervous system disorders None View
Peripheral sensory neuropathy None Nervous system disorders None View
Pharyngeal mucositis None Respiratory, thoracic and mediastinal disorders None View
Platelet count decreased None Investigations None View
Pleural hemorrhage None Respiratory, thoracic and mediastinal disorders None View
Pneumonitis None Respiratory, thoracic and mediastinal disorders None View
Pulmonary hypertension None Respiratory, thoracic and mediastinal disorders None View
Sepsis None Infections and infestations None View
Upper gastrointestinal hemorrhage None Gastrointestinal disorders None View
Upper respiratory infection None Infections and infestations None View
Urinary retention None Renal and urinary disorders None View
Urinary tract infection None Infections and infestations None View
Vascular access complication None Injury, poisoning and procedural complications None View
Vasovagal reaction None Nervous system disorders None View
Vomiting None Gastrointestinal disorders None View
Weight loss None Investigations None View
White blood cell decreased None Investigations None View
Wound infection None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acidosis None Metabolism and nutrition disorders None View
Activated partial thromboplastin time prolonged None Investigations None View
Alanine aminotransferase increased None Investigations None View
Anemia None Blood and lymphatic system disorders None View
Aspartate aminotransferase increased None Investigations None View
Bladder spasm None Renal and urinary disorders None View
Blood bilirubin increased None Investigations None View
Burn None Injury, poisoning and procedural complications None View
Catheter related infection None Infections and infestations None View
Constipation None Gastrointestinal disorders None View
Depression None Psychiatric disorders None View
Gastritis None Gastrointestinal disorders None View
Gastrointestinal disorders - Other, specify None Gastrointestinal disorders None View
Hematuria None Renal and urinary disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypermagnesemia None Metabolism and nutrition disorders None View
Hypertension None Vascular disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Infections and infestations - Other, specify None Infections and infestations None View
INR increased None Investigations None View
Intra-abdominal hemorrhage None Gastrointestinal disorders None View
Mucositis oral None Gastrointestinal disorders None View
Peripheral motor neuropathy None Nervous system disorders None View
Peripheral sensory neuropathy None Nervous system disorders None View
Proctitis None Gastrointestinal disorders None View
Proteinuria None Renal and urinary disorders None View
Psychosis None Psychiatric disorders None View
Radiation recall reaction (dermatologic) None Injury, poisoning and procedural complications None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Thromboembolic event None Vascular disorders None View
Urinary frequency None Renal and urinary disorders None View
Urinary tract infection None Infections and infestations None View
Urinary tract pain None Renal and urinary disorders None View
Vomiting None Gastrointestinal disorders None View