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 @ 12:21 AM
Ignite Modification Date: 2025-12-25 @ 10:25 PM
NCT ID: NCT00082758
Description: Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Frequency Threshold: 5
Time Frame: Duration of protocol therapy
Study: NCT00082758
Study Brief: hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Disease Measurable by Standard Criteria(hu14.18-interleukin-2) Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. hu14.18-Interleukin-2 fusion protein : Given IV None None 13 15 13 15 View
Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology. hu14.18-Interleukin-2 fusion protein : Given IV None None 21 24 18 24 View
Disease Identified by BM Immunohistochemistry Only Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (\>5 neuroblastoma cells per 1,000,000 nucleated marrow cells). hu14.18-Interleukin-2 fusion protein : Given IV None None 0 0 0 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders CTCv4 View
Febrile neutropenia None Blood and lymphatic system disorders CTCv4 View
Hearing impaired None Ear and labyrinth disorders CTCv4 View
Abdominal pain None Gastrointestinal disorders CTCv4 View
Death NOS None General disorders CTCv4 View
Anaphylaxis None Immune system disorders CTCv4 View
Bone infection None Infections and infestations CTCv4 View
Catheter related infection None Infections and infestations CTCv4 View
Infections and infestations None Infections and infestations CTCv4 View
Lung infection None Infections and infestations CTCv4 View
Tooth infection None Infections and infestations CTCv4 View
Alanine aminotransferase None Investigations CTCv4 View
Aspartate aminotransferase None Investigations CTCv4 View
Blood bilirubin increased None Investigations CTCv4 View
GGT increased None Investigations CTCv4 View
Lymphocyte count decrease None Investigations CTCv4 View
Neutrophil count decreased None Investigations CTCv4 View
Platelet count decreased None Investigations CTCv4 View
White blood cell decrease None Investigations CTCv4 View
Anorexia None Metabolism and nutrition disorders CTCv4 View
Dehydration None Metabolism and nutrition disorders CTCv4 View
Hyperglycemia None Metabolism and nutrition disorders CTCv4 View
Hypoalbuminemia None Metabolism and nutrition disorders CTCv4 View
Hypokalemia None Metabolism and nutrition disorders CTCv4 View
Hyponatremia None Metabolism and nutrition disorders CTCv4 View
Hypophosphatemia None Metabolism and nutrition disorders CTCv4 View
Dizziness None Nervous system disorders CTCv4 View
Agitation None Psychiatric disorders CTCv4 View
Pelvic pain None Reproductive system and breast disorders CTCv4 View
Cough None Respiratory, thoracic and mediastinal disorders CTCv4 View
Dyspnea None Respiratory, thoracic and mediastinal disorders CTCv4 View
Pleural effusion None Respiratory, thoracic and mediastinal disorders CTCv4 View
Pneumonitis None Respiratory, thoracic and mediastinal disorders CTCv4 View
Pruritus None Skin and subcutaneous tissue disorders CTCv4 View
Hypotension None Vascular disorders CTCv4 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Edema trunk None General disorders CTCv4 View
Fever None General disorders CTCv4 View
Localized edema None General disorders CTCv4 View
Otitis media None Infections and infestations CTCv4 View
Pharyngitis None Infections and infestations CTCv4 View
Sinusitis None Infections and infestations CTCv4 View
Upper respiratory infection None Infections and infestations CTCv4 View
Bruising None Injury, poisoning and procedural complications CTCv4 View
Alanine aminotransferase None Investigations CTCv4 View
Alkaline phosphatase increased None Investigations CTCv4 View
Aspartate aminotransferase None Investigations CTCv4 View
Blood bilirubin increased None Investigations CTCv4 View
Cholesterol high None Investigations CTCv4 View
Creatinine increased None Investigations CTCv4 View
GGT increased None Investigations CTCv4 View
Investigations - Other None Investigations CTCv4 View
Lymphocyte count decrease None Investigations CTCv4 View
Neutrophil count decreased None Investigations CTCv4 View
Platelet count decreased None Investigations CTCv4 View
Weight gain None Investigations CTCv4 View
White blood cell decrease None Investigations CTCv4 View
Acidosis None Metabolism and nutrition disorders CTCv4 View
Anorexia None Metabolism and nutrition disorders CTCv4 View
Dehydration None Metabolism and nutrition disorders CTCv4 View
Hypercalcemia None Metabolism and nutrition disorders CTCv4 View
Hyperglycemia None Metabolism and nutrition disorders CTCv4 View
Hyperkalemia None Metabolism and nutrition disorders CTCv4 View
Hypermagnesemia None Metabolism and nutrition disorders CTCv4 View
Hypernatremia None Metabolism and nutrition disorders CTCv4 View
Hypertriglyceridemia None Metabolism and nutrition disorders CTCv4 View
Hypoalbuminemia None Metabolism and nutrition disorders CTCv4 View
Hypocalcemia None Metabolism and nutrition disorders CTCv4 View
Hypoglycemia None Metabolism and nutrition disorders CTCv4 View
Hypokalemia None Metabolism and nutrition disorders CTCv4 View
Hypomagnesemia None Metabolism and nutrition disorders CTCv4 View
Hyponatremia None Metabolism and nutrition disorders CTCv4 View
Hypophosphatemia None Metabolism and nutrition disorders CTCv4 View
Bone pain None Musculoskeletal and connective tissue disorders CTCv4 View
Pain in extremity None Musculoskeletal and connective tissue disorders CTCv4 View
Intracranial hemorrhage None Nervous system disorders CTCv4 View
Anxiety None Psychiatric disorders CTCv4 View
Renal and urinary disorders, Other None Renal and urinary disorders CTCv4 View
Urinary retention None Renal and urinary disorders CTCv4 View
Allergic rhinitis None Respiratory, thoracic and mediastinal disorders CTCv4 View
Cough None Respiratory, thoracic and mediastinal disorders CTCv4 View
Dyspnea None Respiratory, thoracic and mediastinal disorders CTCv4 View
Epistaxis None Respiratory, thoracic and mediastinal disorders CTCv4 View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders CTCv4 View
Pleural effusion None Respiratory, thoracic and mediastinal disorders CTCv4 View
Respiratory, thoracic and mediastinal disorders, Other None Respiratory, thoracic and mediastinal disorders CTCv4 View
Voice alteration None Respiratory, thoracic and mediastinal disorders CTCv4 View
Alopecia None Skin and subcutaneous tissue disorders CTCv4 View
Dry skin None Skin and subcutaneous tissue disorders CTCv4 View
Pruritus None Skin and subcutaneous tissue disorders CTCv4 View
Rash maculo-papular None Skin and subcutaneous tissue disorders CTCv4 View
Flushing None Vascular disorders CTCv4 View
Hypertension None Vascular disorders CTCv4 View
Anemia None Blood and lymphatic system disorders CTCv4 View
Cardiac disorders - Other None Cardiac disorders CTCv4 View
Sinus tachycardia None Cardiac disorders CTCv4 View
Middle ear inflammation None Ear and labyrinth disorders CTCv4 View
Abdominal pain None Gastrointestinal disorders CTCv4 View
Ascites None Gastrointestinal disorders CTCv4 View
Constipation None Gastrointestinal disorders CTCv4 View
Diarrhea None Gastrointestinal disorders CTCv4 View
Nausea None Gastrointestinal disorders CTCv4 View
Vomiting None Gastrointestinal disorders CTCv4 View
Chills None General disorders CTCv4 View
Edema face None General disorders CTCv4 View
Edema limbs None General disorders CTCv4 View