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 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:10 PM
NCT ID: NCT00072358
Description: None
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT00072358
Study Brief: Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With 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
Participants With Refractory Bone Marrow Disease and High Risk of Recurrence Participants included have refractory bone marrow disease and high risk of recurrence of refractory bone marrow disease. All participants will receive anti-GD2 murine IgG3 monoclonal antibody 3F8. As per the study team, the data were not collected in the manner requested. As a result they cannot separate the patients into the respective protocol groups. 135 None 153 291 287 291 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular 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
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection unk ANC SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection w.out neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection with grade 3/4 neut SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection/Feb Neut-Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Irritability < 3 years SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Leukocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Middle ear/hearing SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Mood alteration-anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neurology, other SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutrophils/gran SYSTEMATIC_ASSESSMENT Investigations None View
Pain, other SYSTEMATIC_ASSESSMENT General disorders None View
Platelets SYSTEMATIC_ASSESSMENT Investigations None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pulmonary, other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash, desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rigors, chills SYSTEMATIC_ASSESSMENT General disorders None View
SGPT (ALT) SYSTEMATIC_ASSESSMENT Investigations None View
Secondary malignancy, other SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
GI, other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Blood,Bone marrow,other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiovascular, Arrhythmia other SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ARDS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Allergic Reaction/Hyper SYSTEMATIC_ASSESSMENT Immune system disorders None View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
CNS hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cardiac left vent SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiovascular, other SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Catheter-rel inf SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Depressed level of cons SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia, esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash, desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea (Pts w/out col) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Pulmonary, other SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pain, other SYSTEMATIC_ASSESSMENT General disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Mood alteration-anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abdominal pain/cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Allergy, other SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Irritability < 3 years SYSTEMATIC_ASSESSMENT Psychiatric disorders None View