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 @ 9:20 PM
Ignite Modification Date: 2025-12-25 @ 7:07 PM
NCT ID: NCT01798004
Description: None
Frequency Threshold: 0
Time Frame: Four ineligible patients were excluded from the Adverse Event tables, so even though 150 patients enrolled on the study and are summarized in the Participant Flow template, only 146 were at risk for adverse events.
Study: NCT01798004
Study Brief: Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk 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
All Patients Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT None None 10 146 82 146 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ascites None Gastrointestinal disorders CTCAE4 View
Death NOS None General disorders CTCAE4 View
Multi-organ failure None General disorders CTCAE4 View
Hepatobiliary disorders - Other, specify None Hepatobiliary disorders CTCAE4 View
Lung infection None Infections and infestations CTCAE4 View
Sepsis None Infections and infestations CTCAE4 View
Upper respiratory infection None Infections and infestations CTCAE4 View
Aspartate aminotransferase increased None Investigations CTCAE4 View
Blood bilirubin increased None Investigations CTCAE4 View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify None Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE4 View
Atelectasis None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Bronchopulmonary hemorrhage None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Dyspnea None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Hypoxia None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Pleural effusion None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Pulmonary edema None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Respiratory failure None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vasovagal reaction None Nervous system disorders CTCAE4 View
Anxiety None Psychiatric disorders CTCAE4 View
Acute kidney injury None Renal and urinary disorders CTCAE4 View
Adult respiratory distress syndrome None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Apnea None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Dyspnea None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Epistaxis None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Hypoxia None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Pleural effusion None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Pneumothorax None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Pulmonary edema None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Infections and infestations - Other, specify None Infections and infestations CTCAE4 View
Lung infection None Infections and infestations CTCAE4 View
Peritoneal infection None Infections and infestations CTCAE4 View
Sepsis None Infections and infestations CTCAE4 View
Anemia None Blood and lymphatic system disorders CTCAE4 View
Febrile neutropenia None Blood and lymphatic system disorders CTCAE4 View
Asystole None Cardiac disorders CTCAE4 View
Cardiac arrest None Cardiac disorders CTCAE4 View
Sinus bradycardia None Cardiac disorders CTCAE4 View
Sinus tachycardia None Cardiac disorders CTCAE4 View
Hearing impaired None Ear and labyrinth disorders CTCAE4 View
Abdominal distension None Gastrointestinal disorders CTCAE4 View
Abdominal pain None Gastrointestinal disorders CTCAE4 View
Anal pain None Gastrointestinal disorders CTCAE4 View
Ascites None Gastrointestinal disorders CTCAE4 View
Colitis None Gastrointestinal disorders CTCAE4 View
Diarrhea None Gastrointestinal disorders CTCAE4 View
Enterocolitis None Gastrointestinal disorders CTCAE4 View
Gastrointestinal disorders - Other, specify None Gastrointestinal disorders CTCAE4 View
Lower gastrointestinal hemorrhage None Gastrointestinal disorders CTCAE4 View
Mucositis oral None Gastrointestinal disorders CTCAE4 View
Nausea None Gastrointestinal disorders CTCAE4 View
Vomiting None Gastrointestinal disorders CTCAE4 View
Fever None General disorders CTCAE4 View
Multi-organ failure None General disorders CTCAE4 View
Pain None General disorders CTCAE4 View
Hepatic pain None Hepatobiliary disorders CTCAE4 View
Hepatobiliary disorders - Other, specify None Hepatobiliary disorders CTCAE4 View
Portal hypertension None Hepatobiliary disorders CTCAE4 View
Anaphylaxis None Immune system disorders CTCAE4 View
Autoimmune disorder None Immune system disorders CTCAE4 View
Catheter related infection None Infections and infestations CTCAE4 View
Tracheitis None Infections and infestations CTCAE4 View
Intraoperative arterial injury None Injury, poisoning and procedural complications CTCAE4 View
Intraoperative hemorrhage None Injury, poisoning and procedural complications CTCAE4 View
Intraoperative venous injury None Injury, poisoning and procedural complications CTCAE4 View
Alanine aminotransferase increased None Investigations CTCAE4 View
Aspartate aminotransferase increased None Investigations CTCAE4 View
Blood bilirubin increased None Investigations CTCAE4 View
Electrocardiogram QT corrected interval prolonged None Investigations CTCAE4 View
GGT increased None Investigations CTCAE4 View
Investigations - Other, specify None Investigations CTCAE4 View
Neutrophil count decreased None Investigations CTCAE4 View
Platelet count decreased None Investigations CTCAE4 View
Weight gain None Investigations CTCAE4 View
White blood cell decreased None Investigations CTCAE4 View
Acidosis None Metabolism and nutrition disorders CTCAE4 View
Anorexia None Metabolism and nutrition disorders CTCAE4 View
Dehydration None Metabolism and nutrition disorders CTCAE4 View
Hyperglycemia None Metabolism and nutrition disorders CTCAE4 View
Hyperkalemia None Metabolism and nutrition disorders CTCAE4 View
Hypertriglyceridemia None Metabolism and nutrition disorders CTCAE4 View
Hypoalbuminemia None Metabolism and nutrition disorders CTCAE4 View
Hypocalcemia None Metabolism and nutrition disorders CTCAE4 View
Hypoglycemia None Metabolism and nutrition disorders CTCAE4 View
Hypokalemia None Metabolism and nutrition disorders CTCAE4 View
Hyponatremia None Metabolism and nutrition disorders CTCAE4 View
Hypophosphatemia None Metabolism and nutrition disorders CTCAE4 View
Seizure None Nervous system disorders CTCAE4 View
Respiratory failure None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Respiratory, thoracic and mediastinal disorders - Other, specify None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Sore throat None Respiratory, thoracic and mediastinal disorders CTCAE4 View
Capillary leak syndrome None Vascular disorders CTCAE4 View
Hypertension None Vascular disorders CTCAE4 View
Hypotension None Vascular disorders CTCAE4 View
Thromboembolic event None Vascular disorders CTCAE4 View
Vascular disorders - Other, specify None Vascular disorders CTCAE4 View