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 @ 2:18 AM
Ignite Modification Date: 2025-12-26 @ 12:48 AM
NCT ID: NCT01857934
Description: CTCAE v4.0 Grades 3 and 4 toxicities
Frequency Threshold: 5
Time Frame: Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment.
Study: NCT01857934
Study Brief: Therapy for Children With Advanced Stage 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
NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) All newly diagnosed, high-risk neuroblastoma participants \<19 years of age who had histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines, with adequate renal and hepatic function, no prior therapy and consent to the study. 1 None 40 64 64 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Asystole NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intra-abdominal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Typhlitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hepatic failure NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Catheter related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Duodenal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterocolitis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infections and infestations - Other, specify NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
GGT increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperuricemia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Metabolism and nutrition disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Depressed level of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cystitis noninfective NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Apnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary hypertension NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thromboembolic event NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hepatobiliary disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hearing impaired NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hepatobiliary disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Enterocolitis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Catheter related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Device related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infections and infestations - Other, specify NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bladder infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
GGT increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood antidiuretic hormone abnormal NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alkalosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperuricemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cystitis noninfective NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View