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 @ 11:35 PM
Ignite Modification Date: 2025-12-25 @ 9:24 PM
NCT ID: NCT01175356
Description: The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
Frequency Threshold: 0
Time Frame: None
Study: NCT01175356
Study Brief: Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (131I-MIBG, Chemotherapy) Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT. None None 27 98 86 98 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
74500-Sinus tachycardia None Cardiac disorders CTCv4 View
14900-Ascites None Gastrointestinal disorders CTCv4 View
55600-Mucositis oral None Gastrointestinal disorders CTCv4 View
24600-Death NOS None General disorders CTCv4 View
37200-General disorders and administration site conditions - Other specify None General disorders CTCv4 View
55700-Multi-organ failure None General disorders CTCv4 View
60600-Pain None General disorders CTCv4 View
21600-Cholecystitis None Hepatobiliary disorders CTCv4 View
40000-Hepatic failure None Hepatobiliary disorders CTCv4 View
40600-Hepatobiliary disorders - Other specify None Hepatobiliary disorders CTCv4 View
66500-Portal hypertension None Hepatobiliary disorders CTCv4 View
53100-Lung infection None Infections and infestations CTCv4 View
73700-Sepsis None Infections and infestations CTCv4 View
11600-Alanine aminotransferase increased None Investigations CTCv4 View
15000-Aspartate aminotransferase increased None Investigations CTCv4 View
17400-Blood bilirubin increased None Investigations CTCv4 View
45800-INR increased None Investigations CTCv4 View
88200-Weight gain None Investigations CTCv4 View
88300-Weight loss None Investigations CTCv4 View
10700-Acidosis None Metabolism and nutrition disorders CTCv4 View
13500-Anorexia None Metabolism and nutrition disorders CTCv4 View
41600-Hyperkalemia None Metabolism and nutrition disorders CTCv4 View
41800-Hypernatremia None Metabolism and nutrition disorders CTCv4 View
42600-Hypoalbuminemia None Metabolism and nutrition disorders CTCv4 View
43300-Hyponatremia None Metabolism and nutrition disorders CTCv4 View
72500-Reversible posterior leukoencephalopathy syndrome None Nervous system disorders CTCv4 View
43900-Hypoxia None Respiratory, thoracic and mediastinal disorders CTCv4 View
71600-Respiratory thoracic and mediastinal disorders - Other specify None Respiratory, thoracic and mediastinal disorders CTCv4 View
43600-Hypotension None Vascular disorders CTCv4 View
39000-Heart failure None Cardiac disorders CTCv4 View
10300-Abdominal pain None Gastrointestinal disorders CTCv4 View
40400-Hepatic pain None Hepatobiliary disorders CTCv4 View
44800-Infections and infestations - Other specify None Infections and infestations CTCv4 View
10900-Activated partial thromboplastin time prolonged None Investigations CTCv4 View
43100-Hypokalemia None Metabolism and nutrition disorders CTCv4 View
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify None Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCv4 View
65900-Pleural effusion None Respiratory, thoracic and mediastinal disorders CTCv4 View
69000-Pulmonary hypertension None Respiratory, thoracic and mediastinal disorders CTCv4 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
13200-Anemia None Blood and lymphatic system disorders CTCv4 View
33300-Febrile neutropenia None Blood and lymphatic system disorders CTCv4 View
20000-Cardiac arrest None Cardiac disorders CTCv4 View
78900-Supraventricular tachycardia None Cardiac disorders CTCv4 View
38900-Hearing impaired None Ear and labyrinth disorders CTCv4 View
10100-Abdominal distension None Gastrointestinal disorders CTCv4 View
10300-Abdominal pain None Gastrointestinal disorders CTCv4 View
14900-Ascites None Gastrointestinal disorders CTCv4 View
22100-Colitis None Gastrointestinal disorders CTCv4 View
25700-Diarrhea None Gastrointestinal disorders CTCv4 View
29400-Enterocolitis None Gastrointestinal disorders CTCv4 View
36400-Gastritis None Gastrointestinal disorders CTCv4 View
44600-Ileus None Gastrointestinal disorders CTCv4 View
55600-Mucositis oral None Gastrointestinal disorders CTCv4 View
57600-Nausea None Gastrointestinal disorders CTCv4 View
59700-Oral pain None Gastrointestinal disorders CTCv4 View
81900-Typhlitis None Gastrointestinal disorders CTCv4 View
87900-Vomiting None Gastrointestinal disorders CTCv4 View
33900-Fever None General disorders CTCv4 View
37200-General disorders and administration site conditions - Other specify None General disorders CTCv4 View
60600-Pain None General disorders CTCv4 View
12000-Allergic reaction None Immune system disorders CTCv4 View
13100-Anaphylaxis None Immune system disorders CTCv4 View
20500-Catheter related infection None Infections and infestations CTCv4 View
25600-Device related infection None Infections and infestations CTCv4 View
44800-Infections and infestations - Other specify None Infections and infestations CTCv4 View
53100-Lung infection None Infections and infestations CTCv4 View
61100-Pancreas infection None Infections and infestations CTCv4 View
73700-Sepsis None Infections and infestations CTCv4 View
74600-Sinusitis None Infections and infestations CTCv4 View
75200-Skin infection None Infections and infestations CTCv4 View
76000-Small intestine infection None Infections and infestations CTCv4 View
82300-Upper respiratory infection None Infections and infestations CTCv4 View
83100-Urinary tract infection None Infections and infestations CTCv4 View
88900-Wound infection None Infections and infestations CTCv4 View
13800-Aortic injury None Injury, poisoning and procedural complications CTCv4 View
45700-Injury poisoning and procedural complications - Other specify None Injury, poisoning and procedural complications CTCv4 View
47300-Intraoperative hepatobiliary injury None Injury, poisoning and procedural complications CTCv4 View
47700-Intraoperative renal injury None Injury, poisoning and procedural complications CTCv4 View
10900-Activated partial thromboplastin time prolonged None Investigations CTCv4 View
11600-Alanine aminotransferase increased None Investigations CTCv4 View
15000-Aspartate aminotransferase increased None Investigations CTCv4 View
17400-Blood bilirubin increased None Investigations CTCv4 View
24100-Creatinine increased None Investigations CTCv4 View
34000-Fibrinogen decreased None Investigations CTCv4 View
37500-GGT increased None Investigations CTCv4 View
52600-Lipase increased None Investigations CTCv4 View
53700-Lymphocyte count decreased None Investigations CTCv4 View
58300-Neutrophil count decreased None Investigations CTCv4 View
65800-Platelet count decreased None Investigations CTCv4 View
88200-Weight gain None Investigations CTCv4 View
88300-Weight loss None Investigations CTCv4 View
88500-White blood cell decreased None Investigations CTCv4 View
10700-Acidosis None Metabolism and nutrition disorders CTCv4 View
13500-Anorexia None Metabolism and nutrition disorders CTCv4 View
24700-Dehydration None Metabolism and nutrition disorders CTCv4 View
41300-Hypercalcemia None Metabolism and nutrition disorders CTCv4 View
41400-Hyperglycemia None Metabolism and nutrition disorders CTCv4 View
41600-Hyperkalemia None Metabolism and nutrition disorders CTCv4 View
41700-Hypermagnesemia None Metabolism and nutrition disorders CTCv4 View
41800-Hypernatremia None Metabolism and nutrition disorders CTCv4 View
42600-Hypoalbuminemia None Metabolism and nutrition disorders CTCv4 View
42700-Hypocalcemia None Metabolism and nutrition disorders CTCv4 View
42900-Hypoglycemia None Metabolism and nutrition disorders CTCv4 View
43100-Hypokalemia None Metabolism and nutrition disorders CTCv4 View
43200-Hypomagnesemia None Metabolism and nutrition disorders CTCv4 View
43300-Hyponatremia None Metabolism and nutrition disorders CTCv4 View
43500-Hypophosphatemia None Metabolism and nutrition disorders CTCv4 View
54900-Metabolism and nutrition disorders - Other specify None Metabolism and nutrition disorders CTCv4 View
18200-Bone pain None Musculoskeletal and connective tissue disorders CTCv4 View
37300-Generalized muscle weakness None Musculoskeletal and connective tissue disorders CTCv4 View
60700-Pain in extremity None Musculoskeletal and connective tissue disorders CTCv4 View
10500-Abducens nerve disorder None Nervous system disorders CTCv4 View
38800-Headache None Nervous system disorders CTCv4 View
79100-Syncope None Nervous system disorders CTCv4 View
11400-Agitation None Psychiatric disorders CTCv4 View
13700-Anxiety None Psychiatric disorders CTCv4 View
25400-Depression None Psychiatric disorders CTCv4 View
11100-Acute kidney injury None Renal and urinary disorders CTCv4 View
39300-Hematuria None Renal and urinary disorders CTCv4 View
71100-Renal calculi None Renal and urinary disorders CTCv4 View
19300-Bronchospasm None Respiratory, thoracic and mediastinal disorders CTCv4 View
29700-Epistaxis None Respiratory, thoracic and mediastinal disorders CTCv4 View
43900-Hypoxia None Respiratory, thoracic and mediastinal disorders CTCv4 View
64900-Pharyngeal mucositis None Respiratory, thoracic and mediastinal disorders CTCv4 View
66400-Pneumothorax None Respiratory, thoracic and mediastinal disorders CTCv4 View
68700-Pulmonary edema None Respiratory, thoracic and mediastinal disorders CTCv4 View
69000-Pulmonary hypertension None Respiratory, thoracic and mediastinal disorders CTCv4 View
71500-Respiratory failure None Respiratory, thoracic and mediastinal disorders CTCv4 View
78100-Stridor None Respiratory, thoracic and mediastinal disorders CTCv4 View
74700-Skin and subcutaneous tissue disorders - Other specify None Skin and subcutaneous tissue disorders CTCv4 View
79000-Surgical and medical procedures - Other specify None Surgical and medical procedures CTCv4 View
39100-Hematoma None Vascular disorders CTCv4 View
42100-Hypertension None Vascular disorders CTCv4 View
43600-Hypotension None Vascular disorders CTCv4 View