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 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT00335556
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00335556
Study Brief: Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Surgery Surgery Only None None 2 66 0 66 View
UH-1 Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT None None 19 98 81 98 View
Window/UH-1 Window therapy of vincristine/irinotecan; Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT" None None 3 7 5 7 View
UH-2 Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT None None 0 10 9 10 View
Regimen I Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT None None 3 78 7 78 View
Regimen DD-4A Vincristine/dactinomycin/doxorubicin x25 weeks; XRT" None None 1 30 1 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
43900-Hypoxia None Respiratory, thoracic and mediastinal disorders CTCv4 View
44200-Ileal obstruction None Gastrointestinal disorders CTCv4 View
44800-Infections and infestations - Other specify None Infections and infestations CTCv4 View
51700-Left ventricular systolic dysfunction None Cardiac disorders CTCv4 View
52600-Lipase increased None Investigations CTCv4 View
53100-Lung infection None Infections and infestations CTCv4 View
55700-Multi-organ failure None General disorders CTCv4 View
58000-Neoplasms benign malignant and unspecified (incl cy None Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCv4 View
58100-Nervous system disorders - Other specify None Nervous system disorders CTCv4 View
60600-Pain None General disorders CTCv4 View
65800-Platelet count decreased None Investigations CTCv4 View
65900-Pleural effusion None Respiratory, thoracic and mediastinal disorders CTCv4 View
66000-Pleural hemorrhage None Respiratory, thoracic and mediastinal disorders CTCv4 View
66300-Pneumonitis 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
73700-Sepsis None Infections and infestations CTCv4 View
78300-Sudden death NOS None General disorders CTCv4 View
10300-Abdominal pain None Gastrointestinal disorders CTCv4 View
11100-Acute kidney injury None Renal and urinary disorders CTCv4 View
11300-Adult respiratory distress syndrome None Respiratory, thoracic and mediastinal disorders CTCv4 View
11600-Alanine aminotransferase increased None Investigations CTCv4 View
14900-Ascites None Gastrointestinal disorders CTCv4 View
15000-Aspartate aminotransferase increased None Investigations CTCv4 View
17400-Blood bilirubin increased None Investigations CTCv4 View
19200-Bronchopulmonary hemorrhage None Respiratory, thoracic and mediastinal disorders CTCv4 View
20000-Cardiac arrest None Cardiac disorders CTCv4 View
20100-Cardiac disorders - Other specify None Cardiac disorders CTCv4 View
24100-Creatinine increased None Investigations CTCv4 View
24600-Death NOS None General disorders CTCv4 View
24700-Dehydration None Metabolism and nutrition disorders CTCv4 View
34000-Fibrinogen decreased None Investigations CTCv4 View
37200-General disorders and administration site conditions None General disorders CTCv4 View
39000-Heart failure None Cardiac disorders CTCv4 View
43100-Hypokalemia 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
43600-Hypotension None Vascular disorders CTCv4 View
81200-Treatment related secondary malignancy None Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCv4 View
87900-Vomiting None Gastrointestinal disorders CTCv4 View
88200-Weight gain None Investigations CTCv4 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
59700-Oral pain None Gastrointestinal disorders CTCv4 View
60100-Otitis media None Infections and infestations CTCv4 View
60600-Pain None General disorders CTCv4 View
60700-Pain in extremity None Musculoskeletal and connective tissue disorders CTCv4 View
61800-Pancreatitis None Gastrointestinal disorders CTCv4 View
62500-Pelvic infection None Infections and infestations CTCv4 View
25700-Diarrhea None Gastrointestinal disorders CTCv4 View
43100-Hypokalemia None Metabolism and nutrition disorders CTCv4 View
11600-Alanine aminotransferase increased None Investigations CTCv4 View
13100-Anaphylaxis None Immune system disorders CTCv4 View
13200-Anemia None Blood and lymphatic system disorders CTCv4 View
13500-Anorexia None Metabolism and nutrition disorders CTCv4 View
14100-Apnea None Respiratory, thoracic and mediastinal disorders CTCv4 View
14900-Ascites None Gastrointestinal disorders CTCv4 View
15000-Aspartate aminotransferase increased None Investigations CTCv4 View
15400-Atelectasis None Respiratory, thoracic and mediastinal disorders CTCv4 View
17200-Blood and lymphatic system disorders - Other specif None Blood and lymphatic system disorders CTCv4 View
17400-Blood bilirubin increased None Investigations CTCv4 View
20000-Cardiac arrest None Cardiac disorders CTCv4 View
20500-Catheter related infection None Infections and infestations CTCv4 View
22100-Colitis None Gastrointestinal disorders CTCv4 View
22200-Colonic fistula None Gastrointestinal disorders CTCv4 View
22300-Colonic hemorrhage None Gastrointestinal disorders CTCv4 View
24100-Creatinine increased None Investigations CTCv4 View
24300-Cystitis noninfective None Renal and urinary disorders CTCv4 View
24700-Dehydration None Metabolism and nutrition disorders CTCv4 View
25800-Disseminated intravascular coagulation None Blood and lymphatic system disorders CTCv4 View
27600-Dysphagia None Gastrointestinal disorders CTCv4 View
27800-Dyspnea None Respiratory, thoracic and mediastinal disorders CTCv4 View
28200-Edema face None General disorders CTCv4 View
29400-Enterocolitis None Gastrointestinal disorders CTCv4 View
29500-Enterocolitis infectious None Infections and infestations CTCv4 View
29700-Epistaxis None Respiratory, thoracic and mediastinal disorders CTCv4 View
31200-Esophagitis None Gastrointestinal disorders CTCv4 View
32400-Facial nerve disorder None Nervous system disorders CTCv4 View
33300-Febrile neutropenia None Blood and lymphatic system disorders CTCv4 View
33900-Fever None General disorders CTCv4 View
36400-Gastritis None Gastrointestinal disorders CTCv4 View
36700-Gastrointestinal disorders - Other specify None Gastrointestinal disorders CTCv4 View
37500-GGT increased None Investigations CTCv4 View
38900-Hearing impaired None Ear and labyrinth disorders CTCv4 View
39100-Hematoma None Vascular disorders CTCv4 View
39300-Hematuria None Renal and urinary disorders CTCv4 View
40000-Hepatic failure None Hepatobiliary disorders CTCv4 View
40600-Hepatobiliary disorders - Other specify None Hepatobiliary disorders CTCv4 View
41200-Hydrocephalus None Nervous system 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
41800-Hypernatremia None Metabolism and nutrition disorders CTCv4 View
42100-Hypertension None Vascular 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
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
43600-Hypotension None Vascular disorders CTCv4 View
43900-Hypoxia None Respiratory, thoracic and mediastinal disorders CTCv4 View
44800-Infections and infestations - Other specify None Infections and infestations CTCv4 View
46300-Intra-abdominal hemorrhage None Gastrointestinal disorders CTCv4 View
48400-Investigations - Other specify None Investigations CTCv4 View
51700-Left ventricular systolic dysfunction None Cardiac disorders CTCv4 View
52600-Lipase increased None Investigations CTCv4 View
53100-Lung infection None Infections and infestations CTCv4 View
53500-Lymphedema None Vascular disorders CTCv4 View
53700-Lymphocyte count decreased None Investigations CTCv4 View
53900-Malabsorption None Gastrointestinal disorders CTCv4 View
55600-Mucositis oral None Gastrointestinal disorders CTCv4 View
55700-Multi-organ failure None General disorders CTCv4 View
56900-Myocarditis None Cardiac disorders CTCv4 View
57600-Nausea None Gastrointestinal disorders CTCv4 View
58100-Nervous system disorders - Other specify None Nervous system disorders CTCv4 View
58300-Neutrophil count decreased None Investigations CTCv4 View
59600-Oral hemorrhage None Gastrointestinal disorders CTCv4 View
63100-Pericardial effusion None Cardiac disorders CTCv4 View
63900-Peripheral motor neuropathy None Nervous system disorders CTCv4 View
64100-Peripheral sensory neuropathy None Nervous system disorders CTCv4 View
64200-Peritoneal infection None Infections and infestations CTCv4 View
65200-Pharyngitis None Infections and infestations CTCv4 View
65300-Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders CTCv4 View
65800-Platelet count decreased None Investigations CTCv4 View
65900-Pleural effusion None Respiratory, thoracic and mediastinal disorders CTCv4 View
66300-Pneumonitis None Respiratory, thoracic and mediastinal disorders CTCv4 View
66500-Portal hypertension None Hepatobiliary disorders CTCv4 View
68300-Proteinuria None Renal and urinary 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
69200-Purpura None Skin and subcutaneous tissue disorders CTCv4 View
72700-Right ventricular dysfunction None Cardiac disorders CTCv4 View
73700-Sepsis None Infections and infestations CTCv4 View
73900-Serum amylase increased None Investigations CTCv4 View
74600-Sinusitis None Infections and infestations CTCv4 View
74700-Skin and subcutaneous tissue disorders - Other spec None Skin and subcutaneous tissue disorders CTCv4 View
75200-Skin infection None Infections and infestations CTCv4 View
75700-Small intestinal obstruction None Gastrointestinal disorders CTCv4 View
76000-Small intestine infection None Infections and infestations CTCv4 View
76400-Soft tissue infection None Infections and infestations CTCv4 View
79600-Thromboembolic event None Vascular disorders CTCv4 View
81800-Tumor pain None Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCv4 View
81900-Typhlitis None Gastrointestinal disorders CTCv4 View
82300-Upper respiratory infection None Infections and infestations CTCv4 View
83100-Urinary tract infection None Infections and infestations CTCv4 View
83600-Urine output decreased None Investigations CTCv4 View
86400-Vascular access complication None Injury, poisoning and procedural complications CTCv4 View
87900-Vomiting None Gastrointestinal disorders CTCv4 View
88300-Weight loss None Investigations CTCv4 View
88500-White blood cell decreased None Investigations CTCv4 View
88900-Wound infection None Infections and infestations CTCv4 View
10100-Abdominal distension None Gastrointestinal disorders CTCv4 View
10200-Abdominal infection None Infections and infestations CTCv4 View
10300-Abdominal pain None Gastrointestinal disorders CTCv4 View
10700-Acidosis None Metabolism and nutrition disorders CTCv4 View
11100-Acute kidney injury None Renal and urinary disorders CTCv4 View
11300-Adult respiratory distress syndrome None Respiratory, thoracic and mediastinal disorders CTCv4 View
11400-Agitation None Psychiatric disorders CTCv4 View