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 @ 2:08 AM
Ignite Modification Date: 2025-12-26 @ 12:34 AM
NCT ID: NCT00980460
Description: Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Frequency Threshold: 0
Time Frame: AEs and OAEs: Up to 6 months post-treatment planned as 18 months; All-Cause Mortality: up to 10 years
Study: NCT00980460
Study Brief: Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intermediate-risk Group (Regimen F) Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012) Cisplatin: Given IV Dexrazoxane: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV 7 None 3 102 91 102 View
High-risk Group (Regimen W) (regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV 11 None 2 31 27 31 View
High-risk Group (Regimen H) Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. Cisplatin: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Temsirolimus: Given IV Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV 13 None 1 36 32 36 View
Very Low-risk Group Patients undergo surgery and then receive no further treatment. Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery 0 None 0 8 0 8 View
Low-risk Group (Regimen T) Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Cisplatin: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV 3 None 0 49 24 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Esophageal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Left ventricular systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Portal hypertension SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Postoperative hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Surgical and medical procedures - Other, specify SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abducens nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anaphylaxis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Biliary anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Biliary fistula SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colonic hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
CPK increased SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Duodenal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Duodenal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations None View
Gastric fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
GGT increased SYSTEMATIC_ASSESSMENT Investigations None View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hepatic hemorrhage SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatobiliary disorders - Other, specify SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None 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
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Immune system disorders - Other, specify SYSTEMATIC_ASSESSMENT Immune system disorders None View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders None View
INR increased SYSTEMATIC_ASSESSMENT Investigations None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Intraoperative hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations None View
Irritability SYSTEMATIC_ASSESSMENT General disorders None View
Left ventricular systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Malabsorption SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Metabolism and nutrition disorders - Other, specify SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oculomotor nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Periorbital infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peritoneal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Postoperative hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal calculi SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Serum amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Small intestinal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small intestine infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tumor lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vascular disorders - Other, specify SYSTEMATIC_ASSESSMENT Vascular disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View