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 @ 3:03 AM
Ignite Modification Date: 2025-12-26 @ 1:42 AM
NCT ID: NCT00449033
Description: Acronyms used: Absolute Neutrophil Count (ANC), Central Nervous System (CNS), Gastro-Intestinal (GI), Glomerular Filtration Rate (GFR), International Normalized Ratio (INR), Not Otherwise Specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST), Acute respiratory distress syndrome (ARDS), cranial nerve (CN)
Frequency Threshold: 5
Time Frame: None
Study: NCT00449033
Study Brief: A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sorafenib (Nexavar, BAY43-9006) + GC Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met. None None 270 452 440 452 View
Placebo + GC Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met. None None 198 449 435 449 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood - Other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Bone marrow cellularity NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Edema: Head and Neck NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Edema: Limb NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Neutrophils NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Cardiac arrhythmia - Other NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Cardiac general - Other NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Cardiac ischemia/infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Cardiopulmonary arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Conduction abnormality, Conduction abnormality NOS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Left ventricular systolic dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Supraventricular arrhythmia, Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Supraventricular arrhythmia, Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Supraventricular arrhythmia, Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Ventricular arrhythmia, Ventricular arrhythmia NOS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Ventricular arrhythmia, Ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Diabetes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders NCI-CTCAE v.3.0 View
Endocrine - Other NON_SYSTEMATIC_ASSESSMENT Endocrine disorders NCI-CTCAE v.3.0 View
Optic disc edema NON_SYSTEMATIC_ASSESSMENT Eye disorders NCI-CTCAE v.3.0 View
Vitreous hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders NCI-CTCAE v.3.0 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
GI - Other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Mucositis (functional/symptomatic), Esophagus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Mucositis (functional/symptomatic), Oral cavity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Obstruction, GI, Colon NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Obstruction, GI, Gallbladder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Obstruction, GI, Ileum NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Perforation, GI, Colon NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Perforation, GI, Stomach NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Stricture, GI, Colon NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Stricture, GI, Esophagus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Constitutional symptoms - Other NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Death not associated with CTCAE term, Death NOS NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Death not associated with CTCAE term, Disease progression NOS NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Death not associated with CTCAE term, Multi-Organ Failure NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Death not associated with CTCAE term, Sudden death NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Hypothermia NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
No code in CTCAE NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Abdomen NOS NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Back NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Chest wall NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Chest/Thorax NOS NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Extremity - limb NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Gallbladder NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Head/Headache NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Neuralgia/Peripheral nerve NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Other NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Pelvis NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Stomach NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Tumor lysis syndrome NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Weight loss NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Hepatobiliary - Other NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI-CTCAE v.3.0 View
Infection - Other NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with normal ANC, Abdomen NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with normal ANC, Anal/perianal NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with unknown ANC, Wound NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Intraop injury, Jejunum NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI-CTCAE v.3.0 View
Intraop injury, Lung NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI-CTCAE v.3.0 View
Muscle weakness, Extremity - lower NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI-CTCAE v.3.0 View
Speech impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Syncope (Fainting) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Pulmonary - Other NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Dermatology - Other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE v.3.0 View
Erythema multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE v.3.0 View
Hemorrhage, GI, Rectum NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Hemorrhage, GI, Stomach NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Hemorrhage, GI, Upper GI NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
INR NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Pain, Bone NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Tumor pain NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Liver dysfunction NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI-CTCAE v.3.0 View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI-CTCAE v.3.0 View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders NCI-CTCAE v.3.0 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection (Documented clinically), Bladder (urinary) NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection (Documented clinically), Blood NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection (Documented clinically), Bronchus NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection (Documented clinically), Kidney NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection (Documented clinically), Lung (Pneumonia) NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection (Documented clinically), Pleura (Empyema) NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection (Documented clinically), Upper airway NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with normal ANC, Blood NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with normal ANC, Bronchus NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with normal ANC, Catheter-related NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with normal ANC, Lung (Pneumonia) NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with normal ANC, Meninges (Meningitis) NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with normal ANC, Scrotum NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with normal ANC, Skin (cellulitis) NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with normal ANC, Soft tissue NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with normal ANC, Urinary tract NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with unknown ANC, Blood NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with unknown ANC, Lung (Pneumonia) NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with unknown ANC, Pleura (Empyema) NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
Infection with unknown ANC, Soft tissue NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
ALT NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Bilirubin (Hyperbilirubinemia) NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Creatinine NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
GFR NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI-CTCAE v.3.0 View
Muscle weakness, Whole body/generalized NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI-CTCAE v.3.0 View
Musculoskeletal - Other NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI-CTCAE v.3.0 View
Osteoporosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI-CTCAE v.3.0 View
Soft tissue necrosis, Extremity - lower NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI-CTCAE v.3.0 View
CNS ischemia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Confusion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Mood alteration, Depression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Neurology - Other NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Neuropathy: Cranial, CN II Vision NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Neuropathy: motor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Neuropathy: sensory NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Personality NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Pyramidal tract dysfunction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Renal - Other NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI-CTCAE v.3.0 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI-CTCAE v.3.0 View
ARDS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Airway obstruction, Bronchus NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Dyspnea (Shortness of breath) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Hand-foot skin reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE v.3.0 View
Rash/desquamation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE v.3.0 View
Artery injury, Aorta NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
CNS hemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Hemorrhage - Other NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Hemorrhage pulmonary, Bronchopulmonary NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Hemorrhage pulmonary, Lung NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Hemorrhage pulmonary, Nose NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Hemorrhage pulmonary, Respiratory tract NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Hemorrhage, GI, Abdomen NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Hemorrhage, GI, Anus NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Hemorrhage, GI, Colon NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Hemorrhage, GI, Duodenum NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Peripheral arterial ischemia NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Phlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Thrombosis/Embolism (vascular access) NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Thrombosis/Thrombus/Embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Vascular - Other NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Visceral arterial ischemia NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutrophils NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE v.3.0 View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders NCI-CTCAE v.3.0 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Mucositis (functional/symptomatic), Oral cavity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Taste Alteration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE v.3.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Abdomen NOS NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Back NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Extremity - limb NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Head/Headache NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Joint NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Muscle NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Stomach NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Pain, Throat/Pharynx/Larynx NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Weight loss NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View
Infection with normal ANC, Upper airway NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE v.3.0 View
ALT NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
AST NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Creatinine NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Metabolic/Lab - Other NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE v.3.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Neuropathy: sensory NON_SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE v.3.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Dyspnea (Shortness of breath) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Voice changes NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE v.3.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE v.3.0 View
Dermatology - Other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE v.3.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE v.3.0 View
Hand-foot skin reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE v.3.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE v.3.0 View
Rash/desquamation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE v.3.0 View
Hemorrhage pulmonary, Nose NON_SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE v.3.0 View
Blood - Other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Edema: Limb NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Leukocytes NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE v.3.0 View
Pain, Chest/Thorax NOS NON_SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE v.3.0 View