{"eventGroups":[{"description":"Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.","id":"EG000","otherNumAffected":49,"otherNumAtRisk":51,"seriousNumAffected":31,"seriousNumAtRisk":51,"title":"Treatment (Enzyme Inhibitor Therapy)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pain in the abdominal region.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":51}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Increased levels of alanine aminotransferase, indicative of liver damage or disease.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":51}],"term":"Alanine aminotransferase (ALT) increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Increased levels of Alkaline phosphatase","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":51}],"term":"Alkaline phosphatase (ALP) increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Allergic rhinitis is an allergic inflammation of the nasal airways.","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Allergic rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Anemia is a decrease in number of red blood cells (RBCs) or less than the normal quantity of hemoglobin in the blood.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":51}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Anorexia is the decreased sensation of appetite.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":51}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Anxiety is an unpleasant state of inner turmoil and apprehension, often accompanied by nervous behavior, such as pacing back and forth, somatic complaints and rumination.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":51}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Joint pain.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Increased levels of aspartate aminotransferase (AST)","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":51}],"term":"Aspartate aminotransferase (AST) increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pain in the back.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":51}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pain in chest wall","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":51}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Constipation (also known as costiveness or dyschezia) refers to bowel movements that are infrequent or hard to pass.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":51}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A cough is a sudden and often repetitively occurring reflex which helps to clear the large breathing passages from secretions, irritants, foreign particles and microbes.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":51}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Increased levels of creatinine","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Dehydration is the excessive loss of body water","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Depression is a mental disorder characterized by episodes of all-encompassing low mood accompanied by low self-esteem and loss of interest or pleasure in normally enjoyable activities.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Diarrhea is the condition of having three or more loose or liquid bowel movements per day.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":51}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Dry mouth is associated a change in the composition of saliva or reduced salivary flow (hyposalivation).","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Dysgeusia is a distortion of the sense of taste","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":51}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Dyspepsia is a condition of impaired digestion characterized by chronic or recurrent pain in the upper abdomen, upper abdominal fullness and feeling full earlier than expected when eating.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":51}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Dysphagia is the medical term for the symptom of difficulty in swallowing.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Dyspnea - shortness of breath.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":51}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Swelling of tissues in the limbs due to the accumulation of fluids.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":51}],"term":"Edema (limb)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Nosebleed","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Fatigue (also called exhaustion, tiredness, lethargy, languidness, languor, lassitude, and listlessness) is a subjective feeling of tiredness which is distinct from weakness, and has a gradual onset.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":51}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pain in the head or neck region.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":51}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hematuria is blood in the urine.","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hyperglycemia, or high blood sugar is a condition in which an excessive amount of glucose circulates in the blood plasma.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":51}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":51}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Elevated blood pressure in the arteries.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":51}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hypoalbuminemia is a medical condition where levels of albumin in blood serum are abnormally low.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":51}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hypocalcemia is the presence of low serum calcium levels in the blood, usually taken as less than 2.1 mmol/L or 9 mg/dl or an ionized calcium level of less than 1.1 mmol/L or 4.5 mg/dL.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hypoglycemia is an abnormally diminished content of glucose in the blood.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hypomagnesemia (or hypomagnesaemia) is an electrolyte disturbance in which there is an abnormally low level of magnesium in the blood.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":51}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hyponatremia - An electrolyte disturbance in which the sodium ion concentration in the serum is lower than normal.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":51}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hypotension is low blood pressure.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hypothyroidism is a state in which the thyroid gland does not produce a sufficient amount of the thyroid hormones thyroxine (T4) and triiodothyronine (T3).","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":51}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Insomnia, or sleeplessness, is a sleep disorder in which there is an inability to fall asleep or to stay asleep as long as desired.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":51}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Low lymphocyte count","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":51}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Inflammation and ulceration that occurs in the mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":51}],"term":"Mucositis (oral)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Muscle weakness is a lack of muscle strength.","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Fingernail loss is a removal of the whole or part of the nail from the bed.","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Nail loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Nausea a sensation of unease and discomfort in the upper stomach with an involuntary urge to vomit.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":51}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pain in the mouth.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pain in unspecified region.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51}],"term":"Pain - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pain in extremity","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Palmar-plantar erythrodysesthesia (hand-foot) syndrome results when a small amount of drug leaks out of the blood vessels, damaging tissues.","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":51}],"term":"Palmar-plantar erythrodysesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Inflammation or degeneration of the sensory nerves.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by marked discomfort sensation in the pharyngolaryngeal (pharynx/larynx) region.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":51}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Low platelet count","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":51}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Proteinuria-also called albuminuria or urine albumin-is a condition in which urine contains an abnormal amount of protein.","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":51}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A maculopapular rash is a type of rash characterized by a flat, red area on the skin that is covered with small confluent bumps.","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":51}],"term":"Rash (maculo-papular)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Sinus tachycardia is a heart rhythm with elevated rate of impulses originating from the sinoatrial node, defined as a rate greater than 100 beats/min (bpm) in an average adult.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hoarseness, loss or alteration in voice, laryngitis","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":51}],"term":"Voice changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Vomiting is the forceful expulsion of the contents of one's stomach through the mouth and sometimes the nose.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":51}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Weight loss is a reduction of the total body mass, due to a mean loss of fluid, body fat or adipose tissue and/or lean mass, namely bone mineral deposits, muscle, tendon and other connective tissue.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":51}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Low white blood cell count","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"White blood cell count decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Abdominal distension occurs when substances, such as air (gas) or fluid, accumulate in the abdomen causing its outward expansion beyond the normal girth of the stomach and waist.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pain in the abdominal region","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Increased levels of alanine aminotransferase, indicative of liver damage or disease.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Anaphylaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Anorexia is the decreased sensation of appetite.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Increased levels of aspartate aminotransferase (AST)","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Atelectasis is defined as the collapse or closure of the lung resulting in reduced or absent gas exchange.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Atrial flutter (AFL) is an abnormal heart rhythm that occurs in the atria of the heart.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Bronchopulmonary hemorrhage is a disorder characterized by bleeding from the bronchial wall and/or lung parenchyma.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Bronchopulmonary hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Cardiac arrest, also known as cardiopulmonary arrest or circulatory arrest, is the cessation of normal circulation of the blood due to failure of the heart to contract effectively.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pain in the chest wall not attributed to any cardiac disorder.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":51}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by a conspicuous change in cognitive function.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Cognitive disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Impairment of conduction in heart excitation; often applied specifically to atrioventricular heart block.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Conduction disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Loss of orientation (ability to place oneself correctly in the world by time, location, and/or personal identity sometimes accompanied by disordered consciousness and often memory (ability to correctly recall previous events or learn new material).","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Constipation (also known as costiveness or dyschezia) refers to bowel movements that are infrequent or hard to pass.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Increased levels of creatinine","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Dehydration is the excessive loss of body water","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A neurologic state characterized by decreased ability to perceive and respond.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Condition of having three or more loose or liquid bowel movements per day","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Dizziness is an impairment in spatial perception and stability.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Dyspnea - shortness of breath.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":51}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Electrocardiogram QT corrected interval prolonged","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"ECG QTc interval prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Syndrome of global brain dysfunction","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Insufficient weight gain or inappropriate weight loss.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Fatigue (also called exhaustion, tiredness, lethargy, languidness, languor, lassitude, and listlessness) is a subjective feeling of tiredness which is distinct from weakness, and has a gradual onset.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pain in the head or neck region.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hyperglycemia, or high blood sugar is a condition in which an excessive amount of glucose circulates in the blood plasma.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Elevated blood pressure in the arteries","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hypoalbuminemia is a medical condition where levels of albumin in blood serum are abnormally low.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hypoglycemia is an abnormally diminished content of glucose in the blood.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hyponatremia - An electrolyte disturbance in which the sodium ion concentration in the serum is lower than normal.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hypotension is low blood pressure.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Blood infection with unknown Absolute Neutrophil Count (ANC)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Infection with unknown ANC: Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"An intracranial hemorrhage (ICH) is a hemorrhage, or bleeding, within the skull.","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Infection in the lung","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Lymphocyte count decreased","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Second-degree atrioventricular (AV) block is a disease of the electrical conduction system of the heart. It refers to a conduction block between the atria and ventricles.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Mobitz (type) II atrioventricular block"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Muscle weakness or myasthenia is a lack of muscle strength.","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pericardial effusion (\"fluid around the heart\") is an abnormal accumulation of fluid in the pericardial cavity.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A disorder characterized by inflammation or degeneration of the peripheral motor nerves.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pleural effusion is excess fluid that accumulates between the two pleural layers, the fluid-filled space that surrounds the lungs.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A pneumothorax is an abnormal collection of air or gas in the pleural space that separates the lung from the chest wall and which may interfere with normal breathing.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Proteinuria-also called albuminuria or urine albumin-is a condition in which urine contains an abnormal amount of protein","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pulmonary embolism (PE) is a blockage of the main artery of the lung or one of its branches by a substance that has traveled from elsewhere in the body through the bloodstream (embolism).","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A seizure is the physical findings or changes in behavior that occur after an episode of abnormal electrical activity in the brain.","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Sepsis is a potentially deadly medical condition characterized by a whole-body inflammatory state (called a systemic inflammatory response syndrome or SIRS) caused by severe infection.","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Sinus tachycardia is a heart rhythm with elevated rate of impulses originating from the sinoatrial node, defined as a rate greater than 100 beats/min (bpm) in an average adult.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Intestinal obstruction is a blockage that keeps food or liquid from passing through the small intestine.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Formation of a blood clot inside a blood vessel, obstructing the flow of blood through the circulatory system.","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":51}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Urinary retention is the inability to empty the bladder.","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51}],"term":"Urinary retention"}],"timeFrame":"After completion of study treatment, patients are followed for up to 8 weeks."}