Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Hormone refractory prostate cancer
Item
hormone refractory prostate cancer
boolean
C1328504 (UMLS CUI [1])
Disease TNM clinical staging | Secondary malignant neoplasm of bone
Item
stage iv disease with bone metastasis
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2])
Immunotherapy Absent | Hormone Therapy Absent | Therapeutic radiology procedure Absent
Item
no immunotherapy, hormonal therapy or radiotherapy within the previous month
boolean
C0021083 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
ECOG performance status
Item
performance status < or = 2 (ecog)
boolean
C1520224 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine < 1.5 mg/100ml
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Secondary malignant neoplasm of liver | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
serum bilirubin < or = 1.25 x unl (upper normal limit) (or < or = 1.5 x unl in the presence of hepatic metastases); sgot e sgpt < or = 1.5 x unl (or < or = 2.5 x unl in presence of hepatic metastases)
boolean
C1278039 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Left ventricular ejection fraction Cardiac ultrasound | Left ventricular ejection fraction Multiple gated acquisition scanning
Item
left ventricular ejection fraction > or = 50% (measured by cardiac ultrasound or muga scan)
boolean
C0428772 (UMLS CUI [1,1])
C1655737 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Life Expectancy
Item
neutrophils > 1500/mm3; platelets >100000/mm3; hemoglobin >10 g/100 ml· life expectancy of at least 3 months
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0023671 (UMLS CUI [4])
Malignant Neoplasms | Epithelioma Treated Radical
Item
previous malignancies with the exception of radically treated epithelioma
boolean
C0006826 (UMLS CUI [1])
C0553707 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0439807 (UMLS CUI [2,3])
Chemotherapy
Item
previous chemotherapy
boolean
C0392920 (UMLS CUI [1])
Comorbidity | Medical contraindication Investigational New Drugs
Item
comorbidities that would, in the investigator's opinion, contraindicate the use of the drugs in the study
boolean
C0009488 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Diabetic - poor control
Item
uncontrolled diabetes
boolean
C0421258 (UMLS CUI [1])
Cardiac Arrhythmia Severe | Congestive heart failure Uncontrolled Severe | Myocardial Ischemia Severe | Myocardial Infarction
Item
severe cardiac arrhythmias, severe uncontrolled congestive heart failure, severe ischemic cardiac disease or myocardial infarction within the previous 6 months
boolean
C0003811 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0151744 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
Communicable Disease Severe
Item
severe infection
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cerebral metastasis
Item
cerebral metastasis
boolean
C0555278 (UMLS CUI [1])
Neurotoxicity Motor Pre-existing CTCAE Grades | Neurotoxicity Sensory Pre-existing CTCAE Grades
Item
pre-existing motor or sensory neurotoxicity > or = grade 2 according to ctc (common toxicity criteria).
boolean
C0235032 (UMLS CUI [1,1])
C0501384 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C0235032 (UMLS CUI [2,1])
C0501385 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C1516728 (UMLS CUI [2,4])