hypercalcemia of malignancy
Item
hypercalcemia of malignancy (hcm) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (csc) > 12.5 mg/dl (3.1 millimoles /l) at screening by local laboratory
boolean
C0020437 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Diphosphonates, intravenous administration, Before Screening procedure; Corrected serum calcium measurement
Item
last iv bisphosphonate treatment must be >/= to 7 days and </= to 30 days before the screening corrected serum calcium
boolean
C0012544 (UMLS CUI [1,1])
C0013125 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
C0455288 (UMLS CUI [2])
Age
Item
adults (>/=18 years)
boolean
C0001779 (UMLS CUI [1])
body system or organ function
Item
adequate organ function as defined by the following criteria:
boolean
C0678852 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
serum aspartate aminotransferase (ast) </= 5 x upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
serum alanine aminotransferase (alt) </= 5 x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum total bilirubin </= 2 x upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Hyperparathyroidism, Benign; Hyperthyroidism; Adrenal gland hypofunction; Poisoning by vitamin D; Milk-Alkali Syndrome; Sarcoidosis; Granulomatous disorder, Other
Item
evidence of benign hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin d intoxication, milk alkali syndrome, sarcoidosis, or other granulomatous disease
boolean
C0020502 (UMLS CUI [1,1])
C0205183 (UMLS CUI [1,2])
C0020550 (UMLS CUI [2])
C0001623 (UMLS CUI [3])
C0242154 (UMLS CUI [4])
C0026141 (UMLS CUI [5])
C0036202 (UMLS CUI [6])
C0740451 (UMLS CUI [7,1])
C0205394 (UMLS CUI [7,2])
Kidney Failure, Dialysis procedure
Item
receiving dialysis for renal failure
boolean
C0035078 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
Thiazide Diuretics Therapeutic procedure, Therapeutic Effect, Before Screening procedure; Calcitonin Therapeutic procedure, Therapeutic Effect, Before Screening procedure; Plicamycin Therapeutic procedure, Therapeutic Effect, Before Screening procedure; gallium nitrate Therapeutic procedure, Therapeutic Effect, Before Screening procedure
Item
treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of the screening csc
boolean
C0012802 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1527144 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0220908 (UMLS CUI [1,5])
C0006668 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1527144 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C0220908 (UMLS CUI [2,5])
C0026234 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1527144 (UMLS CUI [3,3])
C0332152 (UMLS CUI [3,4])
C0220908 (UMLS CUI [3,5])
C0061008 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C1527144 (UMLS CUI [4,3])
C0332152 (UMLS CUI [4,4])
C0220908 (UMLS CUI [4,5])
cinacalcet Therapeutic procedure Before Screening procedure
Item
treatment with cinacalcet within 4 weeks prior to the date of the screening csc
boolean
C1337242 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
Study Subject Participation Status, Investigational New Drugs, Previous; Study Subject Participation Status, Investigational Medical Device, Previous
Item
thirty days or less since receiving an investigational product (other than denosumab) or device (ie, does not have marketing authorization; thalidomide use is allowed) in another clinical study
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C2346570 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
Hypersensitivity, clinical trial drug
Item
known sensitivity to any of the products to be administered during the study (eg, mammalian derived products)
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Pregnancy; Breastfeeding; Pregnancy, Planned
Item
female subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Contraceptive methods, Unwilling
Item
female subject of childbearing potential is not willing to use 2 highly effective methods of contraception during treatment and for 7 months after the end of treatment
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Clinical Study Follow-up, Availability of, Unable
Item
subject will not be available for follow-up assessment.
boolean
C3274571 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Illness, Interferes withClinical Trials; Mental disorders, Interferes with Clinical Trials
Item
any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])