Eligibility Breast Cancer NCT00896454

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StudyEvent: Eligibility
1. Eligibility Breast Cancer NCT00896454

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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])

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Eligibility Breast Cancer NCT00896454