Information:
Fel:
ID
18996
Beskrivning
Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00219219
Länk
https://clinicaltrials.gov/show/NCT00219219
Nyckelord
Versioner (1)
- 2016-11-29 2016-11-29 -
Uppladdad den
29 november 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00219219
Eligibility Prostate Cancer NCT00219219
- StudyEvent: Eligibility
Similar models
Eligibility Prostate Cancer NCT00219219
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Age
Item
patients aged ≥18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Prostate carcinoma
Item
histologically-proven prostate carcinoma
boolean
C0600139 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Secondary malignant neoplasm of bone Scan of bone | Secondary malignant neoplasm of bone Radiographic imaging procedure
Item
newly diagnosed (≤ 6 months prior to visit 1) bone metastases evidenced by bone scan or radiograph.
boolean
C0153690 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2,1])
C1962945 (UMLS CUI [2,2])
C0203668 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2,1])
C1962945 (UMLS CUI [2,2])
Antiandrogen therapy | Luteinizing Hormone-releasing Hormone Agonist
Item
patients on androgen deprivation therapy (medical therapy with lhrh analogues +
boolean
C0279492 (UMLS CUI [1])
C1518041 (UMLS CUI [2])
C1518041 (UMLS CUI [2])
Androgen Antagonists | Male Castration
Item
antiandrogens or surgical castration) or going to start it
boolean
C0002842 (UMLS CUI [1])
C0007347 (UMLS CUI [2])
C0007347 (UMLS CUI [2])
Partner Childbearing Potential Contraception, Barrier
Item
patients with partners of childbearing potential should use a barrier method of contraception throughout the study
boolean
C0682323 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0004764 (UMLS CUI [1,3])
C3831118 (UMLS CUI [1,2])
C0004764 (UMLS CUI [1,3])
Secondary malignant neoplasm of bone
Item
patients without a history of metastatic disease to the bone
boolean
C0153690 (UMLS CUI [1])
Diphosphonates
Item
prior treatment with bisphosphonates
boolean
C0012544 (UMLS CUI [1])
Events Skeletal Related
Item
sres prior to visit 2
boolean
C0441471 (UMLS CUI [1,1])
C0521324 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0521324 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Calcitonin | Mithramycin | gallium nitrate
Item
prior treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to baseline
boolean
C0006668 (UMLS CUI [1])
C0026234 (UMLS CUI [2])
C0061008 (UMLS CUI [3])
C0026234 (UMLS CUI [2])
C0061008 (UMLS CUI [3])
Corrected serum calcium measurement | Serum albumin measurement
Item
corrected (adjusted for serum albumin - see appendix 5 for the calculation) serum calcium concentration < 8.0 mg/dl (2.00 mmol/l)
boolean
C0455288 (UMLS CUI [1])
C0523465 (UMLS CUI [2])
C0523465 (UMLS CUI [2])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Kidney Disease Serious | Kidney Transplantation
Item
serum creatinine concentration > 265 micromol/l (3.0 mg/dl) or a calculated creatinine clearance < 30 ml/minute or serious underlying renal disease or prior renal transplantation
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
C0022658 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0022671 (UMLS CUI [4])
C2711451 (UMLS CUI [2])
C0022658 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0022671 (UMLS CUI [4])
Malignant Neoplasms | Skin carcinoma Treated
Item
history of other malignant neoplasm within previous five years with exception of non-melanomatous skin cancer which has been satisfactorily treated
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Life threatening illness
Item
other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future
boolean
C3846017 (UMLS CUI [1])
Investigational New Drugs Systemic | Investigational Medical Device Systemic | Investigational New Drugs Topical
Item
patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days
boolean
C0013230 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2346570 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C1522168 (UMLS CUI [3,2])
C0205373 (UMLS CUI [1,2])
C2346570 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C1522168 (UMLS CUI [3,2])
Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates
Item
known hypersensitivity to zoledronic acid or other bisphosphonates
boolean
C0020517 (UMLS CUI [1,1])
C0257685 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0012544 (UMLS CUI [2,2])
C0257685 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0012544 (UMLS CUI [2,2])
Protocol Compliance Unwilling | Substance Use Disorders | Informed Consent Unable
Item
history of noncompliance to medical regimens and patients who are considered potentially unreliable (for example drug or alchohol abusers) or incapable of giving informed consent as judged by the investigator
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0558080 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])