Eligibility NCT00332852 Breast Cancer

ODM derived from http://clinicaltrials.gov/show/NCT00332852

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age >=18 Years
Item
Alter 18 Jahre und älter, weiblich
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Compliant postmenopausal women with primary operable breast cancer after complete surgery and suitable for endocrine treatment
Item
Compliant postmenopausal women with primary operable breast cancer after complete surgery and suitable for endocrine treatment
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0566588 (UMLS CUI 2011AA)
289172004 (SNOMED CT 2011_0131)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
CL414904 (UMLS CUI 2011AA)
C0205188 (UMLS CUI 2011AA)
76234009 (SNOMED CT 2011_0131)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C0231290 (UMLS CUI 2011AA)
237679004, 255234002 (SNOMED CT 2011_0131)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0038895 (UMLS CUI 2011AA)
C0279025 (UMLS CUI 2011AA)
309542002, 169413002 (SNOMED CT 2011_0131)
10065646 (MedDRA 14.1)
Nodal status negative or positive
Item
Nodal status negative or positive
boolean
C0449927 (UMLS CUI 2011AA)
260918007 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
CL415098 (UMLS CUI 2011AA)
Good Health status <=2 (Eastern Cooperative Oncology Group)
Item
Good Health status <=2 (Eastern Cooperative Oncology Group)
boolean
C0205170 (UMLS CUI 2011AA)
20572008 (SNOMED CT 2011_0131)
C0018759 (UMLS CUI 2011AA)
406221003 (SNOMED CT 2011_0131)
C1828127 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Estrogen- and/or progesterone-receptor positive
Item
Estrogen- and/or progesterone-receptor positive
boolean
C1516974 (UMLS CUI 2011AA)
C1514471 (UMLS CUI 2011AA)
CL415097 (UMLS CUI 2011AA)
Adequate marrow, kidney and liver function
Item
Adequate marrow, kidney and liver function
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0598463 (UMLS CUI 2011AA)
MTHU027728 (LOINC Version 232)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Metastatic or inflammatory breast cancer
Item
Metastatic or inflammatory breast cancer
boolean
C0278488 (UMLS CUI 2011AA)
C0278601 (UMLS CUI 2011AA)
254840009 (SNOMED CT 2011_0131)
10021980 (MedDRA 14.1)
Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancer or in situ cancer of the cervix. Patients with other previous cancers must have been disease-free for at least 5 years and Patients with uncontrolled, non-malignant systemic cardiovascular, kidney, and liver diseases.
Item
Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancer or in situ cancer of the cervix. Patients with other previous cancers must have been disease-free for at least 5 years and Patients with uncontrolled, non-malignant systemic cardiovascular, kidney, and liver diseases.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1518422 (UMLS CUI 2011AA)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0332288 (UMLS CUI 2011AA)
45169001 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C1518371 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.
Item
Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1704330 (UMLS CUI 2011AA)
105995000 (SNOMED CT 2011_0131)
10012322 (MedDRA 14.1)
K08.9 (ICD-10-CM Version 2010)
525.9 (ICD-9-CM Version 2011)
CL425202 (UMLS CUI 2011AA)
C0877046 (UMLS CUI 2011AA)
427898007 (SNOMED CT 2011_0131)
10048762 (MedDRA 14.1)
E11594 (CTCAE 1105E)
C1400570 (UMLS CUI 2011AA)
C1301685 (UMLS CUI 2011AA)
397869004 (SNOMED CT 2011_0131)
C2363483 (UMLS CUI 2011AA)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C2711248 (UMLS CUI 2011AA)
10064658 (MedDRA 14.1)
E12502 (CTCAE 1105E)
CL428750 (UMLS CUI 2011AA)
10071014 (MedDRA 14.1)
C0439834 (UMLS CUI 2011AA)
255361000 (SNOMED CT 2011_0131)
C2004454 (UMLS CUI 2011AA)
C0231290 (UMLS CUI 2011AA)
237679004, 255234002 (SNOMED CT 2011_0131)
C0011331 (UMLS CUI 2011AA)
108306002 (SNOMED CT 2011_0131)
10061813 (MedDRA 14.1)
MTHU015835 (LOINC Version 232)
Recent (within 6 weeks) or planned dental or jaw surgery
Item
Recent (within 6 weeks) or planned dental or jaw surgery
boolean
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0204324 (UMLS CUI 2011AA)
81733005 (SNOMED CT 2011_0131)
10061812 (MedDRA 14.1)
C0524861 (UMLS CUI 2011AA)
10051059 (MedDRA 14.1)
Patients with primary overactive parathyroid
Item
Patients with primary overactive parathyroid
boolean
CL414904 (UMLS CUI 2011AA)
C0443272 (UMLS CUI 2011AA)
263829006 (SNOMED CT 2011_0131)
10033288 (MedDRA 14.1)
C0030517 (UMLS CUI 2011AA)
73132005 (SNOMED CT 2011_0131)
10033942 (MedDRA 14.1)
E21.5 (ICD-10-CM Version 2010)
252.9 (ICD-9-CM Version 2011)
Patients with a known hypersensitivity to zoledronic acid or other bisphosphonates.
Item
Patients with a known hypersensitivity to zoledronic acid or other bisphosphonates.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0257685 (UMLS CUI 2011AA)
395926009 (SNOMED CT 2011_0131)
C0012544 (UMLS CUI 2011AA)
372907000 (SNOMED CT 2011_0131)

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