ID

42848

Description

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

Link

http://clinicaltrials.gov/show/NCT00332852

Keywords

Versions (2)
  1. 12/11/13 12/11/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00332852 Breast Cancer

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
Age 18 Years and older, female
Description

age >=18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Compliant postmenopausal women with primary operable breast cancer after complete surgery and suitable for endocrine treatment
Description

Compliant postmenopausal women with primary operable breast cancer after complete surgery and suitable for endocrine treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0566588
SNOMED CT 2011_0131
289172004
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0205188
SNOMED CT 2011_0131
76234009
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004, 255234002
UMLS CUI 2011AA
C0205197
SNOMED CT 2011_0131
255594003
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0279025
SNOMED CT 2011_0131
309542002, 169413002
MedDRA 14.1
10065646
Nodal status negative or positive
Description

Nodal status negative or positive

Data type

boolean

Alias
UMLS CUI 2011AA
C0449927
SNOMED CT 2011_0131
260918007
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
CL415098
Good Health status <=2 (Eastern Cooperative Oncology Group)
Description

Good Health status <=2 (Eastern Cooperative Oncology Group)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205170
SNOMED CT 2011_0131
20572008
UMLS CUI 2011AA
C0018759
SNOMED CT 2011_0131
406221003
UMLS CUI 2011AA
C1828127
SNOMED CT 2011_0131
424122007
Estrogen- and/or progesterone-receptor positive
Description

Estrogen- and/or progesterone-receptor positive

Data type

boolean

Alias
UMLS CUI 2011AA
C1516974
UMLS CUI 2011AA
C1514471
UMLS CUI 2011AA
CL415097
Adequate marrow, kidney and liver function
Description

Adequate marrow, kidney and liver function

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0598463
LOINC Version 232
MTHU027728
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Metastatic or inflammatory breast cancer
Description

Metastatic or inflammatory breast cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C0278488
UMLS CUI 2011AA
C0278601
SNOMED CT 2011_0131
254840009
MedDRA 14.1
10021980
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
UMLS CUI 2011AA
C0332288
SNOMED CT 2011_0131
45169001
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C1518371
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C1704330
SNOMED CT 2011_0131
105995000
MedDRA 14.1
10012322
ICD-10-CM Version 2010
K08.9
ICD-9-CM Version 2011
525.9
UMLS CUI 2011AA
CL425202
UMLS CUI 2011AA
C0877046
SNOMED CT 2011_0131
427898007
MedDRA 14.1
10048762
CTCAE 1105E
E11594
UMLS CUI 2011AA
C1400570
UMLS CUI 2011AA
C1301685
SNOMED CT 2011_0131
397869004
UMLS CUI 2011AA
C2363483
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C2711248
MedDRA 14.1
10064658
CTCAE 1105E
E12502
UMLS CUI 2011AA
CL428750
MedDRA 14.1
10071014
UMLS CUI 2011AA
C0439834
SNOMED CT 2011_0131
255361000
UMLS CUI 2011AA
C2004454
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004, 255234002
UMLS CUI 2011AA
C0011331
SNOMED CT 2011_0131
108306002
MedDRA 14.1
10061813
LOINC Version 232
MTHU015835
Recent (within 6 weeks) or planned dental or jaw surgery
Description

Recent (within 6 weeks) or planned dental or jaw surgery

Data type

boolean

Alias
UMLS CUI 2011AA
C0332185
SNOMED CT 2011_0131
6493001
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0204324
SNOMED CT 2011_0131
81733005
MedDRA 14.1
10061812
UMLS CUI 2011AA
C0524861
MedDRA 14.1
10051059
Patients with primary overactive parathyroid
Description

Patients with primary overactive parathyroid

Data type

boolean

Alias
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0443272
SNOMED CT 2011_0131
263829006
MedDRA 14.1
10033288
UMLS CUI 2011AA
C0030517
SNOMED CT 2011_0131
73132005
MedDRA 14.1
10033942
ICD-10-CM Version 2010
E21.5
ICD-9-CM Version 2011
252.9
Patients with a known hypersensitivity to zoledronic acid or other bisphosphonates.
Description

Patients with a known hypersensitivity to zoledronic acid or other bisphosphonates.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0257685
SNOMED CT 2011_0131
395926009
UMLS CUI 2011AA
C0012544
SNOMED CT 2011_0131
372907000
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age >=18 Years
Item
Age 18 Years and older, female
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
Exclusion Criteria
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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