ID

42681

Description

ODM derived from http://clinicaltrials.gov/show/NCT01171417

Link

http://clinicaltrials.gov/show/NCT01171417

Keywords

Versions (2)
  1. 12/6/13 12/6/13 - 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 NCT01171417 Postmenopause

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Signed written informed consent
Description

Signed written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C1519316
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
Female postmenopausal patient (or patient post-ovarectomy) and age >=18 years Postmenopause ist defined as
Description

Female postmenopausal patient (or patient post-ovarectomy) and age >=18 years Postmenopause ist defined as

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0029936
SNOMED CT 2011_0131
83152002
MedDRA 14.1
10061889
UMLS CUI 2011AA
C0206159
MedDRA 14.1
10051775
UMLS CUI 2011AA
C1704788
Age >= 60 years and natural menopause with menses > 1year ago or
Description

Age >= 60 years and natural menopause with menses > 1year ago or

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0856856
MedDRA 14.1
10028812
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0025344
SNOMED CT 2011_0131
248957007
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
FSH and E2 levels in the postmenopausal range or
Description

FSH and E2 levels in the postmenopausal range or

Data type

boolean

Alias
UMLS CUI 2011AA
C0202022
SNOMED CT 2011_0131
31003009
MedDRA 14.1
10016911
UMLS CUI 2011AA
C0337434
SNOMED CT 2011_0131
37538009
MedDRA 14.1
10030227
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C1514721
Patients who had bilateral ovariectomy (NCCN V.I. 2009)
Description

Patients who had bilateral ovariectomy (NCCN V.I. 2009)

Data type

boolean

Alias
UMLS CUI 2011AA
C0278321
SNOMED CT 2011_0131
76876009
MedDRA 14.1
10030339
ICD-9-CM Version 2011
65.51
UMLS CUI 2011AA
C1513893
Histologically confirmed ER+ locally advanced or metastatic breast cancer
Description

Histologically confirmed ER+ locally advanced or metastatic breast cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
CL415116
UMLS CUI 2011AA
C0205179
SNOMED CT 2011_0131
86005002
UMLS CUI 2011AA
C0036525
SNOMED CT 2011_0131
77879006
MedDRA 14.1
10027474
UMLS CUI 2011AA
C2938924
MedDRA 14.1
10070575
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Not eligible for curative therapy
Description

Not eligible for curative therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1555471
HL7 V3 2006_05
NELG
UMLS CUI 2011AA
C1880198
UMLS CUI 2011AA
C0039798
Prior treatment with tamoxifen
Description

Prior treatment with tamoxifen

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0039286
SNOMED CT 2011_0131
373345002
LOINC Version 232
MTHU003102
Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI
Description

Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI

Data type

boolean

Alias
UMLS CUI 2011AA
C0814634
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0279025
SNOMED CT 2011_0131
309542002, 169413002
MedDRA 14.1
10065646
UMLS CUI 2011AA
C0205179
SNOMED CT 2011_0131
86005002
UMLS CUI 2011AA
C2938924
MedDRA 14.1
10070575
UMLS CUI 2011AA
C1519228
UMLS CUI 2011AA
C1707391
UMLS CUI 2011AA
C0593802
SNOMED CT 2011_0131
108775004
Patient is able to read and understand German
Description

Patient is able to read and understand German

Data type

boolean

Alias
UMLS CUI 2011AA
C0586740
SNOMED CT 2011_0131
309251006
UMLS CUI 2011AA
C1273101
SNOMED CT 2011_0131
395659009
UMLS CUI 2011AA
C0017477
SNOMED CT 2011_0131
297490002
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Known hypersensitivity to Faslodex or Exemestan or any compounds of the drugs
Description

Known hypersensitivity to Faslodex or Exemestan or any compounds of the drugs

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0935916
SNOMED CT 2011_0131
385519002
UMLS CUI 2011AA
C0851344
SNOMED CT 2011_0131
387017005
UMLS CUI 2011AA
C0205198
SNOMED CT 2011_0131
62105006
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Prior treatment with Faslodex 500 mg or Faslodex 250 mg, for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment.
Description

Prior treatment with Faslodex 500 mg or Faslodex 250 mg, for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0935916
SNOMED CT 2011_0131
385519002
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0935916
SNOMED CT 2011_0131
385519002
Prior treatment with Exemestan for patients who receive treatment with Exemestan within this observational study
Description

Prior treatment with Exemestan for patients who receive treatment with Exemestan within this observational study

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0851344
SNOMED CT 2011_0131
387017005
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0851344
SNOMED CT 2011_0131
387017005
Acutely life threatening disease
Description

Acutely life threatening disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C2826244
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Treatment with Faslodex 250 mg/month (previously approved dose)
Description

Treatment with Faslodex 250 mg/month (previously approved dose)

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0935916
SNOMED CT 2011_0131
385519002
UMLS CUI 2011AA
C0332177
SNOMED CT 2011_0131
259036001
Prior palliative chemotherapy
Description

Prior palliative chemotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1285530
SNOMED CT 2011_0131
363676003
UMLS CUI 2011AA
C1514457
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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 at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Signed written informed consent
Item
Signed written informed consent
boolean
C1519316 (UMLS CUI 2011AA)
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
Female postmenopausal patient (or patient post-ovarectomy) and age >=18 years Postmenopause ist defined as
Item
Female postmenopausal patient (or patient post-ovarectomy) and age >=18 years Postmenopause ist defined as
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0029936 (UMLS CUI 2011AA)
83152002 (SNOMED CT 2011_0131)
10061889 (MedDRA 14.1)
C0206159 (UMLS CUI 2011AA)
10051775 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
Age >= 60 years and natural menopause with menses > 1year ago or
Item
Age >= 60 years and natural menopause with menses > 1year ago or
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0856856 (UMLS CUI 2011AA)
10028812 (MedDRA 14.1)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0025344 (UMLS CUI 2011AA)
248957007 (SNOMED CT 2011_0131)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
FSH and E2 levels in the postmenopausal range or
Item
FSH and E2 levels in the postmenopausal range or
boolean
C0202022 (UMLS CUI 2011AA)
31003009 (SNOMED CT 2011_0131)
10016911 (MedDRA 14.1)
C0337434 (UMLS CUI 2011AA)
37538009 (SNOMED CT 2011_0131)
10030227 (MedDRA 14.1)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C1514721 (UMLS CUI 2011AA)
Patients who had bilateral ovariectomy (NCCN V.I. 2009)
Item
Patients who had bilateral ovariectomy (NCCN V.I. 2009)
boolean
C0278321 (UMLS CUI 2011AA)
76876009 (SNOMED CT 2011_0131)
10030339 (MedDRA 14.1)
65.51 (ICD-9-CM Version 2011)
C1513893 (UMLS CUI 2011AA)
Histologically confirmed ER+ locally advanced or metastatic breast cancer
Item
Histologically confirmed ER+ locally advanced or metastatic breast cancer
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
CL415116 (UMLS CUI 2011AA)
C0205179 (UMLS CUI 2011AA)
86005002 (SNOMED CT 2011_0131)
C0036525 (UMLS CUI 2011AA)
77879006 (SNOMED CT 2011_0131)
10027474 (MedDRA 14.1)
C2938924 (UMLS CUI 2011AA)
10070575 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Not eligible for curative therapy
Item
Not eligible for curative therapy
boolean
C1555471 (UMLS CUI 2011AA)
NELG (HL7 V3 2006_05)
C1880198 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Prior treatment with tamoxifen
Item
Prior treatment with tamoxifen
boolean
C1514463 (UMLS CUI 2011AA)
C0039286 (UMLS CUI 2011AA)
373345002 (SNOMED CT 2011_0131)
MTHU003102 (LOINC Version 232)
Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI
Item
Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI
boolean
C0814634 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C0279025 (UMLS CUI 2011AA)
309542002, 169413002 (SNOMED CT 2011_0131)
10065646 (MedDRA 14.1)
C0205179 (UMLS CUI 2011AA)
86005002 (SNOMED CT 2011_0131)
C2938924 (UMLS CUI 2011AA)
10070575 (MedDRA 14.1)
C1519228 (UMLS CUI 2011AA)
C1707391 (UMLS CUI 2011AA)
C0593802 (UMLS CUI 2011AA)
108775004 (SNOMED CT 2011_0131)
Patient is able to read and understand German
Item
Patient is able to read and understand German
boolean
C0586740 (UMLS CUI 2011AA)
309251006 (SNOMED CT 2011_0131)
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0017477 (UMLS CUI 2011AA)
297490002 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Known hypersensitivity to Faslodex or Exemestan or any compounds of the drugs
Item
Known hypersensitivity to Faslodex or Exemestan or any compounds of the drugs
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0935916 (UMLS CUI 2011AA)
385519002 (SNOMED CT 2011_0131)
C0851344 (UMLS CUI 2011AA)
387017005 (SNOMED CT 2011_0131)
C0205198 (UMLS CUI 2011AA)
62105006 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Prior treatment with Faslodex 500 mg or Faslodex 250 mg, for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment.
Item
Prior treatment with Faslodex 500 mg or Faslodex 250 mg, for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment.
boolean
C1514463 (UMLS CUI 2011AA)
C0935916 (UMLS CUI 2011AA)
385519002 (SNOMED CT 2011_0131)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0935916 (UMLS CUI 2011AA)
385519002 (SNOMED CT 2011_0131)
Prior treatment with Exemestan for patients who receive treatment with Exemestan within this observational study
Item
Prior treatment with Exemestan for patients who receive treatment with Exemestan within this observational study
boolean
C1514463 (UMLS CUI 2011AA)
C0851344 (UMLS CUI 2011AA)
387017005 (SNOMED CT 2011_0131)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0851344 (UMLS CUI 2011AA)
387017005 (SNOMED CT 2011_0131)
Acutely life threatening disease
Item
Acutely life threatening disease
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C2826244 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Treatment with Faslodex 250 mg/month (previously approved dose)
Item
Treatment with Faslodex 250 mg/month (previously approved dose)
boolean
C0039798 (UMLS CUI 2011AA)
C0935916 (UMLS CUI 2011AA)
385519002 (SNOMED CT 2011_0131)
C0332177 (UMLS CUI 2011AA)
259036001 (SNOMED CT 2011_0131)
Prior palliative chemotherapy
Item
Prior palliative chemotherapy
boolean
C1285530 (UMLS CUI 2011AA)
363676003 (SNOMED CT 2011_0131)
C1514457 (UMLS CUI 2011AA)
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