ID

4404

Beschrijving

ODM derived from http://clinicaltrials.gov/show/NCT00857012

Link

http://clinicaltrials.gov/show/NCT00857012

Trefwoorden

Versies (2)
  1. 09-12-13 09-12-13 - Martin Dugas
  2. 16-12-14 16-12-14 - Martin Dugas
Geüploaded op

9 december 2013

DOI

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Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00857012 Breast Cancer

Duits Engels

Eligibility

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschrijving

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Beschrijving

age at least 18 Years

Datatype

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Postmenopausal women aged 18 years or older. Postmenopause is defined as Natural menopause with menses >1 year ago or Serum FSH (> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy
Beschrijving

Postmenopausal women aged 18 years or older. Postmenopause is defined as Natural menopause with menses >1 year ago or Serum FSH (> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy

Datatype

boolean

Alias
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0856856
MedDRA 14.1
10028812
UMLS CUI 2011AA
C0025344
SNOMED CT 2011_0131
248957007
UMLS CUI 2011AA
C0229671
SNOMED CT 2011_0131
67922002
LOINC Version 232
MTHU001009
UMLS CUI 2011AA
C0733758
SNOMED CT 2011_0131
25217009
LOINC Version 232
MTHU003493
UMLS CUI 2011AA
C0337434
SNOMED CT 2011_0131
37538009
MedDRA 14.1
10030227
UMLS CUI 2011AA
C0278321
SNOMED CT 2011_0131
76876009
MedDRA 14.1
10030339
ICD-9-CM Version 2011
65.51
Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)
Beschrijving

Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0205471
SNOMED CT 2011_0131
40413002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0801658
LOINC Version 232
18630-4
UMLS CUI 2011AA
C1279919
SNOMED CT 2011_0131
264499004
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
UMLS CUI 2011AA
C0445034
SNOMED CT 2011_0131
30893008
UMLS CUI 2011AA
C0920555
UMLS CUI 2011AA
C1562312
SNOMED CT 2011_0131
416053008
UMLS CUI 2011AA
C1562928
SNOMED CT 2011_0131
416561008
Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months
Beschrijving

Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months

Datatype

boolean

Alias
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0600558
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0085533
UMLS CUI 2011AA
C0281266
UMLS CUI 2011AA
C0290883
SNOMED CT 2011_0131
108774000
UMLS CUI 2011AA
C0039286
SNOMED CT 2011_0131
373345002
LOINC Version 232
MTHU003102
In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years.
Beschrijving

In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years.

Datatype

boolean

Alias
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0039286
SNOMED CT 2011_0131
373345002
LOINC Version 232
MTHU003102
UMLS CUI 2011AA
C0444917
SNOMED CT 2011_0131
261773006
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Ausschlusskriterien
Beschrijving

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Patients with severe renal function disorders (Creatinine clearance < 20 ml/min or Patients with moderate or severe disorders of hepatic function
Beschrijving

Patients with severe renal function disorders (Creatinine clearance < 20 ml/min or Patients with moderate or severe disorders of hepatic function

Datatype

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1848822
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
UMLS CUI 2011AA
C1299393
SNOMED CT 2011_0131
371924009
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
Beschrijving

Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen

Datatype

boolean

Alias
UMLS CUI 2011AA
C1707479
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0036884
SNOMED CT 2011_0131
312263009
UMLS CUI 2011AA
C0449438
SNOMED CT 2011_0131
263490005
LOINC Version 232
MTHU015827
UMLS CUI 2011AA
C0039286
SNOMED CT 2011_0131
373345002
LOINC Version 232
MTHU003102
Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)
Beschrijving

Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)

Datatype

boolean

Alias
UMLS CUI 2011AA
C0007124
SNOMED CT 2011_0131
86616005
MedDRA 14.1
10013806
ICD-10-CM Version 2010
D05.1
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0801658
LOINC Version 232
18630-4
UMLS CUI 2011AA
C1279919
SNOMED CT 2011_0131
264499004
UMLS CUI 2011AA
C0678222
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
UMLS CUI 2011AA
C0445034
SNOMED CT 2011_0131
30893008
Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program
Beschrijving

Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program

Datatype

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0587081
SNOMED CT 2011_0131
118246004
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1548788
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C1709697
Terug naar het begin van de pagina

Similar models

Eligibility

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Postmenopausal women aged 18 years or older. Postmenopause is defined as Natural menopause with menses >1 year ago or Serum FSH (> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy
Item
Postmenopausal women aged 18 years or older. Postmenopause is defined as Natural menopause with menses >1 year ago or Serum FSH (> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy
boolean
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0856856 (UMLS CUI 2011AA)
10028812 (MedDRA 14.1)
C0025344 (UMLS CUI 2011AA)
248957007 (SNOMED CT 2011_0131)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
C0733758 (UMLS CUI 2011AA)
25217009 (SNOMED CT 2011_0131)
MTHU003493 (LOINC Version 232)
C0337434 (UMLS CUI 2011AA)
37538009 (SNOMED CT 2011_0131)
10030227 (MedDRA 14.1)
C0278321 (UMLS CUI 2011AA)
76876009 (SNOMED CT 2011_0131)
10030339 (MedDRA 14.1)
65.51 (ICD-9-CM Version 2011)
Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)
Item
Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0801658 (UMLS CUI 2011AA)
18630-4 (LOINC Version 232)
C1279919 (UMLS CUI 2011AA)
264499004 (SNOMED CT 2011_0131)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C0445034 (UMLS CUI 2011AA)
30893008 (SNOMED CT 2011_0131)
C0920555 (UMLS CUI 2011AA)
C1562312 (UMLS CUI 2011AA)
416053008 (SNOMED CT 2011_0131)
C1562928 (UMLS CUI 2011AA)
416561008 (SNOMED CT 2011_0131)
Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months
Item
Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months
boolean
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C0038895 (UMLS CUI 2011AA)
C0034619 (UMLS CUI 2011AA)
C0600558 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0085533 (UMLS CUI 2011AA)
C0281266 (UMLS CUI 2011AA)
C0290883 (UMLS CUI 2011AA)
108774000 (SNOMED CT 2011_0131)
C0039286 (UMLS CUI 2011AA)
373345002 (SNOMED CT 2011_0131)
MTHU003102 (LOINC Version 232)
In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years.
Item
In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years.
boolean
C0750557 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C0039286 (UMLS CUI 2011AA)
373345002 (SNOMED CT 2011_0131)
MTHU003102 (LOINC Version 232)
C0444917 (UMLS CUI 2011AA)
261773006 (SNOMED CT 2011_0131)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Patients with severe renal function disorders (Creatinine clearance < 20 ml/min or Patients with moderate or severe disorders of hepatic function
Item
Patients with severe renal function disorders (Creatinine clearance < 20 ml/min or Patients with moderate or severe disorders of hepatic function
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1848822 (UMLS CUI 2011AA)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C1299393 (UMLS CUI 2011AA)
371924009 (SNOMED CT 2011_0131)
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
Item
Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
boolean
C1707479 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0036884 (UMLS CUI 2011AA)
312263009 (SNOMED CT 2011_0131)
C0449438 (UMLS CUI 2011AA)
263490005 (SNOMED CT 2011_0131)
MTHU015827 (LOINC Version 232)
C0039286 (UMLS CUI 2011AA)
373345002 (SNOMED CT 2011_0131)
MTHU003102 (LOINC Version 232)
Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)
Item
Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)
boolean
C0007124 (UMLS CUI 2011AA)
86616005 (SNOMED CT 2011_0131)
10013806 (MedDRA 14.1)
D05.1 (ICD-10-CM Version 2010)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0801658 (UMLS CUI 2011AA)
18630-4 (LOINC Version 232)
C1279919 (UMLS CUI 2011AA)
264499004 (SNOMED CT 2011_0131)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C0445034 (UMLS CUI 2011AA)
30893008 (SNOMED CT 2011_0131)
Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program
Item
Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0587081 (UMLS CUI 2011AA)
118246004 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1548788 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C1709697 (UMLS CUI 2011AA)
Terug naar het begin van de pagina 

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