ID

6185

Beskrivning

Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT): An in Practice Assessment of Arthralgias and Related Costs as Well as Compliance in the First Year of Anastrozole Therapy ODM derived from http://clinicaltrials.gov/show/NCT00857012

Länk

http://clinicaltrials.gov/show/NCT00857012

Nyckelord

Versioner (2)
  1. 2013-12-09 2013-12-09 - Martin Dugas
  2. 2014-12-16 2014-12-16 - Martin Dugas
Uppladdad den

16 december 2014

DOI

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Licens

Creative Commons BY 4.0
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Eligibility NCT00857012 Breast Cancer Anastrozole Therapy (COMPACT)

Tysk Engelsk

Eligibility NCT00857012 Breast Cancer Anastrozole Therapy (COMPACT)

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
age at least 18 Years
Beskrivning

age at least 18 Years

Datatyp

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
Beskrivning

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

Datatyp

boolean

Alias
SNOMED CT 2011_0131
76498008
SNOMED CT 2011_0131
224526002
MedDRA 14.1
10028812
SNOMED CT 2011_0131
248957007
SNOMED CT 2011_0131
67922002
LOINC Version 232
MTHU001009
SNOMED CT 2011_0131
25217009
LOINC Version 232
MTHU003493
SNOMED CT 2011_0131
37538009
MedDRA 14.1
10030227
SNOMED CT 2011_0131
76876009
MedDRA 14.1
10030339
ICD-9-CM Version 2011
65.51
UMLS CUI-1
C0232970
Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)
Beskrivning

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

Datatyp

boolean

Alias
SNOMED CT 2011_0131
67151002
SNOMED CT 2011_0131
40413002
LOINC Version 232
18630-4
SNOMED CT 2011_0131
264499004
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
SNOMED CT 2011_0131
30893008
SNOMED CT 2011_0131
416053008
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
Beskrivning

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

Datatyp

boolean

Alias
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
SNOMED CT 2011_0131
150415003
SNOMED CT 2011_0131
108774000
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.
Beskrivning

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

Datatyp

boolean

Alias
SNOMED CT 2011_0131
373345002
LOINC Version 232
MTHU003102
SNOMED CT 2011_0131
261773006
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
SNOMED CT 2011_0131
19338005
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Patients with severe renal function disorders (Creatinine clearance < 20 ml/min or Patients with moderate or severe disorders of hepatic function
Beskrivning

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

Datatyp

boolean

Alias
SNOMED CT 2011_0131
24484000
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
SNOMED CT 2011_0131
371924009
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
Beskrivning

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

Datatyp

boolean

Alias
SNOMED CT 2011_0131
247591002
SNOMED CT 2011_0131
312263009
SNOMED CT 2011_0131
263490005
LOINC Version 232
MTHU015827
SNOMED CT 2011_0131
373345002
LOINC Version 232
MTHU003102
Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)
Beskrivning

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

Datatyp

boolean

Alias
SNOMED CT 2011_0131
86616005
MedDRA 14.1
10013806
ICD-10-CM Version 2010
D05.1
SNOMED CT 2011_0131
2667000
LOINC Version 232
18630-4
SNOMED CT 2011_0131
264499004
SNOMED CT 2011_0131
254838004
MedDRA 14.1
10006204
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
Beskrivning

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

Datatyp

boolean

Alias
SNOMED CT 2011_0131
18669006
SNOMED CT 2011_0131
386134007
SNOMED CT 2011_0131
58147004
SNOMED CT 2011_0131
64572001
SNOMED CT 2011_0131
118246004
SNOMED CT 2011_0131
116154003
HL7 V3 2006_05
PART
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Similar models

Eligibility NCT00857012 Breast Cancer Anastrozole Therapy (COMPACT)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Postmenopausal women
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
76498008 (SNOMED CT 2011_0131)
224526002 (SNOMED CT 2011_0131)
10028812 (MedDRA 14.1)
248957007 (SNOMED CT 2011_0131)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
25217009 (SNOMED CT 2011_0131)
MTHU003493 (LOINC Version 232)
37538009 (SNOMED CT 2011_0131)
10030227 (MedDRA 14.1)
76876009 (SNOMED CT 2011_0131)
10030339 (MedDRA 14.1)
65.51 (ICD-9-CM Version 2011)
C0232970 (UMLS CUI-1)
Confirmed primary diagnosis of early breast cancer with hormone sensitive tumour
Item
Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)
boolean
67151002 (SNOMED CT 2011_0131)
40413002 (SNOMED CT 2011_0131)
18630-4 (LOINC Version 232)
264499004 (SNOMED CT 2011_0131)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
30893008 (SNOMED CT 2011_0131)
416053008 (SNOMED CT 2011_0131)
416561008 (SNOMED CT 2011_0131)
Breast cancer surgery and anastrozole therapy
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
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
150415003 (SNOMED CT 2011_0131)
108774000 (SNOMED CT 2011_0131)
373345002 (SNOMED CT 2011_0131)
MTHU003102 (LOINC Version 232)
Tamoxifen treatment between two and 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
373345002 (SNOMED CT 2011_0131)
MTHU003102 (LOINC Version 232)
261773006 (SNOMED CT 2011_0131)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
19338005 (SNOMED CT 2011_0131)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Severe renal or hepatic disorders
Item
Patients with severe renal function disorders (Creatinine clearance < 20 ml/min or Patients with moderate or severe disorders of hepatic function
boolean
24484000 (SNOMED CT 2011_0131)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
371924009 (SNOMED CT 2011_0131)
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
247591002 (SNOMED CT 2011_0131)
312263009 (SNOMED CT 2011_0131)
263490005 (SNOMED CT 2011_0131)
MTHU015827 (LOINC Version 232)
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
86616005 (SNOMED CT 2011_0131)
10013806 (MedDRA 14.1)
D05.1 (ICD-10-CM Version 2010)
2667000 (SNOMED CT 2011_0131)
18630-4 (LOINC Version 232)
264499004 (SNOMED CT 2011_0131)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
30893008 (SNOMED CT 2011_0131)
Any significant clinical disorder or laboratory finding interfering with trial
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
18669006 (SNOMED CT 2011_0131)
386134007 (SNOMED CT 2011_0131)
58147004 (SNOMED CT 2011_0131)
64572001 (SNOMED CT 2011_0131)
118246004 (SNOMED CT 2011_0131)
116154003 (SNOMED CT 2011_0131)
PART (HL7 V3 2006_05)
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