ID

43344

Description

ODM derived from http://clinicaltrials.gov/show/NCT00321620

Link

http://clinicaltrials.gov/show/NCT00321620

Keywords

Versions (3)
  1. 3/21/12 3/21/12 -
  2. 4/14/14 4/14/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00009676 NCT00324662 Tachyarrhythmia

German English

Eligibility

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

Inclusion Criteria

Age 18 Years and older
Description

age >=18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Men >/= 18 years of age with histologically confirmed prostate cancer
Description

Men >/= 18 years of age with histologically confirmed prostate cancer

Data type

boolean

Alias
UMLS CUI 1
C0011900
SNOMED CT 1
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2
C0086582
SNOMED CT 2
248153007
UMLS CUI 3
C0205462
SNOMED CT 3
67151002
UMLS CUI 4
C0750484
UMLS CUI 5
C0600139
SNOMED CT 4
254900004
MedDRA 14.1
10036921
Radiographic evidence of at least one bone metastasis
Description

Radiographic evidence of at least one bone metastasis

Data type

boolean

Alias
UMLS CUI 1
C0153690
SNOMED CT 1
94222008
MedDRA 14.1
10055101
ICD-10-CM Version 2010
C79.51
ICD-9-CM Version 2011
198.5
UMLS CUI 2
C0444708
SNOMED CT 2
258106000
UMLS CUI 3
C0332120
SNOMED CT 3
18669006
Failure of at least one hormonal therapy as evidenced by a rising PSA
Description

Failure of at least one hormonal therapy as evidenced by a rising PSA

Data type

boolean

Alias
UMLS CUI 1
C0231174
SNOMED CT 1
76797004
UMLS CUI 2
C0279025
SNOMED CT 2
169413002
MedDRA 14.1
10065646
UMLS CUI 3
C0332120
SNOMED CT 3
18669006
UMLS CUI 4
C0138741
SNOMED CT 4
102687007
LOINC Version 232
MTHU001466
Serum testosterone level of <50 ng/dL
Description

Serum testosterone level of <50 ng/dL

Data type

boolean

Alias
UMLS CUI 1
C0857983
MedDRA 1
10040411
UMLS CUI 2
C0428413
SNOMED CT 2
270973006
MedDRA 2
10040409
ECOG performance 0,1 or 2
Description

ECOG <= 2

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
Adequate organ function
Description

Adequate organ function

Data type

boolean

Alias
UMLS CUI 1
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Current or prior IV bisphosphonate administration
Description

Current or prior IV bisphosphonate administration

Data type

boolean

Alias
UMLS CUI 1
C0521116
SNOMED CT 1
15240007
UMLS CUI 2
C0332152
SNOMED 2
288556008
UMLS CUI 3
C0013125
UMLS CUI 4
C0012544
SNOMED CT 3
372907000
Current or prior oral bisphosphonates for bone mets
Description

Current or prior oral bisphosphonates for bone mets

Data type

boolean

Alias
UMLS CUI 1
C0521116
SNOMED CT 1
15240007
UMLS CUI 2
C0332152
SNOMED CT 2
288556008
UMLS CUI 3
C1527415
SNOMED CT 3
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 4
C0012544
SNOMED CT 4
372907000
UMLS CUI 5
C0153690
SNOMED CT 5
94222008
MedDRA 14.1
10055101
ICD-10-CM Version 2010
C79.51
ICD-9-CM Version 2011
198.5
life expectancy <6 months
Description

life expectancy of less than 6 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
MTHU032184
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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
age >=18 Years
Item
Age 18 Years and older
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Men >/= 18 years of age with histologically confirmed prostate cancer
Item
Men >/= 18 years of age with histologically confirmed prostate cancer
boolean
C0011900 (UMLS CUI 1)
439401001 (SNOMED CT 1)
MTHU008876 (LOINC Version 232)
C0086582 (UMLS CUI 2)
248153007 (SNOMED CT 2)
C0205462 (UMLS CUI 3)
67151002 (SNOMED CT 3)
C0750484 (UMLS CUI 4)
C0600139 (UMLS CUI 5)
254900004 (SNOMED CT 4)
10036921 (MedDRA 14.1)
Radiographic evidence of at least one bone metastasis
Item
Radiographic evidence of at least one bone metastasis
boolean
C0153690 (UMLS CUI 1)
94222008 (SNOMED CT 1)
10055101 (MedDRA 14.1)
C79.51 (ICD-10-CM Version 2010)
198.5 (ICD-9-CM Version 2011)
C0444708 (UMLS CUI 2)
258106000 (SNOMED CT 2)
C0332120 (UMLS CUI 3)
18669006 (SNOMED CT 3)
Failure of at least one hormonal therapy as evidenced by a rising PSA
Item
Failure of at least one hormonal therapy as evidenced by a rising PSA
boolean
C0231174 (UMLS CUI 1)
76797004 (SNOMED CT 1)
C0279025 (UMLS CUI 2)
169413002 (SNOMED CT 2)
10065646 (MedDRA 14.1)
C0332120 (UMLS CUI 3)
18669006 (SNOMED CT 3)
C0138741 (UMLS CUI 4)
102687007 (SNOMED CT 4)
MTHU001466 (LOINC Version 232)
Serum testosterone level of <50 ng/dL
Item
Serum testosterone level of <50 ng/dL
boolean
C0857983 (UMLS CUI 1)
10040411 (MedDRA 1)
C0428413 (UMLS CUI 2)
270973006 (SNOMED CT 2)
10040409 (MedDRA 2)
ECOG <= 2
Item
ECOG performance 0,1 or 2
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Adequate organ function
Item
Adequate organ function
boolean
C0205411 (UMLS CUI 1)
88323005 (SNOMED CT 2011_0131)
C0678852 (UMLS CUI 2)
Item Group
Exclusion Criteria
Current or prior IV bisphosphonate administration
Item
Current or prior IV bisphosphonate administration
boolean
C0521116 (UMLS CUI 1)
15240007 (SNOMED CT 1)
C0332152 (UMLS CUI 2)
288556008 (SNOMED 2)
C0013125 (UMLS CUI 3)
C0012544 (UMLS CUI 4)
372907000 (SNOMED CT 3)
Current or prior oral bisphosphonates for bone mets
Item
Current or prior oral bisphosphonates for bone mets
boolean
C0521116 (UMLS CUI 1)
15240007 (SNOMED CT 1)
C0332152 (UMLS CUI 2)
288556008 (SNOMED CT 2)
C1527415 (UMLS CUI 3)
26643006 (SNOMED CT 3)
_OralRoute (HL7 V3 2006_05)
C0012544 (UMLS CUI 4)
372907000 (SNOMED CT 4)
C0153690 (UMLS CUI 5)
94222008 (SNOMED CT 5)
10055101 (MedDRA 14.1)
C79.51 (ICD-10-CM Version 2010)
198.5 (ICD-9-CM Version 2011)
life expectancy of less than 6 months
Item
life expectancy <6 months
boolean
C0023671 (UMLS CUI 2011AA)
MTHU032184 (LOINC Version 232)
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