ID

4392

Description

ODM derived from http://clinicaltrials.gov/show/NCT00887198

Link

http://clinicaltrials.gov/show/NCT00887198

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00887198 Prostate Cancer

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
Metastatic castration-resistant prostate cancer
Description

Metastatic castration-resistant prostate cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C0007347
SNOMED CT 2011_0131
275234001
UMLS CUI 2011AA
C0332325
SNOMED CT 2011_0131
30714006
UMLS CUI 2011AA
C0936223
MedDRA 14.1
10036909
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Previous anti-androgen therapy and progression after withdrawal
Description

Previous anti-androgen therapy and progression after withdrawal

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0279492
MedDRA 14.1
10002730
UMLS CUI 2011AA
C0242656
SNOMED CT 2011_0131
246453008
MedDRA 14.1
10061818
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C2349954
ECOG performance status of either 0 or 1
Description

ECOG performance status of either 0 or 1

Data type

boolean

Alias
UMLS CUI 2011AA
C1828078
SNOMED CT 2011_0131
425389002
UMLS CUI 2011AA
C1827388
SNOMED CT 2011_0131
422512005
Medical or surgical castration with testosterone < 50 ng/dL
Description

Medical or surgical castration with testosterone < 50 ng/dL

Data type

boolean

Alias
UMLS CUI 2011AA
C1513054
UMLS CUI 2011AA
C0007347
SNOMED CT 2011_0131
275234001
UMLS CUI 2011AA
CL026906
Able to provide written informed consent
Description

Able to provide written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Prior cytotoxic chemotherapy or biologic therapy for CRPC
Description

Prior cytotoxic chemotherapy or biologic therapy for CRPC

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0677881
UMLS CUI 2011AA
C0005527
UMLS CUI 2011AA
C0007347
SNOMED CT 2011_0131
275234001
UMLS CUI 2011AA
C0332325
SNOMED CT 2011_0131
30714006
UMLS CUI 2011AA
C0936223
MedDRA 14.1
10036909
Prior ketoconazole for prostate cancer
Description

Prior ketoconazole for prostate cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0022625
SNOMED CT 2011_0131
387216007
LOINC Version 232
MTHU002299
UMLS CUI 2011AA
C0600139
SNOMED CT 2011_0131
254900004
MedDRA 14.1
10036921
Known brain metastasis or visceral organ metastasis
Description

Known brain metastasis or visceral organ metastasis

Data type

boolean

Alias
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
UMLS CUI 2011AA
C0042779
UMLS CUI 2011AA
C0027627
SNOMED CT 2011_0131
128462008
MedDRA 14.1
10027449
Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
Description

Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1

Data type

boolean

Alias
UMLS CUI 2011AA
C2911207
ICD-10-CM Version 2010
Z79.891
UMLS CUI 2011AA
C1719395
ICD-10-CM Version 2010
G89.3
ICD-9-CM Version 2011
338.3
UMLS CUI 2011AA
C0009214
SNOMED CT 2011_0131
85990009
LOINC Version 232
MTHU004289
UMLS CUI 2011AA
C0033493
SNOMED CT 2011_0131
117005003
LOINC Version 232
MTHU001004
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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)
Metastatic castration-resistant prostate cancer
Item
Metastatic castration-resistant prostate cancer
boolean
C0007347 (UMLS CUI 2011AA)
275234001 (SNOMED CT 2011_0131)
C0332325 (UMLS CUI 2011AA)
30714006 (SNOMED CT 2011_0131)
C0936223 (UMLS CUI 2011AA)
10036909 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Previous anti-androgen therapy and progression after withdrawal
Item
Previous anti-androgen therapy and progression after withdrawal
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0279492 (UMLS CUI 2011AA)
10002730 (MedDRA 14.1)
C0242656 (UMLS CUI 2011AA)
246453008 (SNOMED CT 2011_0131)
10061818 (MedDRA 14.1)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C2349954 (UMLS CUI 2011AA)
ECOG performance status of either 0 or 1
Item
ECOG performance status of either 0 or 1
boolean
C1828078 (UMLS CUI 2011AA)
425389002 (SNOMED CT 2011_0131)
C1827388 (UMLS CUI 2011AA)
422512005 (SNOMED CT 2011_0131)
Medical or surgical castration with testosterone < 50 ng/dL
Item
Medical or surgical castration with testosterone < 50 ng/dL
boolean
C1513054 (UMLS CUI 2011AA)
C0007347 (UMLS CUI 2011AA)
275234001 (SNOMED CT 2011_0131)
CL026906 (UMLS CUI 2011AA)
Able to provide written informed consent
Item
Able to provide written informed consent
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Prior cytotoxic chemotherapy or biologic therapy for CRPC
Item
Prior cytotoxic chemotherapy or biologic therapy for CRPC
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0677881 (UMLS CUI 2011AA)
C0005527 (UMLS CUI 2011AA)
C0007347 (UMLS CUI 2011AA)
275234001 (SNOMED CT 2011_0131)
C0332325 (UMLS CUI 2011AA)
30714006 (SNOMED CT 2011_0131)
C0936223 (UMLS CUI 2011AA)
10036909 (MedDRA 14.1)
Prior ketoconazole for prostate cancer
Item
Prior ketoconazole for prostate cancer
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0022625 (UMLS CUI 2011AA)
387216007 (SNOMED CT 2011_0131)
MTHU002299 (LOINC Version 232)
C0600139 (UMLS CUI 2011AA)
254900004 (SNOMED CT 2011_0131)
10036921 (MedDRA 14.1)
Known brain metastasis or visceral organ metastasis
Item
Known brain metastasis or visceral organ metastasis
boolean
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
C0042779 (UMLS CUI 2011AA)
C0027627 (UMLS CUI 2011AA)
128462008 (SNOMED CT 2011_0131)
10027449 (MedDRA 14.1)
Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
Item
Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
boolean
C2911207 (UMLS CUI 2011AA)
Z79.891 (ICD-10-CM Version 2010)
C1719395 (UMLS CUI 2011AA)
G89.3 (ICD-10-CM Version 2010)
338.3 (ICD-9-CM Version 2011)
C0009214 (UMLS CUI 2011AA)
85990009 (SNOMED CT 2011_0131)
MTHU004289 (LOINC Version 232)
C0033493 (UMLS CUI 2011AA)
117005003 (SNOMED CT 2011_0131)
MTHU001004 (LOINC Version 232)
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