ID

5057

Description

ODM derived from http://clinicaltrials.gov/show/NCT00974311

Link

http://clinicaltrials.gov/show/NCT00974311

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

April 17, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00006094 NCT00974311 Castration-Resistant 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
Progressive prostate cancer
Description

Progressive prostate cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C0205329
SNOMED CT 2011_0131
255314001
UMLS CUI 2011AA
C0600139
SNOMED CT 2011_0131
254900004
MedDRA 14.1
10036921
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
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
One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
Description

One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel

Data type

boolean

Alias
UMLS CUI 2011AA
C1514457
UMLS CUI 2011AA
C0699967
SNOMED CT 2011_0131
386918005
ECOG performance status 0-2
Description

ECOG performance status 0-2

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
Adequate bone marrow, hepatic, and renal function
Description

Adequate bone marrow, hepatic, and renal function

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0542341
SNOMED CT 2011_0131
246464006
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
Able to swallow the study drug and comply with study requirements
Description

Able to swallow the study drug and comply with study requirements

Data type

boolean

Alias
UMLS CUI 2011AA
C0566356
SNOMED CT 2011_0131
288936000
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514873
Informed Consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Metastases in the brain or active epidural disease
Description

Metastases in the brain or active epidural disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
CL337434
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Another malignancy within the previous 5 years
Description

Another malignancy within the previous 5 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Clinically significant cardiovascular disease
Description

Clinically significant cardiovascular disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
GI disorder affecting absorption
Description

GI disorder affecting absorption

Data type

boolean

Alias
UMLS CUI 2011AA
C0017178
SNOMED CT 2011_0131
119292006
MedDRA 14.1
10017944
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0000854
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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)
Progressive prostate cancer
Item
Progressive prostate cancer
boolean
C0205329 (UMLS CUI 2011AA)
255314001 (SNOMED CT 2011_0131)
C0600139 (UMLS CUI 2011AA)
254900004 (SNOMED CT 2011_0131)
10036921 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
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)
One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
Item
One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
boolean
C1514457 (UMLS CUI 2011AA)
C0699967 (UMLS CUI 2011AA)
386918005 (SNOMED CT 2011_0131)
ECOG performance status 0-2
Item
ECOG performance status 0-2
boolean
C1520224 (UMLS CUI 2011AA)
Adequate bone marrow, hepatic, and renal function
Item
Adequate bone marrow, hepatic, and renal function
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
Able to swallow the study drug and comply with study requirements
Item
Able to swallow the study drug and comply with study requirements
boolean
C0566356 (UMLS CUI 2011AA)
288936000 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
Informed consent
Item
Informed Consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Metastases in the brain or active epidural disease
Item
Metastases in the brain or active epidural disease
boolean
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
CL337434 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Another malignancy within the previous 5 years
Item
Another malignancy within the previous 5 years
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Clinically significant cardiovascular disease
Item
Clinically significant cardiovascular disease
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
GI disorder affecting absorption
Item
GI disorder affecting absorption
boolean
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0000854 (UMLS CUI 2011AA)
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