ID

42673

Description

ODM derived from http://clinicaltrials.gov/show/NCT01212991

Link

http://clinicaltrials.gov/show/NCT01212991

Keywords

Versions (2)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00005405 NCT01212991 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
Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
Description

Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0007112
SNOMED CT 2011_0131
399490008
MedDRA 14.1
10001186
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0445128
SNOMED CT 2011_0131
264885008
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1709218
Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
Description

Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy

Data type

boolean

Alias
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C0279492
MedDRA 14.1
10002730
UMLS CUI 2011AA
C1518041
SNOMED CT 2011_0131
108772001
UMLS CUI 2011AA
C0007347
SNOMED CT 2011_0131
275234001
Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease
Description

Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease

Data type

boolean

Alias
UMLS CUI 2011AA
C1335499
UMLS CUI 2011AA
C0279492
MedDRA 14.1
10002730
UMLS CUI 2011AA
C0231175
UMLS CUI 2011AA
C0178415
SNOMED CT 2011_0131
396152005
MedDRA 14.1
10036975
ICD-10-CM Version 2010
R97.2
ICD-9-CM Version 2011
790.93
UMLS CUI 2011AA
C0205329
SNOMED CT 2011_0131
255314001
UMLS CUI 2011AA
C0263978
SNOMED CT 2011_0131
19660004
MedDRA 14.1
10061366
ICD-10-CM Version 2010
M79.9
ICD-9-CM Version 2011
729.90
UMLS CUI 2011AA
C0005940
SNOMED CT 2011_0131
76069003
MedDRA 14.1
10005956
ICD-10-CM Version 2010
M89.9
No prior treatment with cytotoxic chemotherapy
Description

No prior treatment with cytotoxic chemotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0677881
Asymptomatic or mildly symptomatic from prostate cancer
Description

Asymptomatic or mildly symptomatic from prostate cancer

Data type

boolean

Alias
UMLS CUI 2011AA
C0231221
SNOMED CT 2011_0131
84387000
UMLS CUI 2011AA
C2945599
SNOMED CT 2011_0131
255604002
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0600139
SNOMED CT 2011_0131
254900004
MedDRA 14.1
10036921
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
Description

Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C1836348
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0009488
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1548788
UMLS CUI 2011AA
C1516879
Known or suspected brain metastasis or active leptomeningeal disease
Description

Known or suspected brain metastasis or active leptomeningeal disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
CL428853
MedDRA 14.1
10070973
History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
Description

History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
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
CL411789
UMLS CUI 2011AA
C1880198
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
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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)
Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
Item
Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0007112 (UMLS CUI 2011AA)
399490008 (SNOMED CT 2011_0131)
10001186 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0445128 (UMLS CUI 2011AA)
264885008 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1709218 (UMLS CUI 2011AA)
Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
Item
Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
boolean
C0549178 (UMLS CUI 2011AA)
C0279492 (UMLS CUI 2011AA)
10002730 (MedDRA 14.1)
C1518041 (UMLS CUI 2011AA)
108772001 (SNOMED CT 2011_0131)
C0007347 (UMLS CUI 2011AA)
275234001 (SNOMED CT 2011_0131)
Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease
Item
Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease
boolean
C1335499 (UMLS CUI 2011AA)
C0279492 (UMLS CUI 2011AA)
10002730 (MedDRA 14.1)
C0231175 (UMLS CUI 2011AA)
C0178415 (UMLS CUI 2011AA)
396152005 (SNOMED CT 2011_0131)
10036975 (MedDRA 14.1)
R97.2 (ICD-10-CM Version 2010)
790.93 (ICD-9-CM Version 2011)
C0205329 (UMLS CUI 2011AA)
255314001 (SNOMED CT 2011_0131)
C0263978 (UMLS CUI 2011AA)
19660004 (SNOMED CT 2011_0131)
10061366 (MedDRA 14.1)
M79.9 (ICD-10-CM Version 2010)
729.90 (ICD-9-CM Version 2011)
C0005940 (UMLS CUI 2011AA)
76069003 (SNOMED CT 2011_0131)
10005956 (MedDRA 14.1)
M89.9 (ICD-10-CM Version 2010)
No prior treatment with cytotoxic chemotherapy
Item
No prior treatment with cytotoxic chemotherapy
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0677881 (UMLS CUI 2011AA)
Asymptomatic or mildly symptomatic from prostate cancer
Item
Asymptomatic or mildly symptomatic from prostate cancer
boolean
C0231221 (UMLS CUI 2011AA)
84387000 (SNOMED CT 2011_0131)
C2945599 (UMLS CUI 2011AA)
255604002 (SNOMED CT 2011_0131)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0600139 (UMLS CUI 2011AA)
254900004 (SNOMED CT 2011_0131)
10036921 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
Item
Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C1836348 (UMLS CUI 2011AA)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0009488 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1548788 (UMLS CUI 2011AA)
C1516879 (UMLS CUI 2011AA)
Known or suspected brain metastasis or active leptomeningeal disease
Item
Known or suspected brain metastasis or active leptomeningeal disease
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
CL428853 (UMLS CUI 2011AA)
10070973 (MedDRA 14.1)
History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
Item
History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
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)
CL411789 (UMLS CUI 2011AA)
C1880198 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
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