ID

4497

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT00655252

Link

http://clinicaltrials.gov/show/NCT00655252

Palavras-chave

Versões (1)
  1. 09/12/2013 09/12/2013 - Martin Dugas
Transferido a

9 de dezembro de 2013

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NCT00655252 Metastatic Renal Cell Cancer

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Descrição

age at least 18 Years

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
metastatic renal cancer, intolerant of or failed sunitinib and/or sorafenib
Descrição

metastatic renal cancer, intolerant of or failed sunitinib and/or sorafenib

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0919976
MedDRA 14.1
10050018
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1744706
UMLS CUI 2011AA
C0231175
UMLS CUI 2011AA
C1176020
SNOMED CT 2011_0131
421192001
UMLS CUI 2011AA
C1516119
SNOMED CT 2011_0131
422042001
Adequate bone marrow function, liver function, renal function
Descrição

Adequate bone marrow function, liver function, renal function

Tipo de dados

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
Adequate birth control
Descrição

Adequate birth control

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Other protocol-defined inclusion criteria may apply
Descrição

Other protocol-defined inclusion criteria may apply

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
CL425202
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Previously received RAD001 or other mTOR inhibitors, known hypersensitivity to rapamycin, chronic systemic treatment with corticosteroids or immunosuppressive agents (prednisone <= 20 mg/day for adrenal insufficiency OK
Descrição

Previously received RAD001 or other mTOR inhibitors, known hypersensitivity to rapamycin, chronic systemic treatment with corticosteroids or immunosuppressive agents (prednisone <= 20 mg/day for adrenal insufficiency OK

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0541315
SNOMED CT 2011_0131
428698007
LOINC Version 232
MTHU026817
UMLS CUI 2011AA
C1414805
UMLS CUI 2011AA
C0243077
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0072980
SNOMED CT 2011_0131
387014003
LOINC Version 232
MTHU013897
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0032952
SNOMED CT 2011_0131
116602009
LOINC Version 232
MTHU003245
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0001623
SNOMED CT 2011_0131
111563005
MedDRA 14.1
10001367
CTCAE 1105E
E10298
UMLS CUI 2011AA
C1706842
Topical or inhaled steroids OK)
Descrição

Topical or inhaled steroids OK)

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
CL383597
UMLS CUI 2011AA
C0586793
SNOMED CT 2011_0131
170659001
UMLS CUI 2011AA
C1706842
Active bleeding
Descrição

Active bleeding

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0019080
SNOMED CT 2011_0131
50960005
MedDRA 14.1
10055798
ICD-10-CM Version 2010
R58
ICD-9-CM Version 2011
459.0
Uncontrolled angina, CHF, heart attack <= 6 months, uncontrolled diabetes
Descrição

Uncontrolled angina, CHF, heart attack <= 6 months, uncontrolled diabetes

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0002962
SNOMED CT 2011_0131
194828000
MedDRA 14.1
10002383
ICD-10-CM Version 2010
I20
ICD-9-CM Version 2011
413
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
Other protocol-defined exclusion criteria may apply
Descrição

Other protocol-defined exclusion criteria may apply

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
CL425201
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Similar models

Eligibility

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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 renal cancer, intolerant of or failed sunitinib and/or sorafenib
Item
metastatic renal cancer, intolerant of or failed sunitinib and/or sorafenib
boolean
C0919976 (UMLS CUI 2011AA)
10050018 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1744706 (UMLS CUI 2011AA)
C0231175 (UMLS CUI 2011AA)
C1176020 (UMLS CUI 2011AA)
421192001 (SNOMED CT 2011_0131)
C1516119 (UMLS CUI 2011AA)
422042001 (SNOMED CT 2011_0131)
Adequate bone marrow function, liver function, renal function
Item
Adequate bone marrow function, liver function, 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)
Adequate birth control
Item
Adequate birth control
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Other protocol-defined inclusion criteria may apply
Item
Other protocol-defined inclusion criteria may apply
boolean
C2348563 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
CL425202 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Previously received RAD001 or other mTOR inhibitors, known hypersensitivity to rapamycin, chronic systemic treatment with corticosteroids or immunosuppressive agents (prednisone <= 20 mg/day for adrenal insufficiency OK
Item
Previously received RAD001 or other mTOR inhibitors, known hypersensitivity to rapamycin, chronic systemic treatment with corticosteroids or immunosuppressive agents (prednisone <= 20 mg/day for adrenal insufficiency OK
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0541315 (UMLS CUI 2011AA)
428698007 (SNOMED CT 2011_0131)
MTHU026817 (LOINC Version 232)
C1414805 (UMLS CUI 2011AA)
C0243077 (UMLS CUI 2011AA)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0072980 (UMLS CUI 2011AA)
387014003 (SNOMED CT 2011_0131)
MTHU013897 (LOINC Version 232)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0001623 (UMLS CUI 2011AA)
111563005 (SNOMED CT 2011_0131)
10001367 (MedDRA 14.1)
E10298 (CTCAE 1105E)
C1706842 (UMLS CUI 2011AA)
Topical or inhaled steroids OK)
Item
Topical or inhaled steroids OK)
boolean
CL383597 (UMLS CUI 2011AA)
C0586793 (UMLS CUI 2011AA)
170659001 (SNOMED CT 2011_0131)
C1706842 (UMLS CUI 2011AA)
Active bleeding
Item
Active bleeding
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
Uncontrolled angina, CHF, heart attack <= 6 months, uncontrolled diabetes
Item
Uncontrolled angina, CHF, heart attack <= 6 months, uncontrolled diabetes
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
Other protocol-defined exclusion criteria may apply
Item
Other protocol-defined exclusion criteria may apply
boolean
C2348563 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
CL425201 (UMLS CUI 2011AA)
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