Eligibility NCT00655252 Metastatic Renal Cell Cancer
ODM derived from http://clinicaltrials.gov/show/NCT00655252

Eligibility

  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 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)