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)
Patients with metastatic papillary renal cell carcinoma, type I or II
Item
Patients with metastatic papillary renal cell carcinoma, type I or II
boolean
C0036525 (UMLS CUI 2011AA)
77879006 (SNOMED CT 2011_0131)
10027474 (MedDRA 14.1)
C1336839 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1336840 (UMLS CUI 2011AA)
Patients with at least one measurable lesion
Item
Patients with at least one measurable lesion
boolean
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1513040 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
Patients with an ECOG Performance Status <=1
Item
ECOG performance status finding <= 1
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Adequate bone marrow function
Item
Adequate bone marrow 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)
Adequate liver function
Item
Adequate liver function
boolean
C1848676 (UMLS CUI 2011AA)
Adequate renal function
Item
Adequate renal function
boolean
C0232805 (UMLS CUI 2011AA)
Adequate lipid profile
Item
Adequate lipid profile
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0023779 (UMLS CUI 2011AA)
70106000 (SNOMED CT 2011_0131)
MTHU003688 (LOINC Version 232)
C2003903 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patients who had radiation therapy within 28 days prior to start of study.
Item
Patients who had radiation therapy within 28 days prior to start of study.
boolean
C0034619 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Patients who have received prior systemic treatment for their metastatic RCC.
Item
Patients who have received prior systemic treatment for their metastatic RCC.
boolean
C1514756 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0278678 (UMLS CUI 2011AA)
10050513 (MedDRA 14.1)
Patients who received prior therapy with VEGF pathway inhibitor.
Item
Patients who received prior therapy with VEGF pathway inhibitor.
boolean
C1514756 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C1171892 (UMLS CUI 2011AA)
417324009 (SNOMED CT 2011_0131)
MTHU016264 (LOINC Version 232)
C1706062 (UMLS CUI 2011AA)
C0243077 (UMLS CUI 2011AA)
Patients who have previously received systemic mTOR inhibitors.
Item
Patients who have previously received systemic mTOR inhibitors.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C1515672 (UMLS CUI 2011AA)
Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
Item
Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
boolean
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)
C0541315 (UMLS CUI 2011AA)
428698007 (SNOMED CT 2011_0131)
MTHU026817 (LOINC Version 232)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0072980 (UMLS CUI 2011AA)
387014003 (SNOMED CT 2011_0131)
MTHU013897 (LOINC Version 232)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Patients with uncontrolled central nervous system (CNS) metastases.
Item
Patients with uncontrolled central nervous system (CNS) metastases.
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0279130 (UMLS CUI 2011AA)
261731003 (SNOMED CT 2011_0131)
Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
Item
Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
boolean
C1514756 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
Patients with a known history of HIV seropositivity.
Item
Patients with a known history of HIV seropositivity.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0521143 (UMLS CUI 2011AA)
4879001 (SNOMED CT 2011_0131)
Patients with autoimmune hepatitis.
Item
Autoimmune Hepatitis
boolean
C0241910 (UMLS CUI 2011AA)
408335007 (SNOMED CT 2011_0131)
10003827 (MedDRA 14.1)
K75.4 (ICD-10-CM Version 2010)
571.42 (ICD-9-CM Version 2011)
Patients with an active, bleeding diathesis.
Item
Patients with an active, bleeding diathesis.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1458140 (UMLS CUI 2011AA)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
Item
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix.
Item
Patients who have a history of another primary malignancy and off treatment ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1306459 (UMLS CUI 2011AA)
372087000 (SNOMED CT 2011_0131)
C1518544 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
Item
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
Item
Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Patients unwilling to or unable to comply with the protocol.
Item
Patients unwilling to or unable to comply with the protocol.
boolean
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)

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