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)
Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
Item
Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0854698 (UMLS CUI 2011AA)
10025671 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
ECOG performance status of <=2
Item
ECOG performance status finding <=2
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Measurable disease according to modified RECIST
Item
Measurable disease according to modified RECIST
boolean
C1513041 (UMLS CUI 2011AA)
Life expectancy >12 weeks
Item
Life expectancy >12 weeks
boolean
C0023671 (UMLS CUI 2011AA)
LDH <= 2.0 x ULN
Item
LDH <= 2.0 x ULN
boolean
C0022917 (UMLS CUI 2011AA)
259319003 (SNOMED CT 2011_0131)
MTHU002348 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Clinical lab values within protocol parameters.
Item
Clinical lab values within protocol parameters.
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
C2699426 (UMLS CUI 2011AA)
C2348563 (UMLS CUI 2011AA)
C0549193 (UMLS CUI 2011AA)
246446004 (SNOMED CT 2011_0131)
At least 18 years old and able and willing to provide informed consent to participate
Item
At least 18 years old and able and willing to provide informed consent to participate
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0021430 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Previous cytotoxic chemotherapy treatment for melanoma
Item
Previous cytotoxic chemotherapy treatment for melanoma
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0677881 (UMLS CUI 2011AA)
C0025202 (UMLS CUI 2011AA)
2092003 (SNOMED CT 2011_0131)
10025650 (MedDRA 14.1)
Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.
Item
Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.
boolean
C1514756 (UMLS CUI 2011AA)
CL031856 (UMLS CUI 2011AA)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
C1171350 (UMLS CUI 2011AA)
C0005527 (UMLS CUI 2011AA)
C0042209 (UMLS CUI 2011AA)
C0949266 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0025202 (UMLS CUI 2011AA)
2092003 (SNOMED CT 2011_0131)
10025650 (MedDRA 14.1)
Presence of brain metastases
Item
Presence of brain metastases
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
Presence or history (<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
Item
Presence or history (<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0085183 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
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 subjects who are pregnant or nursing
Item
Female subjects who are pregnant or nursing
boolean
C0086287 (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)

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