Eligibility DRKS00003621 NCT00518895 Melanoma

ODM derived from http://clinicaltrials.gov/show/NCT00518895

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Eligibility

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  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Inclusion Criteria
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 diagnosis of melanoma
Item
Histologically confirmed diagnosis of melanoma
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0025202 (UMLS CUI 2011AA)
2092003 (SNOMED CT 2011_0131)
10025650 (MedDRA 14.1)
Progressive disease that is not surgically resectable, or metastatic Stage IV
Item
Progressive disease that is not surgically resectable, or metastatic Stage IV
boolean
C1335499 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1514888 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C0441970 (UMLS CUI 2011AA)
258299008 (SNOMED CT 2011_0131)
Low-normal LDH, defined as <= 0.8 times the upper limit of normal
Item
Low-normal LDH, defined as <= 0.8 times the upper limit of normal
boolean
C0205251 (UMLS CUI 2011AA)
62482003 (SNOMED CT 2011_0131)
C0205307 (UMLS CUI 2011AA)
17621005 (SNOMED CT 2011_0131)
C0022917 (UMLS CUI 2011AA)
259319003 (SNOMED CT 2011_0131)
MTHU002348 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
No prior chemotherapy
Item
No prior chemotherapy
boolean
C1518422 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
Measurable disease
Item
Measurable Disease
boolean
C1513041 (UMLS CUI 2011AA)
ECOG performance status <= 1
Item
ECOG performance status finding <= 1
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy
Item
At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy
boolean
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0241311 (UMLS CUI 2011AA)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C2004454 (UMLS CUI 2011AA)
CL330043 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C0079189 (UMLS CUI 2011AA)
75777003 (SNOMED CT 2011_0131)
MTHU018469 (LOINC Version 232)
C0005527 (UMLS CUI 2011AA)
C0042209 (UMLS CUI 2011AA)
Prior immunotherapy allowed
Item
Prior immunotherapy allowed
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
C1524004 (UMLS CUI 2011AA)
Adequate organ function
Item
Adequate organ function
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0678852 (UMLS CUI 2011AA)
Exclusion Criteria
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment
Item
Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0677881 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C1571591 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0935954 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Primary ocular or mucosal melanoma
Item
Primary ocular or mucosal melanoma
boolean
CL414904 (UMLS CUI 2011AA)
C0558356 (UMLS CUI 2011AA)
274087000 (SNOMED CT 2011_0131)
10030052 (MedDRA 14.1)
CL388343 (UMLS CUI 2011AA)
Bone-only metastatic disease
Item
Metastatic Malignant Neoplasm to the Bone
boolean
C0153690 (UMLS CUI 2011AA)
94222008 (SNOMED CT 2011_0131)
10055101 (MedDRA 14.1)
C79.51 (ICD-10-CM Version 2010)
198.5 (ICD-9-CM Version 2011)
History or presence of brain metastasis or leptomeningeal disease
Item
History or presence of brain metastasis or leptomeningeal disease
boolean
C0220650 (UMLS CUI 2011AA)
Significant medical disease other than cancer
Item
Significant medical disease other than cancer
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Organ allograft
Item
Organ allograft
boolean
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C0522536 (UMLS CUI 2011AA)
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