Eligibility NCT00642941 Sarcoma
ODM derived from http://clinicaltrials.gov/show/NCT00642941

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 2 Years
Item
age at least 2 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
progressive, recurrent or refractory Ewing's sarcoma, or recurrent or refractory osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas of the following sub-types: alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma and myxoid liposarcoma.
Item
progressive, recurrent or refractory Ewing's sarcoma, or recurrent or refractory osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas of the following sub-types: alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma and myxoid liposarcoma.
boolean
C0205329 (UMLS CUI 2011AA)
255314001 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0553580 (UMLS CUI 2011AA)
76909002 (SNOMED CT 2011_0131)
10015560 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0278590 (UMLS CUI 2011AA)
10015564 (MedDRA 14.1)
C0278779 (UMLS CUI 2011AA)
10031296 (MedDRA 14.1)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0029463 (UMLS CUI 2011AA)
21708004 (SNOMED CT 2011_0131)
10031291 (MedDRA 14.1)
C0855072 (UMLS CUI 2011AA)
10042867 (MedDRA 14.1)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0039101 (UMLS CUI 2011AA)
63211008 (SNOMED CT 2011_0131)
10042863 (MedDRA 14.1)
C0855069 (UMLS CUI 2011AA)
10039027 (MedDRA 14.1)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0035412 (UMLS CUI 2011AA)
302847003 (SNOMED CT 2011_0131)
10039022 (MedDRA 14.1)
C1261473 (UMLS CUI 2011AA)
424413001 (SNOMED CT 2011_0131)
10039491 (MedDRA 14.1)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0449560 (UMLS CUI 2011AA)
260837004 (SNOMED CT 2011_0131)
C0206657 (UMLS CUI 2011AA)
404056007 (SNOMED CT 2011_0131)
10001882 (MedDRA 14.1)
C0281508 (UMLS CUI 2011AA)
128735004 (SNOMED CT 2011_0131)
10064581 (MedDRA 14.1)
C1275278 (UMLS CUI 2011AA)
404079008 (SNOMED CT 2011_0131)
10015838 (MedDRA 14.1)
C0206651 (UMLS CUI 2011AA)
271944004 (SNOMED CT 2011_0131)
10065865 (MedDRA 14.1)
C0206634 (UMLS CUI 2011AA)
404069006 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
clinically significant unrelated systemic illness which would compromise the patient's ability to tolerate the investigational agent, or interfere with the study procedures or results
Item
clinically significant unrelated systemic illness which would compromise the patient's ability to tolerate the investigational agent, or interfere with the study procedures or results
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
CL414700 (UMLS CUI 2011AA)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0013220 (UMLS CUI 2011AA)
228432001 (SNOMED CT 2011_0131)
10052804 (MedDRA 14.1)
C0013230 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C2700391 (UMLS CUI 2011AA)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
known hypersensitivity to any of the components of R1507 or prior hypersensitivity reactions to monoclonal antibodies
Item
known hypersensitivity to any of the components of R1507 or prior hypersensitivity reactions to monoclonal antibodies
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)
C1705248 (UMLS CUI 2011AA)
C2346815 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1527304 (UMLS CUI 2011AA)
421668005 (SNOMED CT 2011_0131)
10001718 (MedDRA 14.1)
T78.40 (ICD-10-CM Version 2010)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
current or previous treatment (within last 6 months) with chronic pharmacological doses of corticosteroids, immunosuppressive agents or medications that inactivate or may interfere with the pharmacological activity of R1507
Item
current or previous treatment (within last 6 months) with chronic pharmacological doses of corticosteroids, immunosuppressive agents or medications that inactivate or may interfere with the pharmacological activity of R1507
boolean
C2827774 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0205464 (UMLS CUI 2011AA)
56183000 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1879547 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0205464 (UMLS CUI 2011AA)
56183000 (SNOMED CT 2011_0131)
C0441655 (UMLS CUI 2011AA)
257733005 (SNOMED CT 2011_0131)
MTHU002837 (LOINC Version 232)
E001-E030.9 (ICD-9-CM Version 2011)
C2346815 (UMLS CUI 2011AA)
current or prior therapy with IGF inhibitor (monoclonal or specific kinase inhibitor)
Item
current or prior therapy with IGF inhibitor (monoclonal or specific kinase inhibitor)
boolean
C2827774 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C0037657 (UMLS CUI 2011AA)
70825004 (SNOMED CT 2011_0131)
MTHU012330 (LOINC Version 232)
C0243077 (UMLS CUI 2011AA)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
C0243077 (UMLS CUI 2011AA)
C1552740 (UMLS CUI 2011AA)
INSTANCE (HL7 V3 2006_05)
C1171350 (UMLS CUI 2011AA)
history of solid organ transplant
Item
history of solid organ transplant
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0730400 (UMLS CUI 2011AA)
313039003 (SNOMED CT 2011_0131)
other malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer.
Item
other malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
CL411789 (UMLS CUI 2011AA)
CL104876 (UMLS CUI 2011AA)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)