0 Ratings
ID

4500

Description

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

Link

http://clinicaltrials.gov/show/NCT00642941

Keywords

Versions (1)
  1. 12/9/13 12/9/13 - Martin Dugas
Uploaded on

December 9, 2013

DOI

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Creative Commons BY 4.0
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    Eligibility NCT00642941 Sarcoma

    German English

    Eligibility

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425202
    age at least 2 Years
    Description

    age at least 2 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    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.
    Description

    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.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205329
    SNOMED CT 2011_0131
    255314001
    UMLS CUI 2011AA
    C0205269
    SNOMED CT 2011_0131
    20646008
    UMLS CUI 2011AA
    C0553580
    SNOMED CT 2011_0131
    76909002
    MedDRA 14.1
    10015560
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0278590
    MedDRA 14.1
    10015564
    UMLS CUI 2011AA
    C0278779
    MedDRA 14.1
    10031296
    UMLS CUI 2011AA
    C0205269
    SNOMED CT 2011_0131
    20646008
    UMLS CUI 2011AA
    C0029463
    SNOMED CT 2011_0131
    21708004
    MedDRA 14.1
    10031291
    UMLS CUI 2011AA
    C0855072
    MedDRA 14.1
    10042867
    UMLS CUI 2011AA
    C0205269
    SNOMED CT 2011_0131
    20646008
    UMLS CUI 2011AA
    C0039101
    SNOMED CT 2011_0131
    63211008
    MedDRA 14.1
    10042863
    UMLS CUI 2011AA
    C0855069
    MedDRA 14.1
    10039027
    UMLS CUI 2011AA
    C0205269
    SNOMED CT 2011_0131
    20646008
    UMLS CUI 2011AA
    C0035412
    SNOMED CT 2011_0131
    302847003
    MedDRA 14.1
    10039022
    UMLS CUI 2011AA
    C1261473
    SNOMED CT 2011_0131
    424413001
    MedDRA 14.1
    10039491
    UMLS CUI 2011AA
    C0332282
    SNOMED CT 2011_0131
    255260001
    UMLS CUI 2011AA
    C0449560
    SNOMED CT 2011_0131
    260837004
    UMLS CUI 2011AA
    C0206657
    SNOMED CT 2011_0131
    404056007
    MedDRA 14.1
    10001882
    UMLS CUI 2011AA
    C0281508
    SNOMED CT 2011_0131
    128735004
    MedDRA 14.1
    10064581
    UMLS CUI 2011AA
    C1275278
    SNOMED CT 2011_0131
    404079008
    MedDRA 14.1
    10015838
    UMLS CUI 2011AA
    C0206651
    SNOMED CT 2011_0131
    271944004
    MedDRA 14.1
    10065865
    UMLS CUI 2011AA
    C0206634
    SNOMED CT 2011_0131
    404069006
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    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
    Description

    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

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205210
    SNOMED CT 2011_0131
    58147004
    UMLS CUI 2011AA
    C0750502
    SNOMED CT 2011_0131
    386134007
    UMLS CUI 2011AA
    CL414700
    UMLS CUI 2011AA
    C0442893
    SNOMED CT 2011_0131
    56019007, 264578000
    UMLS CUI 2011AA
    C0221099
    SNOMED CT 2011_0131
    260379002
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C0085732
    SNOMED CT 2011_0131
    371150009
    UMLS CUI 2011AA
    C0013220
    SNOMED CT 2011_0131
    228432001
    MedDRA 14.1
    10052804
    UMLS CUI 2011AA
    C0013230
    UMLS CUI 2011AA
    C0521102
    SNOMED CT 2011_0131
    78235001
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C2700391
    UMLS CUI 2011AA
    C1274040
    SNOMED CT 2011_0131
    79409006
    known hypersensitivity to any of the components of R1507 or prior hypersensitivity reactions to monoclonal antibodies
    Description

    known hypersensitivity to any of the components of R1507 or prior hypersensitivity reactions to monoclonal antibodies

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205309
    SNOMED CT 2011_0131
    36692007
    UMLS CUI 2011AA
    C0020517
    SNOMED CT 2011_0131
    418634005
    ICD-10-CM Version 2010
    T78.40
    UMLS CUI 2011AA
    C1705248
    UMLS CUI 2011AA
    C2346815
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1527304
    SNOMED CT 2011_0131
    421668005
    MedDRA 14.1
    10001718
    ICD-10-CM Version 2010
    T78.40
    UMLS CUI 2011AA
    C0003250
    SNOMED CT 2011_0131
    49616005
    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
    Description

    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

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C2827774
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    C1517741
    UMLS CUI 2011AA
    C2825407
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    UMLS CUI 2011AA
    C0205191
    SNOMED CT 2011_0131
    90734009
    UMLS CUI 2011AA
    C0205464
    SNOMED CT 2011_0131
    56183000
    UMLS CUI 2011AA
    C0178602
    SNOMED CT 2011_0131
    260911001
    UMLS CUI 2011AA
    C0001617
    SNOMED CT 2011_0131
    79440004
    UMLS CUI 2011AA
    C0021081
    SNOMED CT 2011_0131
    372823004, 69431002
    UMLS CUI 2011AA
    C0013227
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C1879547
    UMLS CUI 2011AA
    C0521102
    SNOMED CT 2011_0131
    78235001
    UMLS CUI 2011AA
    C0205464
    SNOMED CT 2011_0131
    56183000
    UMLS CUI 2011AA
    C0441655
    SNOMED CT 2011_0131
    257733005
    LOINC Version 232
    MTHU002837
    ICD-9-CM Version 2011
    E001-E030.9
    UMLS CUI 2011AA
    C2346815
    current or prior therapy with IGF inhibitor (monoclonal or specific kinase inhibitor)
    Description

    current or prior therapy with IGF inhibitor (monoclonal or specific kinase inhibitor)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C2827774
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    C0037657
    SNOMED CT 2011_0131
    70825004
    LOINC Version 232
    MTHU012330
    UMLS CUI 2011AA
    C0243077
    UMLS CUI 2011AA
    C0003250
    SNOMED CT 2011_0131
    49616005
    UMLS CUI 2011AA
    C0243077
    UMLS CUI 2011AA
    C1552740
    HL7 V3 2006_05
    INSTANCE
    UMLS CUI 2011AA
    C1171350
    history of solid organ transplant
    Description

    history of solid organ transplant

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0730400
    SNOMED CT 2011_0131
    313039003
    other malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer.
    Description

    other malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0006826
    SNOMED CT 2011_0131
    363346000
    MedDRA 14.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0205156
    SNOMED CT 2011_0131
    9130008
    UMLS CUI 2011AA
    C0205451
    SNOMED CT 2011_0131
    34001005
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    UMLS CUI 2011AA
    CL411789
    UMLS CUI 2011AA
    CL104876
    UMLS CUI 2011AA
    C0699893
    MedDRA 14.1
    10040810
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    Similar models

    Eligibility

    1 forms
    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)
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