ID

4500

Descrição

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

Link

http://clinicaltrials.gov/show/NCT00642941

Palavras-chave

Versões (1)
  1. 09/12/2013 09/12/2013 - Martin Dugas
Transferido a

9 de dezembro de 2013

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NCT00642941 Sarcoma

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descrição

Inclusion Criteria

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

age at least 2 Years

Tipo de dados

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.
Descrição

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.

Tipo de dados

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
Descrição

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
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

history of solid organ transplant

Tipo de dados

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.
Descrição

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

Tipo de dados

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 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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