ID

5126

Descripción

ODM derived from http://clinicaltrials.gov/show/NCT01307397

Link

http://clinicaltrials.gov/show/NCT01307397

Palabras clave

  1. 21/3/13 21/3/13 - Martin Dugas
  2. 19/4/14 19/4/14 - Julian Varghese
Subido en

19 de abril de 2014

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0

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    Eligibility DRKS00003620 NCT01307397 Malignant Melanoma

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Descripción

    Einschlusskriterien

    Alter mindestens 18 Jahre
    Descripción

    age at least 18 Years

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Erwachsener, erwachsen
    Descripción

    Adult patients, >/= 18 years of age

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0001675
    SNOMED CT 2011_0131
    133936004
    Histologically confirmed metastatic melanoma with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test
    Descripción

    Histologically confirmed metastatic melanoma with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0205462
    SNOMED CT 2011_0131
    67151002
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C0860594
    SNOMED CT 2011_0131
    443493003
    MedDRA 14.1
    10027480
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C2698302
    UMLS CUI 2011AA
    C0521095
    SNOMED CT 2011_0131
    436000
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1511021
    UMLS CUI 2011AA
    C0392366
    SNOMED CT 2011_0131
    272393004
    Disease Progression after at least one prior systemic treatment for metastatic melanoma
    Descripción

    Disease Progression after at least one prior systemic treatment for metastatic melanoma

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C1947901
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1515119
    UMLS CUI 2011AA
    C0860594
    SNOMED CT 2011_0131
    443493003
    MedDRA 14.1
    10027480
    Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    Descripción

    Eastern Cooperative Oncology Group (ECOG) performance status 0-2

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C1520224
    Adequate hematologic, renal and liver function
    Descripción

    Adequate hematologic, renal and liver function

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0205411
    SNOMED CT 2011_0131
    88323005
    UMLS CUI 2011AA
    C0221130
    SNOMED CT 2011_0131
    86084001
    UMLS CUI 2011AA
    C0232804
    SNOMED CT 2011_0131
    11953005
    UMLS CUI 2011AA
    C0232741
    SNOMED CT 2011_0131
    79036002
    Ausschlusskriterien
    Descripción

    Ausschlusskriterien

    Evidence of symptomatic CNS lesions
    Descripción

    Evidence of symptomatic CNS lesions

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0332120
    SNOMED CT 2011_0131
    18669006
    UMLS CUI 2011AA
    C0231220
    SNOMED CT 2011_0131
    264931009
    UMLS CUI 2011AA
    C0742468
    MedDRA 14.1
    10051290
    Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
    Descripción

    Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    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
    C0025202
    SNOMED CT 2011_0131
    2092003
    MedDRA 14.1
    10025650
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C2587213
    SNOMED CT 2011_0131
    31509003
    UMLS CUI 2011AA
    C0007117
    SNOMED CT 2011_0131
    1338007, 254701007
    MedDRA 14.1
    10004146
    UMLS CUI 2011AA
    C0553723
    SNOMED CT 2011_0131
    254651007
    MedDRA 14.1
    10041834
    UMLS CUI 2011AA
    C0851140
    SNOMED CT 2011_0131
    92564006
    MedDRA 14.1
    10061809
    ICD-10-CM Version 2010
    D06.9
    ICD-9-CM Version 2011
    233.1
    Concurrent administration of any anti-cancer therapies other than those administered in the study
    Descripción

    Concurrent administration of any anti-cancer therapies other than those administered in the study

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0205420
    SNOMED CT 2011_0131
    68405009
    UMLS CUI 2011AA
    C0920425
    UMLS CUI 2011AA
    C1521801
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
    Descripción

    Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0205210
    SNOMED CT 2011_0131
    58147004
    UMLS CUI 2011AA
    C0750502
    SNOMED CT 2011_0131
    386134007
    UMLS CUI 2011AA
    C0007222
    SNOMED CT 2011_0131
    105980002
    MedDRA 14.1
    10007649
    ICD-9-CM Version 2011
    429.2
    UMLS CUI 2011AA
    C1320716
    SNOMED CT 2011_0131
    405617006
    Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
    Descripción

    Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption

    Tipo de datos

    boolean

    Alias
    UMLS CUI 2011AA
    C0205269
    SNOMED CT 2011_0131
    20646008
    UMLS CUI 2011AA
    C0027497
    SNOMED CT 2011_0131
    422587007
    MedDRA 14.1
    10028813
    LOINC Version 232
    MTHU013524
    ICD-10-CM Version 2010
    R11.0
    CTCAE 1105E
    E10878
    UMLS CUI 2011AA
    C0042963
    SNOMED CT 2011_0131
    249497008
    MedDRA 14.1
    10047700
    LOINC Version 232
    MTHU013530
    ICD-10-CM Version 2010
    R11.1
    CTCAE 1105E
    E11068
    UMLS CUI 2011AA
    C0205101
    SNOMED CT 2011_0131
    261074009
    UMLS CUI 2011AA
    C0005423
    SNOMED CT 2011_0131
    34707002
    LOINC Version 232
    MTHU024380
    UMLS CUI 2011AA
    C0542331
    SNOMED CT 2011_0131
    257351008
    UMLS CUI 2011AA
    C0741614
    MedDRA 14.1
    10067878

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Einschlusskriterien
    age at least 18 Years
    Item
    Alter mindestens 18 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Adult patients, >/= 18 years of age
    Item
    Erwachsener, erwachsen
    boolean
    C0001675 (UMLS CUI 2011AA)
    133936004 (SNOMED CT 2011_0131)
    Histologically confirmed metastatic melanoma with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test
    Item
    Histologically confirmed metastatic melanoma with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test
    boolean
    C0205462 (UMLS CUI 2011AA)
    67151002 (SNOMED CT 2011_0131)
    C0750484 (UMLS CUI 2011AA)
    C0860594 (UMLS CUI 2011AA)
    443493003 (SNOMED CT 2011_0131)
    10027480 (MedDRA 14.1)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C2698302 (UMLS CUI 2011AA)
    C0521095 (UMLS CUI 2011AA)
    436000 (SNOMED CT 2011_0131)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1511021 (UMLS CUI 2011AA)
    C0392366 (UMLS CUI 2011AA)
    272393004 (SNOMED CT 2011_0131)
    Disease Progression after at least one prior systemic treatment for metastatic melanoma
    Item
    Disease Progression after at least one prior systemic treatment for metastatic melanoma
    boolean
    C1947901 (UMLS CUI 2011AA)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1515119 (UMLS CUI 2011AA)
    C0860594 (UMLS CUI 2011AA)
    443493003 (SNOMED CT 2011_0131)
    10027480 (MedDRA 14.1)
    Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    Item
    Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    boolean
    C1520224 (UMLS CUI 2011AA)
    Adequate hematologic, renal and liver function
    Item
    Adequate hematologic, renal and liver function
    boolean
    C0205411 (UMLS CUI 2011AA)
    88323005 (SNOMED CT 2011_0131)
    C0221130 (UMLS CUI 2011AA)
    86084001 (SNOMED CT 2011_0131)
    C0232804 (UMLS CUI 2011AA)
    11953005 (SNOMED CT 2011_0131)
    C0232741 (UMLS CUI 2011AA)
    79036002 (SNOMED CT 2011_0131)
    Item Group
    Ausschlusskriterien
    Evidence of symptomatic CNS lesions
    Item
    Evidence of symptomatic CNS lesions
    boolean
    C0332120 (UMLS CUI 2011AA)
    18669006 (SNOMED CT 2011_0131)
    C0231220 (UMLS CUI 2011AA)
    264931009 (SNOMED CT 2011_0131)
    C0742468 (UMLS CUI 2011AA)
    10051290 (MedDRA 14.1)
    Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
    Item
    Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
    boolean
    C0332152 (UMLS CUI 2011AA)
    288556008 (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)
    C0025202 (UMLS CUI 2011AA)
    2092003 (SNOMED CT 2011_0131)
    10025650 (MedDRA 14.1)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C2587213 (UMLS CUI 2011AA)
    31509003 (SNOMED CT 2011_0131)
    C0007117 (UMLS CUI 2011AA)
    1338007, 254701007 (SNOMED CT 2011_0131)
    10004146 (MedDRA 14.1)
    C0553723 (UMLS CUI 2011AA)
    254651007 (SNOMED CT 2011_0131)
    10041834 (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)
    Concurrent administration of any anti-cancer therapies other than those administered in the study
    Item
    Concurrent administration of any anti-cancer therapies other than those administered in the study
    boolean
    C0205420 (UMLS CUI 2011AA)
    68405009 (SNOMED CT 2011_0131)
    C0920425 (UMLS CUI 2011AA)
    C1521801 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
    Item
    Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
    boolean
    C0205210 (UMLS CUI 2011AA)
    58147004 (SNOMED CT 2011_0131)
    C0750502 (UMLS CUI 2011AA)
    386134007 (SNOMED CT 2011_0131)
    C0007222 (UMLS CUI 2011AA)
    105980002 (SNOMED CT 2011_0131)
    10007649 (MedDRA 14.1)
    429.2 (ICD-9-CM Version 2011)
    C1320716 (UMLS CUI 2011AA)
    405617006 (SNOMED CT 2011_0131)
    Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
    Item
    Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
    boolean
    C0205269 (UMLS CUI 2011AA)
    20646008 (SNOMED CT 2011_0131)
    C0027497 (UMLS CUI 2011AA)
    422587007 (SNOMED CT 2011_0131)
    10028813 (MedDRA 14.1)
    MTHU013524 (LOINC Version 232)
    R11.0 (ICD-10-CM Version 2010)
    E10878 (CTCAE 1105E)
    C0042963 (UMLS CUI 2011AA)
    249497008 (SNOMED CT 2011_0131)
    10047700 (MedDRA 14.1)
    MTHU013530 (LOINC Version 232)
    R11.1 (ICD-10-CM Version 2010)
    E11068 (CTCAE 1105E)
    C0205101 (UMLS CUI 2011AA)
    261074009 (SNOMED CT 2011_0131)
    C0005423 (UMLS CUI 2011AA)
    34707002 (SNOMED CT 2011_0131)
    MTHU024380 (LOINC Version 232)
    C0542331 (UMLS CUI 2011AA)
    257351008 (SNOMED CT 2011_0131)
    C0741614 (UMLS CUI 2011AA)
    10067878 (MedDRA 14.1)

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