ID

4919

Descripción

ODM derived from http://clinicaltrials.gov/show/NCT00522834

Link

http://clinicaltrials.gov/show/NCT00522834

Palabras clave

  1. 10/12/13 10/12/13 - Martin Dugas
  2. 14/4/14 14/4/14 - Julian Varghese
  3. 20/9/21 20/9/21 -
Subido en

14 de abril de 2014

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility NCT00522834 Melanoma

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Descripción

age at least 18 Years

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
Descripción

Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0854698
MedDRA 14.1
10025671
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
ECOG performance status finding <=2
Descripción

ECOG performance status of <=2

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
Measurable disease according to modified RECIST
Descripción

Measurable disease according to modified RECIST

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1513041
Life expectancy >12 weeks
Descripción

Life expectancy >12 weeks

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0023671
LDH <= 2.0 x ULN
Descripción

LDH <= 2.0 x ULN

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0022917
SNOMED CT 2011_0131
259319003
LOINC Version 232
MTHU002348
UMLS CUI 2011AA
C1519815
Clinical lab values within protocol parameters.
Descripción

Clinical lab values within protocol parameters.

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C1522609
UMLS CUI 2011AA
C2699426
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C0549193
SNOMED CT 2011_0131
246446004
At least 18 years old and able and willing to provide informed consent to participate
Descripción

At least 18 years old and able and willing to provide informed consent to participate

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0021430
SNOMED CT 2011_0131
371150009
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Previous cytotoxic chemotherapy treatment for melanoma
Descripción

Previous cytotoxic chemotherapy treatment for melanoma

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0677881
UMLS CUI 2011AA
C0025202
SNOMED CT 2011_0131
2092003
MedDRA 14.1
10025650
Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.
Descripción

Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C0021083
SNOMED CT 2011_0131
146638005
UMLS CUI 2011AA
C1171350
UMLS CUI 2011AA
C0005527
UMLS CUI 2011AA
C0042209
UMLS CUI 2011AA
C0949266
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0025202
SNOMED CT 2011_0131
2092003
MedDRA 14.1
10025650
Presence of brain metastases
Descripción

Presence of brain metastases

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
Presence or history (<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
Descripción

Presence or history (<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0085183
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
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
Female subjects who are pregnant or nursing
Descripción

Female subjects who are pregnant or nursing

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
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 metastatic (Stage IV) melanoma of cutaneous origin
Item
Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0854698 (UMLS CUI 2011AA)
10025671 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
ECOG performance status of <=2
Item
ECOG performance status finding <=2
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Measurable disease according to modified RECIST
Item
Measurable disease according to modified RECIST
boolean
C1513041 (UMLS CUI 2011AA)
Life expectancy >12 weeks
Item
Life expectancy >12 weeks
boolean
C0023671 (UMLS CUI 2011AA)
LDH <= 2.0 x ULN
Item
LDH <= 2.0 x ULN
boolean
C0022917 (UMLS CUI 2011AA)
259319003 (SNOMED CT 2011_0131)
MTHU002348 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Clinical lab values within protocol parameters.
Item
Clinical lab values within protocol parameters.
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
C2699426 (UMLS CUI 2011AA)
C2348563 (UMLS CUI 2011AA)
C0549193 (UMLS CUI 2011AA)
246446004 (SNOMED CT 2011_0131)
At least 18 years old and able and willing to provide informed consent to participate
Item
At least 18 years old and able and willing to provide informed consent to participate
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0021430 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Previous cytotoxic chemotherapy treatment for melanoma
Item
Previous cytotoxic chemotherapy treatment for melanoma
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0677881 (UMLS CUI 2011AA)
C0025202 (UMLS CUI 2011AA)
2092003 (SNOMED CT 2011_0131)
10025650 (MedDRA 14.1)
Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.
Item
Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.
boolean
C1514756 (UMLS CUI 2011AA)
CL031856 (UMLS CUI 2011AA)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
C1171350 (UMLS CUI 2011AA)
C0005527 (UMLS CUI 2011AA)
C0042209 (UMLS CUI 2011AA)
C0949266 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0025202 (UMLS CUI 2011AA)
2092003 (SNOMED CT 2011_0131)
10025650 (MedDRA 14.1)
Presence of brain metastases
Item
Presence of brain metastases
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
Presence or history (<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
Item
Presence or history (<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0085183 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0699893 (UMLS CUI 2011AA)
10040810 (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)
Female subjects who are pregnant or nursing
Item
Female subjects who are pregnant or nursing
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial