ID

4919

Beschreibung

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

Link

http://clinicaltrials.gov/show/NCT00522834

Stichworte

Versionen (3)
  1. 10.12.13 10.12.13 - Martin Dugas
  2. 14.04.14 14.04.14 - Julian Varghese
  3. 20.09.21 20.09.21 -
Hochgeladen am

14. April 2014

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility NCT00522834 Melanoma

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

age at least 18 Years

Datentyp

boolean

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

Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin

Datentyp

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
Beschreibung

ECOG performance status of <=2

Datentyp

boolean

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

Measurable disease according to modified RECIST

Datentyp

boolean

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

Life expectancy >12 weeks

Datentyp

boolean

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

LDH <= 2.0 x ULN

Datentyp

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.
Beschreibung

Clinical lab values within protocol parameters.

Datentyp

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
Beschreibung

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

Datentyp

boolean

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

Exclusion Criteria

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

Previous cytotoxic chemotherapy treatment for melanoma

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Presence of brain metastases

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Female subjects who are pregnant or nursing

Datentyp

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
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
Zum Seitenanfang zurückkehren 

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