ID

5126

Description

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

Link

http://clinicaltrials.gov/show/NCT01307397

Keywords

Versions (2)
  1. 3/21/13 3/21/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
Uploaded on

April 19, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00003620 NCT01307397 Malignant Melanoma

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Adult (person)
Description

Adult patients, >/= 18 years of age

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

boolean

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

Adequate hematologic, renal and liver function

Data type

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
Exclusion Criteria
Description

Exclusion Criteria

Evidence of symptomatic CNS lesions
Description

Evidence of symptomatic CNS lesions

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

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
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
Description

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

Data type

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
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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
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Adult patients, >/= 18 years of age
Item
Adult (person)
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
Exclusion Criteria
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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