ID

3766

Description

ODM derived from http://clinicaltrials.gov/show/NCT01335399

Link

http://clinicaltrials.gov/show/NCT01335399

Keywords

Versions (1)
  1. 3/21/13 3/21/13 - Martin Dugas
Uploaded on

March 21, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01335399 Multiple Myeloma

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
Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
Description

Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:

Data type

boolean

Alias
UMLS CUI 2011AA
C2585997
SNOMED CT 2011_0131
441308009
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0026764
SNOMED CT 2011_0131
109989006
MedDRA 14.1
10028228
ICD-10-CM Version 2010
C90.0
ICD-9-CM Version 2011
203.0
have not received any prior systemic anti-myeloma therapy AND
Description

have not received any prior systemic anti-myeloma therapy AND

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
CL324441
Measurable Disease
Description

have measurable disease AND

Data type

boolean

Alias
UMLS CUI 2011AA
C1513041
are not candidates for high-dose therapy plus stem-cell transplantation because of age (>= 65 years) or coexisting conditions
Description

are not candidates for high-dose therapy plus stem-cell transplantation because of age (>= 65 years) or coexisting conditions

Data type

boolean

Alias
UMLS CUI 2011AA
C1555471
HL7 V3 2006_05
NELG
UMLS CUI 2011AA
C0444956
SNOMED CT 2011_0131
261829003
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332287
SNOMED CT 2011_0131
20401003
UMLS CUI 2011AA
C1504389
MedDRA 14.1
10063581
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0243086
Exclusion Criteria
Description

Exclusion Criteria

Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
Description

Subjects with non-secretory or oligo-secretory or free light-chain only myeloma

Data type

boolean

Alias
UMLS CUI 2011AA
C0456845
SNOMED CT 2011_0131
277580004
MedDRA 14.1
10029662
UMLS CUI 2011AA
C0205251
SNOMED CT 2011_0131
62482003
UMLS CUI 2011AA
C0036536
UMLS CUI 2011AA
CL324441
UMLS CUI 2011AA
C0332296
SNOMED CT 2011_0131
37837009
UMLS CUI 2011AA
C0456844
SNOMED CT 2011_0131
277579002
Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
Description

Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions

Data type

boolean

Alias
UMLS CUI 2011AA
C1531608
SNOMED CT 2011_0131
413587002
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C2585107
SNOMED CT 2011_0131
440422002
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0221204
Monoclonal gammopathy of undetermined significance (MGUS)
Description

Monoclonal Gammopathy of Undetermined Significance (MGUS)

Data type

boolean

Alias
UMLS CUI 2011AA
C0026470
SNOMED CT 2011_0131
277577000
MedDRA 14.1
10027863
ICD-10-CM Version 2010
D47.2
Active plasma cell leukemia
Description

Active plasma cell leukemia

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0023484
SNOMED CT 2011_0131
95210003
MedDRA 14.1
10035222
ICD-10-CM Version 2010
C90.1
ICD-9-CM Version 2011
203.1
Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)
Description

Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)

Data type

boolean

Alias
UMLS CUI 2011AA
C0856706
MedDRA 14.1
10019738
UMLS CUI 2011AA
C1112419
MedDRA 14.1
10057394
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
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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)
Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
Item
Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
boolean
C2585997 (UMLS CUI 2011AA)
441308009 (SNOMED CT 2011_0131)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0026764 (UMLS CUI 2011AA)
109989006 (SNOMED CT 2011_0131)
10028228 (MedDRA 14.1)
C90.0 (ICD-10-CM Version 2010)
203.0 (ICD-9-CM Version 2011)
have not received any prior systemic anti-myeloma therapy AND
Item
have not received any prior systemic anti-myeloma therapy AND
boolean
C1518422 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
CL324441 (UMLS CUI 2011AA)
have measurable disease AND
Item
Measurable Disease
boolean
C1513041 (UMLS CUI 2011AA)
are not candidates for high-dose therapy plus stem-cell transplantation because of age (>= 65 years) or coexisting conditions
Item
are not candidates for high-dose therapy plus stem-cell transplantation because of age (>= 65 years) or coexisting conditions
boolean
C1555471 (UMLS CUI 2011AA)
NELG (HL7 V3 2006_05)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0332287 (UMLS CUI 2011AA)
20401003 (SNOMED CT 2011_0131)
C1504389 (UMLS CUI 2011AA)
10063581 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0243086 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
Item
Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
boolean
C0456845 (UMLS CUI 2011AA)
277580004 (SNOMED CT 2011_0131)
10029662 (MedDRA 14.1)
C0205251 (UMLS CUI 2011AA)
62482003 (SNOMED CT 2011_0131)
C0036536 (UMLS CUI 2011AA)
CL324441 (UMLS CUI 2011AA)
C0332296 (UMLS CUI 2011AA)
37837009 (SNOMED CT 2011_0131)
C0456844 (UMLS CUI 2011AA)
277579002 (SNOMED CT 2011_0131)
Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
Item
Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
boolean
C1531608 (UMLS CUI 2011AA)
413587002 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C2585107 (UMLS CUI 2011AA)
440422002 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0221204 (UMLS CUI 2011AA)
Monoclonal Gammopathy of Undetermined Significance (MGUS)
Item
Monoclonal gammopathy of undetermined significance (MGUS)
boolean
C0026470 (UMLS CUI 2011AA)
277577000 (SNOMED CT 2011_0131)
10027863 (MedDRA 14.1)
D47.2 (ICD-10-CM Version 2010)
Active plasma cell leukemia
Item
Active plasma cell leukemia
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0023484 (UMLS CUI 2011AA)
95210003 (SNOMED CT 2011_0131)
10035222 (MedDRA 14.1)
C90.1 (ICD-10-CM Version 2010)
203.1 (ICD-9-CM Version 2011)
Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)
Item
Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)
boolean
C0856706 (UMLS CUI 2011AA)
10019738 (MedDRA 14.1)
C1112419 (UMLS CUI 2011AA)
10057394 (MedDRA 14.1)
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
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