ID

5109

Description

ODM derived from http://clinicaltrials.gov/show/NCT01239797

Link

http://clinicaltrials.gov/show/NCT01239797

Keywords

Versions (3)
  1. 2/12/13 2/12/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 7/9/15 7/9/15 - Martin Dugas
Uploaded on

April 19, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01239797 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
Multiple Myeloma
Description

Multiple Myeloma

Data type

boolean

Alias
UMLS CUI 2011AA
C0026764
Documented progression from most recent line of therapy
Description

Documented progression from most recent line of therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0449258
SNOMED CT 2011_0131
246450006
UMLS CUI 2011AA
C1513491
HL7 V3 2006_05
RECENT
UMLS CUI 2011AA
CL415196
UMLS CUI 2011AA
C0039798
1 - 3 prior lines of therapy
Description

1 - 3 prior lines of therapy

Data type

boolean

Alias
UMLS CUI 2011AA
CL415096
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
CL415196
UMLS CUI 2011AA
C0039798
Measurable Disease
Description

Measurable disease

Data type

boolean

Alias
UMLS CUI 2011AA
C1513041
Life expectancy >=3 months
Description

Life expectancy >=3 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
Prior treatment with Lenalidomide permitted if:
Description

Prior treatment with Lenalidomide permitted if:

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1144149
SNOMED CT 2011_0131
421471009
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
C0750557
Best response achieved was ≥ Partial Response (PR)
Description

Best response achieved was ≥ Partial Response (PR)

Data type

boolean

Alias
UMLS CUI 2011AA
C2986560
UMLS CUI 2011AA
C0680378
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C1521726
SNOMED CT 2011_0131
103337004
Patient was not refractory
Description

Patient was not refractory

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
Patient did not discontinue due to a Grade ≥ 3 related adverse event
Description

Patient did not discontinue due to a Grade ≥ 3 related adverse event

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0457454
SNOMED CT 2011_0131
278308006
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C1519275
UMLS CUI 2011AA
CL427997
UMLS CUI 2011AA
C1705232
Subject did not receive > 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
Description

Subject did not receive > 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205455
SNOMED CT 2011_0131
422113007, 36987007
UMLS CUI 2011AA
C0439596
SNOMED CT 2011_0131
44180009
UMLS CUI 2011AA
C1144149
SNOMED CT 2011_0131
421471009
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
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)
Multiple Myeloma
Item
Multiple Myeloma
boolean
C0026764 (UMLS CUI 2011AA)
Documented progression from most recent line of therapy
Item
Documented progression from most recent line of therapy
boolean
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0449258 (UMLS CUI 2011AA)
246450006 (SNOMED CT 2011_0131)
C1513491 (UMLS CUI 2011AA)
RECENT (HL7 V3 2006_05)
CL415196 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
1 - 3 prior lines of therapy
Item
1 - 3 prior lines of therapy
boolean
CL415096 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL415196 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Measurable disease
Item
Measurable Disease
boolean
C1513041 (UMLS CUI 2011AA)
Life expectancy >=3 months
Item
Life expectancy >=3 months
boolean
C0023671 (UMLS CUI 2011AA)
Prior treatment with Lenalidomide permitted if:
Item
Prior treatment with Lenalidomide permitted if:
boolean
C1514463 (UMLS CUI 2011AA)
C1144149 (UMLS CUI 2011AA)
421471009 (SNOMED CT 2011_0131)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
Best response achieved was ≥ Partial Response (PR)
Item
Best response achieved was ≥ Partial Response (PR)
boolean
C2986560 (UMLS CUI 2011AA)
C0680378 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C1521726 (UMLS CUI 2011AA)
103337004 (SNOMED CT 2011_0131)
Patient was not refractory
Item
Patient was not refractory
boolean
C1518422 (UMLS CUI 2011AA)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
Patient did not discontinue due to a Grade ≥ 3 related adverse event
Item
Patient did not discontinue due to a Grade ≥ 3 related adverse event
boolean
C1518422 (UMLS CUI 2011AA)
C0457454 (UMLS CUI 2011AA)
278308006 (SNOMED CT 2011_0131)
CL420107 (UMLS CUI 2011AA)
C1519275 (UMLS CUI 2011AA)
CL427997 (UMLS CUI 2011AA)
C1705232 (UMLS CUI 2011AA)
Subject did not receive > 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
Item
Subject did not receive > 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
boolean
C1518422 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205455 (UMLS CUI 2011AA)
422113007, 36987007 (SNOMED CT 2011_0131)
C0439596 (UMLS CUI 2011AA)
44180009 (SNOMED CT 2011_0131)
C1144149 (UMLS CUI 2011AA)
421471009 (SNOMED CT 2011_0131)
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)
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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