ID

5073

Description

ODM derived from http://clinicaltrials.gov/show/NCT01042769

Link

http://clinicaltrials.gov/show/NCT01042769

Keywords

  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
Uploaded on

April 17, 2014

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT01042769 Diabetes Mellitus, Type 2

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
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

Adults >18 years of age

Data type

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
Type 2 diabetes mellitus
Description

Type 2 diabetes mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
Hospitalization for ACS event and randomization 2-6 weeks after day of hospitalization
Description

Hospitalization for ACS event and randomization 2-6 weeks after day of hospitalization

Data type

boolean

Alias
UMLS CUI 2011AA
C0019993
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
UMLS CUI 2011AA
C0948089
SNOMED CT 2011_0131
394659003
MedDRA 14.1
10051592
CTCAE 1105E
E10066
UMLS CUI 2011AA
C0441471
SNOMED CT 2011_0131
272379006
LOINC Version 232
MTHU019184
UMLS CUI 2011AA
C0034656
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Estimated glomerular filtration rate <45mL/min/1.73m2
Description

Estimated glomerular filtration rate <45mL/min/1.73m2

Data type

boolean

Alias
UMLS CUI 2011AA
C0750572
SNOMED CT 2011_0131
414135002
UMLS CUI 2011AA
C0017654
SNOMED CT 2011_0131
80274001
MedDRA 14.1
10018355
Concomitant treatment with a thiazolidinedione and/or fibrate
Description

Concomitant treatment with a thiazolidinedione and/or fibrate

Data type

boolean

Alias
UMLS CUI 2011AA
C1707479
UMLS CUI 2011AA
C1257987
SNOMED CT 2011_0131
109086001
UMLS CUI 2011AA
C1449704
Triglyceride
Description

Triglycerides >400 mg/dL

Data type

boolean

Alias
UMLS CUI 2011AA
C0041004
SNOMED CT 2011_0131
85600001
LOINC Version 232
MTHU003166
Anaemia
Description

Anaemia

Data type

boolean

Alias
UMLS CUI 2011AA
C0002871
SNOMED CT 2011_0131
271737000
MedDRA 14.1
10002034
LOINC Version 232
MTHU020823
ICD-10-CM Version 2010
D64.9
ICD-9-CM Version 2011
285.9
CTCAE 1105E
E10010
Symptomatic congestive heart failure classified as NYHA class II-IV
Description

Symptomatic congestive heart failure classified as NYHA class II-IV

Data type

boolean

Alias
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C0008902
SNOMED CT 2011_0131
278201002
UMLS CUI 2011AA
C1319794
SNOMED CT 2011_0131
421704003
MedDRA 14.1
10064080
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Adults >18 years of age
Item
Adult (person)
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
Type 2 diabetes mellitus
Item
Type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI 2011AA)
Hospitalization for ACS event and randomization 2-6 weeks after day of hospitalization
Item
Hospitalization for ACS event and randomization 2-6 weeks after day of hospitalization
boolean
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
C0948089 (UMLS CUI 2011AA)
394659003 (SNOMED CT 2011_0131)
10051592 (MedDRA 14.1)
E10066 (CTCAE 1105E)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
C0034656 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Estimated glomerular filtration rate <45mL/min/1.73m2
Item
Estimated glomerular filtration rate <45mL/min/1.73m2
boolean
C0750572 (UMLS CUI 2011AA)
414135002 (SNOMED CT 2011_0131)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
Concomitant treatment with a thiazolidinedione and/or fibrate
Item
Concomitant treatment with a thiazolidinedione and/or fibrate
boolean
C1707479 (UMLS CUI 2011AA)
C1257987 (UMLS CUI 2011AA)
109086001 (SNOMED CT 2011_0131)
C1449704 (UMLS CUI 2011AA)
Triglycerides >400 mg/dL
Item
Triglyceride
boolean
C0041004 (UMLS CUI 2011AA)
85600001 (SNOMED CT 2011_0131)
MTHU003166 (LOINC Version 232)
Anaemia
Item
Anaemia
boolean
C0002871 (UMLS CUI 2011AA)
271737000 (SNOMED CT 2011_0131)
10002034 (MedDRA 14.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE 1105E)
Symptomatic congestive heart failure classified as NYHA class II-IV
Item
Symptomatic congestive heart failure classified as NYHA class II-IV
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0008902 (UMLS CUI 2011AA)
278201002 (SNOMED CT 2011_0131)
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)

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