ID

5042

Description

ODM derived from http://clinicaltrials.gov/show/NCT00909597

Link

http://clinicaltrials.gov/show/NCT00909597

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 4/17/14 4/17/14 - Julian Varghese
Uploaded on

April 17, 2014

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00909597 Diabetes Mellitus, Type 2

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 75 Years
Description

age 18 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
type 2 diabetes mellitus
Description

type 2 diabetes mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening
Description

treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening

Data type

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0038766
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
UMLS CUI 2011AA
C0038766
HbA1c >=7.0% and <=10% at screening
Description

HbA1c >=7.0% and <=10% at screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
stable weight +/-5% for >=12 weeks prior to screening.
Description

stable weight +/-5% for >=12 weeks prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
Description

type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes

Data type

boolean

Alias
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C0273163
SNOMED CT 2011_0131
61823004
MedDRA 14.1
10033627
ICD-10-CM Version 2010
S36.2
UMLS CUI 2011AA
C0271640
SNOMED CT 2011_0131
8801005
ICD-9-CM Version 2011
249
clinically significant diabetic complications
Description

clinically significant diabetic complications

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0342257
SNOMED CT 2011_0131
74627003
MedDRA 14.1
10061104
ICD-9-CM Version 2011
250.9
clinically symptomatic gastrointestinal disease
Description

clinically symptomatic gastrointestinal disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C0017178
SNOMED CT 2011_0131
119292006
MedDRA 14.1
10017944
>3 episodes of severe hypoglycemia within 6 months before screening.
Description

>3 episodes of severe hypoglycemia within 6 months before screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0332189
SNOMED CT 2011_0131
272128006
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0020615
SNOMED CT 2011_0131
302866003
MedDRA 14.1
10020993
ICD-10-CM Version 2010
E16.2
ICD-9-CM Version 2011
251.2
CTCAE 1105E
E12322
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 75 Years
Item
age 18 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
type 2 diabetes mellitus
Item
type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI 2011AA)
treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening
Item
treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening
boolean
CL415147 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0038766 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
C0038766 (UMLS CUI 2011AA)
HbA1c >=7.0% and <=10% at screening
Item
HbA1c >=7.0% and <=10% at screening
boolean
C0019018 (UMLS CUI 2011AA)
stable weight +/-5% for >=12 weeks prior to screening.
Item
stable weight +/-5% for >=12 weeks prior to screening.
boolean
C0005910 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
Item
type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
boolean
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C0273163 (UMLS CUI 2011AA)
61823004 (SNOMED CT 2011_0131)
10033627 (MedDRA 14.1)
S36.2 (ICD-10-CM Version 2010)
C0271640 (UMLS CUI 2011AA)
8801005 (SNOMED CT 2011_0131)
249 (ICD-9-CM Version 2011)
clinically significant diabetic complications
Item
clinically significant diabetic complications
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0342257 (UMLS CUI 2011AA)
74627003 (SNOMED CT 2011_0131)
10061104 (MedDRA 14.1)
250.9 (ICD-9-CM Version 2011)
clinically symptomatic gastrointestinal disease
Item
clinically symptomatic gastrointestinal disease
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
>3 episodes of severe hypoglycemia within 6 months before screening.
Item
>3 episodes of severe hypoglycemia within 6 months before screening.
boolean
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0020615 (UMLS CUI 2011AA)
302866003 (SNOMED CT 2011_0131)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial