ID

43449

Description

ODM derived from http://clinicaltrials.gov/show/NCT00770653

Link

http://clinicaltrials.gov/show/NCT00770653

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00770653 Diabetes Mellitus

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 according to the American Diabetes Association Criteria.
Description

Type 2 diabetes according to the American Diabetes Association Criteria.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1705019
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0566588
SNOMED CT 2011_0131
289172004
Treatment with individual maximal tolerated dose of metformin (850 - 2000 mg) as monotherapy within the last 12 weeks
Description

Treatment with individual maximal tolerated dose of metformin (850 - 2000 mg) as monotherapy within the last 12 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0752079
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
Hemoglobin, Glycosylated
Description

Glycosylated Hemoglobin >= 6.5% and <= 9%.

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
259689004
LOINC Version 232
MTHU020323
Dyslipidemia defined as high-density lipoprotein cholesterol <= 1.03 mmol/l (40 mg/dL) and/or triglycerides >= 1.7 mmol/l (150 mg/dL).
Description

Dyslipidemia defined as high-density lipoprotein cholesterol <= 1.03 mmol/l (40 mg/dL) and/or triglycerides >= 1.7 mmol/l (150 mg/dL).

Data type

boolean

Alias
UMLS CUI 2011AA
C0242339
SNOMED CT 2011_0131
370992007
MedDRA 14.1
10058108
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0023822
SNOMED CT 2011_0131
102737005
UMLS CUI 2011AA
C0041004
SNOMED CT 2011_0131
85600001
LOINC Version 232
MTHU003166
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Description

Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0232973
SNOMED CT 2011_0131
60001007
UMLS CUI 2011AA
C2826207
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Diabetes Mellitus, Insulin-Dependent
Description

Type 1 diabetes mellitus.

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
DIABETES MELLITUS, INSULIN-DEPENDENT, 2
Description

Insulin-dependent type 2 diabetes mellitus.

Data type

boolean

Alias
UMLS CUI 2011AA
C1852092
Treatment or history of treatment with any insulin formulation other than emergency for more than 2 weeks.
Description

Treatment or history of treatment with any insulin formulation other than emergency for more than 2 weeks.

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
C1705957
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0175673
SNOMED CT 2011_0131
25876001
Treatment with other oral antidiabetic drugs in addition to metformin within the last 12 weeks.
Description

Treatment with other oral antidiabetic drugs in addition to metformin within the last 12 weeks.

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0935929
SNOMED CT 2011_0131
373245004
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C0025598
SNOMED CT 2011_0131
372567009
LOINC Version 232
MTHU016062
Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
Description

Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.

Data type

boolean

Alias
UMLS CUI 2011AA
C0489531
LOINC Version 232
MTHU001065
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C2348205
UMLS CUI 2011AA
C0220807
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Description

Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C1554075
HL7 V3 2006_05
NP
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1521941
LOINC Version 232
MTHU034709
UMLS CUI 2011AA
C1360419
UMLS CUI 2011AA
C0013231
SNOMED CT 2011_0131
329505003, 80288002
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0013175
SNOMED CT 2011_0131
185922005
Heparin (and heparin-like drugs)
Description

Heparin (and heparin-like drugs)

Data type

boolean

Alias
UMLS CUI 2011AA
C0019134
SNOMED CT 2011_0131
372877000
LOINC Version 232
MTHU003766
UMLS CUI 2011AA
C2348205
UMLS CUI 2011AA
C0013227
Cumarin, Coumarin anticoagulant
Description

coumarin

Data type

boolean

Alias
UMLS CUI 2011AA
C0010206
SNOMED CT 2011_0131
373307003
Phenprocoumon (substance)
Description

phenprocoumon

Data type

boolean

Alias
UMLS CUI 2011AA
C0031444
SNOMED CT 2011_0131
59488002
LOINC Version 232
MTHU016364
Hirudin (substance)
Description

hirudin

Data type

boolean

Alias
UMLS CUI 2011AA
C0019573
SNOMED CT 2011_0131
414407009
LOINC Version 232
MTHU026944
Protein C (substance)
Description

Protein C

Data type

boolean

Alias
UMLS CUI 2011AA
C0033621
SNOMED CT 2011_0131
25525005
LOINC Version 232
MTHU021552
Fondaparinux (product)
Description

Fondaparinux

Data type

boolean

Alias
UMLS CUI 2011AA
C0701492
SNOMED CT 2011_0131
395236007
LOINC Version 232
MTHU025935
Antithrombin III (substance)
Description

antithrombin III

Data type

boolean

Alias
UMLS CUI 2011AA
C0003438
SNOMED CT 2011_0131
34086003
LOINC Version 232
MTHU008554
Peroxisome Proliferation Activating Receptor (gamma) agonists
Description

Peroxisome Proliferation Activating Receptor (gamma) agonists

Data type

boolean

Alias
UMLS CUI 2011AA
C0166417
UMLS CUI 2011AA
C0243192
Treatment within the last 12 weeks with:
Description

Treatment within the last 12 weeks with:

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205458
SNOMED CT 2011_0131
82809009
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Fibrates
Description

fibrates

Data type

boolean

Alias
UMLS CUI 2011AA
C1449704
Gemfibrozil (product)
Description

gemfibrozil

Data type

boolean

Alias
UMLS CUI 2011AA
C0017245
SNOMED CT 2011_0131
35282000
LOINC Version 232
MTHU002557
Nicotinic acid (substance)
Description

niacin

Data type

boolean

Alias
UMLS CUI 2011AA
C0027996
SNOMED CT 2011_0131
273943001
LOINC Version 232
MTHU002113
Rifampin
Description

Rifampicin

Data type

boolean

Alias
UMLS CUI 2011AA
C0035608
SNOMED CT 2011_0131
387159009
LOINC Version 232
MTHU008474
Changes in dosage of any statin treatment to lower low-density lipoprotein within 2 weeks before study entry and during study participation interval.
Description

Changes in dosage of any statin treatment to lower low-density lipoprotein within 2 weeks before study entry and during study participation interval.

Data type

boolean

Alias
UMLS CUI 2011AA
C2347524
UMLS CUI 2011AA
C0360714
SNOMED CT 2011_0131
372912004
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C2003888
UMLS CUI 2011AA
C0023823
SNOMED CT 2011_0131
22244007
LOINC Version 232
MTHU005011
Changes in dosage of any anticoagulant treatment with acetyl salicylic acid and/or clopidogrel within 2 weeks before study entry and during study participation interval.
Description

Changes in dosage of any anticoagulant treatment with acetyl salicylic acid and/or clopidogrel within 2 weeks before study entry and during study participation interval.

Data type

boolean

Alias
UMLS CUI 2011AA
C2347524
UMLS CUI 2011AA
C0150457
SNOMED CT 2011_0131
182764009
MedDRA 14.1
10053468
UMLS CUI 2011AA
C0004057
SNOMED CT 2011_0131
7947003
UMLS CUI 2011AA
C0070166
SNOMED CT 2011_0131
386952008
Start of statin and/or anticoagulant treatment during study participation interval.
Description

Start of statin and/or anticoagulant treatment during study participation interval.

Data type

boolean

Alias
UMLS CUI 2011AA
C0360714
SNOMED CT 2011_0131
372912004
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0150457
SNOMED CT 2011_0131
182764009
MedDRA 14.1
10053468
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
History of severe or multiple allergies and/ or acute severe infections.
Description

History of severe or multiple allergies and/ or acute severe infections.

Data type

boolean

Alias
UMLS CUI 2011AA
C0489531
LOINC Version 232
MTHU001065
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0455609
SNOMED CT 2011_0131
161614004
UMLS CUI 2011AA
C0275518
SNOMED CT 2011_0131
63171007
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
Description

Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
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
Progressive fatal disease.
Description

Progressive fatal disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1335499
Any elective surgery during study participation.
Description

Any elective surgery during study participation.

Data type

boolean

Alias
UMLS CUI 2011AA
C0206058
SNOMED CT 2011_0131
274075007
MedDRA 14.1
10058829
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
History of drug or alcohol abuse within the last 5 years.
Description

History of drug or alcohol abuse within the last 5 years.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085762
A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase and/or aspartate aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine > 1.2 mg/dL in women and > 1.5 mg/dL in men, glomerular filtration rate < 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator, history of macular edema.
Description

A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase and/or aspartate aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine > 1.2 mg/dL in women and > 1.5 mg/dL in men, glomerular filtration rate < 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator, history of macular edema.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C1319793
SNOMED CT 2011_0131
420300004
MedDRA 14.1
10064079
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
UMLS CUI 2011AA
C0035204
SNOMED CT 2011_0131
50043002
MedDRA 14.1
10038683
ICD-10-CM Version 2010
J98.9
ICD-9-CM Version 2011
519.9
UMLS CUI 2011AA
C0017178
SNOMED CT 2011_0131
119292006
MedDRA 14.1
10017944
UMLS CUI 2011AA
C1869009
MedDRA 14.1
20000005
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0017654
SNOMED CT 2011_0131
80274001
MedDRA 14.1
10018355
UMLS CUI 2011AA
C2711451
SNOMED CT 2011_0131
442407001
UMLS CUI 2011AA
C0027765
SNOMED CT 2011_0131
118940003
MedDRA 14.1
10029202
ICD-10-CM Version 2010
G98.8
ICD-9-CM Version 2011
349.9
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0018939
SNOMED CT 2011_0131
191124002
MedDRA 14.1
10061590
ICD-10-CM Version 2010
D75.9
ICD-9-CM Version 2011
289.9
UMLS CUI 2011AA
C0271051
SNOMED CT 2011_0131
37231002
MedDRA 14.1
10025415
Blood donation within the last 30 days.
Description

Blood donation within the last 30 days.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005794
SNOMED CT 2011_0131
25179006
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
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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
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 according to the American Diabetes Association Criteria.
Item
Type 2 diabetes according to the American Diabetes Association Criteria.
boolean
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1705019 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
C0566588 (UMLS CUI 2011AA)
289172004 (SNOMED CT 2011_0131)
Treatment with individual maximal tolerated dose of metformin (850 - 2000 mg) as monotherapy within the last 12 weeks
Item
Treatment with individual maximal tolerated dose of metformin (850 - 2000 mg) as monotherapy within the last 12 weeks
boolean
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0752079 (UMLS CUI 2011AA)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
Glycosylated Hemoglobin >= 6.5% and <= 9%.
Item
Hemoglobin, Glycosylated
boolean
C0019018 (UMLS CUI 2011AA)
259689004 (SNOMED CT 2011_0131)
MTHU020323 (LOINC Version 232)
Dyslipidemia defined as high-density lipoprotein cholesterol <= 1.03 mmol/l (40 mg/dL) and/or triglycerides >= 1.7 mmol/l (150 mg/dL).
Item
Dyslipidemia defined as high-density lipoprotein cholesterol <= 1.03 mmol/l (40 mg/dL) and/or triglycerides >= 1.7 mmol/l (150 mg/dL).
boolean
C0242339 (UMLS CUI 2011AA)
370992007 (SNOMED CT 2011_0131)
10058108 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
C0023822 (UMLS CUI 2011AA)
102737005 (SNOMED CT 2011_0131)
C0041004 (UMLS CUI 2011AA)
85600001 (SNOMED CT 2011_0131)
MTHU003166 (LOINC Version 232)
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Item
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
C2826207 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Type 1 diabetes mellitus.
Item
Diabetes Mellitus, Insulin-Dependent
boolean
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
Insulin-dependent type 2 diabetes mellitus.
Item
DIABETES MELLITUS, INSULIN-DEPENDENT, 2
boolean
C1852092 (UMLS CUI 2011AA)
Treatment or history of treatment with any insulin formulation other than emergency for more than 2 weeks.
Item
Treatment or history of treatment with any insulin formulation other than emergency for more than 2 weeks.
boolean
C0039798 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C1705957 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0175673 (UMLS CUI 2011AA)
25876001 (SNOMED CT 2011_0131)
Treatment with other oral antidiabetic drugs in addition to metformin within the last 12 weeks.
Item
Treatment with other oral antidiabetic drugs in addition to metformin within the last 12 weeks.
boolean
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0025598 (UMLS CUI 2011AA)
372567009 (SNOMED CT 2011_0131)
MTHU016062 (LOINC Version 232)
Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
Item
Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
boolean
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C2348205 (UMLS CUI 2011AA)
C0220807 (UMLS CUI 2011AA)
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Item
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
boolean
C1512806 (UMLS CUI 2011AA)
C1554075 (UMLS CUI 2011AA)
NP (HL7 V3 2006_05)
C0013227 (UMLS CUI 2011AA)
C1521941 (UMLS CUI 2011AA)
MTHU034709 (LOINC Version 232)
C1360419 (UMLS CUI 2011AA)
C0013231 (UMLS CUI 2011AA)
329505003, 80288002 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0013175 (UMLS CUI 2011AA)
185922005 (SNOMED CT 2011_0131)
Heparin (and heparin-like drugs)
Item
Heparin (and heparin-like drugs)
boolean
C0019134 (UMLS CUI 2011AA)
372877000 (SNOMED CT 2011_0131)
MTHU003766 (LOINC Version 232)
C2348205 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
coumarin
Item
Cumarin, Coumarin anticoagulant
boolean
C0010206 (UMLS CUI 2011AA)
373307003 (SNOMED CT 2011_0131)
phenprocoumon
Item
Phenprocoumon (substance)
boolean
C0031444 (UMLS CUI 2011AA)
59488002 (SNOMED CT 2011_0131)
MTHU016364 (LOINC Version 232)
hirudin
Item
Hirudin (substance)
boolean
C0019573 (UMLS CUI 2011AA)
414407009 (SNOMED CT 2011_0131)
MTHU026944 (LOINC Version 232)
Protein C
Item
Protein C (substance)
boolean
C0033621 (UMLS CUI 2011AA)
25525005 (SNOMED CT 2011_0131)
MTHU021552 (LOINC Version 232)
Fondaparinux
Item
Fondaparinux (product)
boolean
C0701492 (UMLS CUI 2011AA)
395236007 (SNOMED CT 2011_0131)
MTHU025935 (LOINC Version 232)
antithrombin III
Item
Antithrombin III (substance)
boolean
C0003438 (UMLS CUI 2011AA)
34086003 (SNOMED CT 2011_0131)
MTHU008554 (LOINC Version 232)
Peroxisome Proliferation Activating Receptor (gamma) agonists
Item
Peroxisome Proliferation Activating Receptor (gamma) agonists
boolean
C0166417 (UMLS CUI 2011AA)
C0243192 (UMLS CUI 2011AA)
Treatment within the last 12 weeks with:
Item
Treatment within the last 12 weeks with:
boolean
C0039798 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C0205458 (UMLS CUI 2011AA)
82809009 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
fibrates
Item
Fibrates
boolean
C1449704 (UMLS CUI 2011AA)
gemfibrozil
Item
Gemfibrozil (product)
boolean
C0017245 (UMLS CUI 2011AA)
35282000 (SNOMED CT 2011_0131)
MTHU002557 (LOINC Version 232)
niacin
Item
Nicotinic acid (substance)
boolean
C0027996 (UMLS CUI 2011AA)
273943001 (SNOMED CT 2011_0131)
MTHU002113 (LOINC Version 232)
Rifampicin
Item
Rifampin
boolean
C0035608 (UMLS CUI 2011AA)
387159009 (SNOMED CT 2011_0131)
MTHU008474 (LOINC Version 232)
Changes in dosage of any statin treatment to lower low-density lipoprotein within 2 weeks before study entry and during study participation interval.
Item
Changes in dosage of any statin treatment to lower low-density lipoprotein within 2 weeks before study entry and during study participation interval.
boolean
C2347524 (UMLS CUI 2011AA)
C0360714 (UMLS CUI 2011AA)
372912004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2003888 (UMLS CUI 2011AA)
C0023823 (UMLS CUI 2011AA)
22244007 (SNOMED CT 2011_0131)
MTHU005011 (LOINC Version 232)
Changes in dosage of any anticoagulant treatment with acetyl salicylic acid and/or clopidogrel within 2 weeks before study entry and during study participation interval.
Item
Changes in dosage of any anticoagulant treatment with acetyl salicylic acid and/or clopidogrel within 2 weeks before study entry and during study participation interval.
boolean
C2347524 (UMLS CUI 2011AA)
C0150457 (UMLS CUI 2011AA)
182764009 (SNOMED CT 2011_0131)
10053468 (MedDRA 14.1)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
C0070166 (UMLS CUI 2011AA)
386952008 (SNOMED CT 2011_0131)
Start of statin and/or anticoagulant treatment during study participation interval.
Item
Start of statin and/or anticoagulant treatment during study participation interval.
boolean
C0360714 (UMLS CUI 2011AA)
372912004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0150457 (UMLS CUI 2011AA)
182764009 (SNOMED CT 2011_0131)
10053468 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
History of severe or multiple allergies and/ or acute severe infections.
Item
History of severe or multiple allergies and/ or acute severe infections.
boolean
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0455609 (UMLS CUI 2011AA)
161614004 (SNOMED CT 2011_0131)
C0275518 (UMLS CUI 2011AA)
63171007 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
Item
Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
boolean
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (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)
Progressive fatal disease.
Item
Progressive fatal disease.
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
Any elective surgery during study participation.
Item
Any elective surgery during study participation.
boolean
C0206058 (UMLS CUI 2011AA)
274075007 (SNOMED CT 2011_0131)
10058829 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
History of drug or alcohol abuse within the last 5 years.
Item
History of drug or alcohol abuse within the last 5 years.
boolean
C0085762 (UMLS CUI 2011AA)
A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase and/or aspartate aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine > 1.2 mg/dL in women and > 1.5 mg/dL in men, glomerular filtration rate < 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator, history of macular edema.
Item
A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase and/or aspartate aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine > 1.2 mg/dL in women and > 1.5 mg/dL in men, glomerular filtration rate < 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator, history of macular edema.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C1319793 (UMLS CUI 2011AA)
420300004 (SNOMED CT 2011_0131)
10064079 (MedDRA 14.1)
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)
C0035204 (UMLS CUI 2011AA)
50043002 (SNOMED CT 2011_0131)
10038683 (MedDRA 14.1)
J98.9 (ICD-10-CM Version 2010)
519.9 (ICD-9-CM Version 2011)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C1869009 (UMLS CUI 2011AA)
20000005 (MedDRA 14.1)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
C2711451 (UMLS CUI 2011AA)
442407001 (SNOMED CT 2011_0131)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C0271051 (UMLS CUI 2011AA)
37231002 (SNOMED CT 2011_0131)
10025415 (MedDRA 14.1)
Blood donation within the last 30 days.
Item
Blood donation within the last 30 days.
boolean
C0005794 (UMLS CUI 2011AA)
25179006 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
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