ID

4359

Description

ODM derived from http://clinicaltrials.gov/show/NCT01206647

Lien

http://clinicaltrials.gov/show/NCT01206647

Mots-clés

Versions (3)
  1. 07/12/2013 07/12/2013 - Martin Dugas
  2. 19/04/2014 19/04/2014 - Julian Varghese
  3. 27/09/2021 27/09/2021 -
Téléchargé le

7 décembre 2013

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01206647 Diabetes Mellitus, Type 2

Allemand Anglais

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 80 Years
Description

age 18 Years to 80 Years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diabetes Mellitus, Type 2
Description

Diabetes Mellitus, Type 2

Type de données

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
Combination of OAD and basal insulin treatment (BOT) or intensified conventional therapy (ICT, > 2 injections of basal and prandial) or conventional insulin therapy (CIT, 1 or 2 injections of basal or biphasic)
Description

Combination of OAD and basal insulin treatment (BOT) or intensified conventional therapy (ICT, > 2 injections of basal and prandial) or conventional insulin therapy (CIT, 1 or 2 injections of basal or biphasic)

Type de données

boolean

Alias
UMLS CUI 2011AA
C1947911
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
C0650607
SNOMED CT 2011_0131
416303005
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0522510
SNOMED CT 2011_0131
103370009
UMLS CUI 2011AA
C0439858
SNOMED CT 2011_0131
255333006
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0439858
SNOMED CT 2011_0131
255333006
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
C0039798
Hemoglobin A1c (HbA1c)
Description

HbA1c < 7.5 %

Type de données

boolean

Alias
UMLS CUI 2011AA
C0019018
SNOMED CT 2011_0131
33601001
LOINC Version 232
MTHU018890
History of - insulin therapy
Description

Duration of insulin therapy > 1 year

Type de données

boolean

Alias
UMLS CUI 2011AA
C0455628
SNOMED CT 2011_0131
161649006
Insulin dose < 120 IU/day
Description

Insulin dose < 120 IU/day

Type de données

boolean

Alias
UMLS CUI 2011AA
C0021641
SNOMED CT 2011_0131
67866001
LOINC Version 232
MTHU019392
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0439453
SNOMED CT 2011_0131
258997004
UMLS CUI 2011AA
C0439505
SNOMED CT 2011_0131
259032004
Fasting C-peptide > 0.6 ng/l
Description

Fasting C-peptide > 0.6 ng/l

Type de données

boolean

Alias
UMLS CUI 2011AA
C1550565
HL7 V3 2006_05
FAST
UMLS CUI 2011AA
C0006558
SNOMED CT 2011_0131
39973008
LOINC Version 232
MTHU003747
Elevated fasting glucose
Description

Fasting glucose <= 210 mg/dl

Type de données

boolean

Alias
UMLS CUI 2011AA
C1260439
ICD-10-CM Version 2010
R73.01
Full legal, mental and physical ability to give informed consent
Description

Full legal, mental and physical ability to give informed consent

Type de données

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
Patient consent that the general physician will be informed of trail participation
Description

Patient consent that the general physician will be informed of trail participation

Type de données

boolean

Alias
UMLS CUI 2011AA
C1511481
LOINC Version 232
MTHU035862
UMLS CUI 2011AA
C0033131, C0017319
SNOMED CT 2011_0131
446050000, 59058001
UMLS CUI 2011AA
C1522154
UMLS CUI 2011AA
C2348568
Experience in self measurement of blood glucose > 1 year
Description

Experience in self measurement of blood glucose > 1 year

Type de données

boolean

Alias
UMLS CUI 2011AA
C0596545
UMLS CUI 2011AA
C0005803
SNOMED CT 2011_0131
308113006
Exclusion Criteria
Description

Exclusion Criteria

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

Type 1 Diabetes mellitus

Type de données

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
History of drug or alcohol abuse within the last five years prior to screening
Description

History of drug or alcohol abuse within the last five years prior to screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C1299544
SNOMED CT 2011_0131
371435006
UMLS CUI 2011AA
C0221628
SNOMED CT 2011_0131
371434005
History of severe or multiple allergies
Description

History of severe or multiple allergies

Type de données

boolean

Alias
UMLS CUI 2011AA
C0489531
LOINC Version 232
MTHU001065
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0439064
SNOMED CT 2011_0131
255204007
Progressive fatal disease
Description

Progressive fatal disease

Type de données

boolean

Alias
UMLS CUI 2011AA
C1302234
SNOMED CT 2011_0131
399166001
UMLS CUI 2011AA
C1335499
History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), neurological, psychiatric and/or haematological disease as judged by the investigator
Description

History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), neurological, psychiatric and/or haematological disease as judged by the investigator

Type de données

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
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
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
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
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
Renal insufficiency or history of significant renal diseases (creatinine clearance < 60 ml/min determined using the Cockroft-Goult equation).
Description

Renal insufficiency or history of significant renal diseases (creatinine clearance < 60 ml/min determined using the Cockroft-Goult equation).

Type de données

boolean

Alias
UMLS CUI 2011AA
C1565489
MedDRA 14.1
10038474
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C2711451
SNOMED CT 2011_0131
442407001
Contra-indications for study drugs including contraindications for the rescue drugs
Description

Contra-indications for study drugs including contraindications for the rescue drugs

Type de données

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0175673
SNOMED CT 2011_0131
25876001
UMLS CUI 2011AA
C0013227
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

Type de données

boolean

Alias
UMLS CUI 2011AA
C0021055
SNOMED CT 2011_0131
940000
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C2348205
UMLS CUI 2011AA
C0220807
Pregnancy or breast feeding
Description

Pregnancy or breast feeding

Type de données

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
Description

Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner

Type de données

boolean

Alias
UMLS CUI 2011AA
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0420844
SNOMED CT 2011_0131
169450001
UMLS CUI 2011AA
CL424925
UMLS CUI 2011AA
C1262153
MedDRA 14.1
10062577
UMLS CUI 2011AA
C0457572
SNOMED CT 2011_0131
268458002
UMLS CUI 2011AA
C3164761
SNOMED CT 2011_0131
449038007
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
Treatment with any other investigational drug within 3 months prior to screening
Description

Treatment with any other investigational drug within 3 months prior to screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
Description

Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study

Type de données

boolean

Alias
UMLS CUI 2011AA
C0457432
SNOMED CT 2011_0131
258143003
UMLS CUI 2011AA
C2348205
UMLS CUI 2011AA
C0392360
SNOMED CT 2011_0131
410666004 230165009
LOINC Version 232
MTHU008862
UMLS CUI 2011AA
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C1272703
SNOMED CT 2011_0131
385669000
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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Similar models

Eligibility

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 80 Years
Item
age 18 Years to 80 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diabetes Mellitus, Type 2
Item
Diabetes Mellitus, Type 2
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)
Combination of OAD and basal insulin treatment (BOT) or intensified conventional therapy (ICT, > 2 injections of basal and prandial) or conventional insulin therapy (CIT, 1 or 2 injections of basal or biphasic)
Item
Combination of OAD and basal insulin treatment (BOT) or intensified conventional therapy (ICT, > 2 injections of basal and prandial) or conventional insulin therapy (CIT, 1 or 2 injections of basal or biphasic)
boolean
C1947911 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0935929 (UMLS CUI 2011AA)
373245004 (SNOMED CT 2011_0131)
C0650607 (UMLS CUI 2011AA)
416303005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0439858 (UMLS CUI 2011AA)
255333006 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0439858 (UMLS CUI 2011AA)
255333006 (SNOMED CT 2011_0131)
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
HbA1c < 7.5 %
Item
Hemoglobin A1c (HbA1c)
boolean
C0019018 (UMLS CUI 2011AA)
33601001 (SNOMED CT 2011_0131)
MTHU018890 (LOINC Version 232)
Duration of insulin therapy > 1 year
Item
History of - insulin therapy
boolean
C0455628 (UMLS CUI 2011AA)
161649006 (SNOMED CT 2011_0131)
Insulin dose < 120 IU/day
Item
Insulin dose < 120 IU/day
boolean
C0021641 (UMLS CUI 2011AA)
67866001 (SNOMED CT 2011_0131)
MTHU019392 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0439453 (UMLS CUI 2011AA)
258997004 (SNOMED CT 2011_0131)
C0439505 (UMLS CUI 2011AA)
259032004 (SNOMED CT 2011_0131)
Fasting C-peptide > 0.6 ng/l
Item
Fasting C-peptide > 0.6 ng/l
boolean
C1550565 (UMLS CUI 2011AA)
FAST (HL7 V3 2006_05)
C0006558 (UMLS CUI 2011AA)
39973008 (SNOMED CT 2011_0131)
MTHU003747 (LOINC Version 232)
Fasting glucose <= 210 mg/dl
Item
Elevated fasting glucose
boolean
C1260439 (UMLS CUI 2011AA)
R73.01 (ICD-10-CM Version 2010)
Full legal, mental and physical ability to give informed consent
Item
Full legal, mental and physical ability to give informed consent
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
Patient consent that the general physician will be informed of trail participation
Item
Patient consent that the general physician will be informed of trail participation
boolean
C1511481 (UMLS CUI 2011AA)
MTHU035862 (LOINC Version 232)
C0033131, C0017319 (UMLS CUI 2011AA)
446050000, 59058001 (SNOMED CT 2011_0131)
C1522154 (UMLS CUI 2011AA)
C2348568 (UMLS CUI 2011AA)
Experience in self measurement of blood glucose > 1 year
Item
Experience in self measurement of blood glucose > 1 year
boolean
C0596545 (UMLS CUI 2011AA)
C0005803 (UMLS CUI 2011AA)
308113006 (SNOMED CT 2011_0131)
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)
History of drug or alcohol abuse within the last five years prior to screening
Item
History of drug or alcohol abuse within the last five years prior to screening
boolean
C1299544 (UMLS CUI 2011AA)
371435006 (SNOMED CT 2011_0131)
C0221628 (UMLS CUI 2011AA)
371434005 (SNOMED CT 2011_0131)
History of severe or multiple allergies
Item
History of severe or multiple allergies
boolean
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
Progressive fatal disease
Item
Progressive fatal disease
boolean
C1302234 (UMLS CUI 2011AA)
399166001 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), neurological, psychiatric and/or haematological disease as judged by the investigator
Item
History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), neurological, psychiatric and/or haematological disease as judged by the investigator
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)
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)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
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)
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)
Renal insufficiency or history of significant renal diseases (creatinine clearance < 60 ml/min determined using the Cockroft-Goult equation).
Item
Renal insufficiency or history of significant renal diseases (creatinine clearance < 60 ml/min determined using the Cockroft-Goult equation).
boolean
C1565489 (UMLS CUI 2011AA)
10038474 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C2711451 (UMLS CUI 2011AA)
442407001 (SNOMED CT 2011_0131)
Contra-indications for study drugs including contraindications for the rescue drugs
Item
Contra-indications for study drugs including contraindications for the rescue drugs
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0175673 (UMLS CUI 2011AA)
25876001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
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
C0021055 (UMLS CUI 2011AA)
940000 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C2348205 (UMLS CUI 2011AA)
C0220807 (UMLS CUI 2011AA)
Pregnancy or breast feeding
Item
Pregnancy or breast feeding
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
Item
Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
boolean
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
CL424925 (UMLS CUI 2011AA)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0457572 (UMLS CUI 2011AA)
268458002 (SNOMED CT 2011_0131)
C3164761 (UMLS CUI 2011AA)
449038007 (SNOMED CT 2011_0131)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
Treatment with any other investigational drug within 3 months prior to screening
Item
Treatment with any other investigational drug within 3 months prior to screening
boolean
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
Item
Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
boolean
C0457432 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
C2348205 (UMLS CUI 2011AA)
C0392360 (UMLS CUI 2011AA)
410666004 230165009 (SNOMED CT 2011_0131)
MTHU008862 (LOINC Version 232)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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