ID

36122

Beskrivning

Pleiotropic Effects of Azilsartan Medoxomil Over Insulin Resistance in Obese, Diabetic and Hypertensive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02235519

Länk

https://clinicaltrials.gov/show/NCT02235519

Nyckelord

Versioner (1)
  1. 2019-04-16 2019-04-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT02235519

Engelsk

Eligibility Hypertension NCT02235519

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent in accordance with good clinical practices and local legislations
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. age between ≥25 and ≤ 65 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. patients with hypertension stage 1 as defined by systolic blood pressure (sbp) ≥140 but <159 mmhg and diastolic blood pressure (dbp) ≥90 but < 99 mmhg at randomization
Beskrivning

Hypertensive disease Stage | Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1306673
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
4. ability to stop any current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
Beskrivning

Ability Discontinue Antihypertensive therapy | Risk Unacceptable Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0585941
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C1883420
UMLS CUI [2,3]
C0332197
5. bmi ≥25 and ≤35.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
6. patients with type 2 diabetes mellitus can participate and will be stratified before randomization. diagnosis can be established by clinical history, 75-g oral glucose tolerance test (ada criteria), or fasting glucose > 126 mg/dl.
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Medical History | Oral Glucose Tolerance Test | Glucose measurement, fasting

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0029161
UMLS CUI [4]
C0202045
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who are not surgically sterile, nursing, are pregnant or without any anticonceptive methods.
Beskrivning

Premenopausal | Female Sterilization Absent | Breast Feeding | Pregnancy | Gender Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0279752
UMLS CUI [2,1]
C0015787
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0032961
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
UMLS CUI [5,3]
C0332197
2. known hypersensitivity to the study drug
Beskrivning

Hypersensitivity Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
3. gastrointestinal surgery which might alter absorption, distribution, or drug metabolism.
Beskrivning

Gastrointestinal Surgical Procedure Changing Drug absorption | Gastrointestinal Surgical Procedure Changing Substance distribution | Gastrointestinal Surgical Procedure Changing Drug metabolism

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524722
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0524722
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C1378698
UMLS CUI [3,1]
C0524722
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0683140
4. history of angioedema related to ace inhibitors or angiotensin ii receptor blockers.
Beskrivning

Angioedema Relationship Angiotensin-Converting Enzyme Inhibitors | Angioedema Relationship Angiotensin II receptor antagonist

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002994
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0003015
UMLS CUI [2,1]
C0002994
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0521942
5. night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
Beskrivning

Night shift worker

Datatyp

boolean

Alias
UMLS CUI [1]
C0555008
6. known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma)
Beskrivning

Secondary hypertension | Secondary hypertension Suspected | Renal Artery Stenosis | Pheochromocytoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0035067
UMLS CUI [4]
C0031511
7. sbp≥160 mmhg and/or dbp ≥100 mmhg
Beskrivning

Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
8. renal dysfunction as defined by: serum creatinine >3.0 mg/dl (or >265 umol/l) and/or creatinine clearance <30 ml/min and/or other clinical markers of severe renal impairment.
Beskrivning

Renal dysfunction | Creatinine measurement, serum | Creatinine clearance measurement | Clinical Markers Renal Insufficiency Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
UMLS CUI [4,1]
C0008963
UMLS CUI [4,2]
C1565489
UMLS CUI [4,3]
C0205082
9. bilateral renal arterial stenosis, renal artery stenosis in a solitary functional kidney, post-renal transplant patients or patients with one kidney
Beskrivning

Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Functioning Solitary | Status post Kidney Transplantation | Patients Kidney Single

Datatyp

boolean

Alias
UMLS CUI [1]
C0856760
UMLS CUI [2,1]
C0035067
UMLS CUI [2,2]
C0022646
UMLS CUI [2,3]
C0542341
UMLS CUI [2,4]
C0205171
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0022671
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0022646
UMLS CUI [4,3]
C0205171
10. clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/l or >5.5 mmol/l, may be rechecked for suspected error in result)
Beskrivning

Hypokalemia | Hyperkalemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0020621
UMLS CUI [2]
C0020461
11. uncorrected sodium or volume depletion
Beskrivning

Hyponatremia uncorrected | Hypovolemia uncorrected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020625
UMLS CUI [1,2]
C4072785
UMLS CUI [2,1]
C0546884
UMLS CUI [2,2]
C4072785
12. primary aldosteronism.
Beskrivning

Primary aldosteronism

Datatyp

boolean

Alias
UMLS CUI [1]
C1384514
13. hereditary fructose intolerance
Beskrivning

Hereditary fructose intolerance

Datatyp

boolean

Alias
UMLS CUI [1]
C0016751
14. biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
Beskrivning

Biliary obstruction | Cholestasis | Hepatic Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0400979
UMLS CUI [2]
C0008370
UMLS CUI [3]
C1306571
15. congestive heart failure class iii-iv according to criteria fron the new york heart association.
Beskrivning

Congestive heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
16. clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
Beskrivning

Tachycardia, Ventricular | Atrial Fibrillation | Atrial Flutter | Cardiac Arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1]
C0042514
UMLS CUI [2]
C0004238
UMLS CUI [3]
C0004239
UMLS CUI [4]
C0003811
17. hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
Beskrivning

Hypertrophic Cardiomyopathy | Coronary Artery Disease Obstructive Severe | Aortic Valve Stenosis | Aortic Valve Stenosis Hemodynamic Relevant | Mitral Valve Stenosis Hemodynamic Relevant

Datatyp

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0549186
UMLS CUI [2,3]
C0205082
UMLS CUI [3]
C0003507
UMLS CUI [4,1]
C0003507
UMLS CUI [4,2]
C0019010
UMLS CUI [4,3]
C2347946
UMLS CUI [5,1]
C0026269
UMLS CUI [5,2]
C0019010
UMLS CUI [5,3]
C2347946
18. patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an glycosylated hemoglobin a1c >=10% or fasting glucose greater than 400 mg/dl.
Beskrivning

Unstable diabetes mellitus | Diabetic - poor control | Hemoglobin A1c measurement | Glucose measurement, fasting

Datatyp

boolean

Alias
UMLS CUI [1]
C0342302
UMLS CUI [2]
C0421258
UMLS CUI [3]
C0474680
UMLS CUI [4]
C0202045
19. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin-ii receptor antagonists
Beskrivning

Symptoms Angioedema | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0002994
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
20. history of drug or alcohol dependency within 6 months prior to signing the informed consent form
Beskrivning

Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
21. concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
Beskrivning

Pharmaceutical Preparations Affecting Blood Pressure | Exception Pharmaceutical Preparations allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005823
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0683607
22. any investigational drug therapy within 1 month of signing the informed consent
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
23. known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)
Beskrivning

Hypersensitivity Component Investigational New Drugs | Hypersensitivity Telmisartan | Hydrochlorothiazide allergy | Hypersensitivity Placebo

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0248719
UMLS CUI [3]
C0571898
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1696465
24. history of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in).
Beskrivning

Compliance behavior Lacking | Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
25. any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication
Beskrivning

Other medical condition Preventing Completion of clinical trial | Other medical condition Preventing Administration Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C1533734
UMLS CUI [2,4]
C0013230
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Similar models

Eligibility Hypertension NCT02235519

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written informed consent in accordance with good clinical practices and local legislations
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age between ≥25 and ≤ 65 years
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease Stage | Systolic Pressure | Diastolic blood pressure
Item
3. patients with hypertension stage 1 as defined by systolic blood pressure (sbp) ≥140 but <159 mmhg and diastolic blood pressure (dbp) ≥90 but < 99 mmhg at randomization
boolean
C0020538 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Ability Discontinue Antihypertensive therapy | Risk Unacceptable Absent
Item
4. ability to stop any current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
boolean
C0085732 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0585941 (UMLS CUI [1,3])
C0035647 (UMLS CUI [2,1])
C1883420 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Body mass index
Item
5. bmi ≥25 and ≤35.
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Medical History | Oral Glucose Tolerance Test | Glucose measurement, fasting
Item
6. patients with type 2 diabetes mellitus can participate and will be stratified before randomization. diagnosis can be established by clinical history, 75-g oral glucose tolerance test (ada criteria), or fasting glucose > 126 mg/dl.
boolean
C0011860 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0029161 (UMLS CUI [3])
C0202045 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Premenopausal | Female Sterilization Absent | Breast Feeding | Pregnancy | Gender Contraceptive methods Absent
Item
1. pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who are not surgically sterile, nursing, are pregnant or without any anticonceptive methods.
boolean
C0279752 (UMLS CUI [1])
C0015787 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Hypersensitivity Investigational New Drugs
Item
2. known hypersensitivity to the study drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Gastrointestinal Surgical Procedure Changing Drug absorption | Gastrointestinal Surgical Procedure Changing Substance distribution | Gastrointestinal Surgical Procedure Changing Drug metabolism
Item
3. gastrointestinal surgery which might alter absorption, distribution, or drug metabolism.
boolean
C0524722 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0524722 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1378698 (UMLS CUI [2,3])
C0524722 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
Angioedema Relationship Angiotensin-Converting Enzyme Inhibitors | Angioedema Relationship Angiotensin II receptor antagonist
Item
4. history of angioedema related to ace inhibitors or angiotensin ii receptor blockers.
boolean
C0002994 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0003015 (UMLS CUI [1,3])
C0002994 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0521942 (UMLS CUI [2,3])
Night shift worker
Item
5. night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
boolean
C0555008 (UMLS CUI [1])
Secondary hypertension | Secondary hypertension Suspected | Renal Artery Stenosis | Pheochromocytoma
Item
6. known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma)
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0035067 (UMLS CUI [3])
C0031511 (UMLS CUI [4])
Systolic Pressure | Diastolic blood pressure
Item
7. sbp≥160 mmhg and/or dbp ≥100 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Renal dysfunction | Creatinine measurement, serum | Creatinine clearance measurement | Clinical Markers Renal Insufficiency Severe
Item
8. renal dysfunction as defined by: serum creatinine >3.0 mg/dl (or >265 umol/l) and/or creatinine clearance <30 ml/min and/or other clinical markers of severe renal impairment.
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C0008963 (UMLS CUI [4,1])
C1565489 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Functioning Solitary | Status post Kidney Transplantation | Patients Kidney Single
Item
9. bilateral renal arterial stenosis, renal artery stenosis in a solitary functional kidney, post-renal transplant patients or patients with one kidney
boolean
C0856760 (UMLS CUI [1])
C0035067 (UMLS CUI [2,1])
C0022646 (UMLS CUI [2,2])
C0542341 (UMLS CUI [2,3])
C0205171 (UMLS CUI [2,4])
C0231290 (UMLS CUI [3,1])
C0022671 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C0022646 (UMLS CUI [4,2])
C0205171 (UMLS CUI [4,3])
Hypokalemia | Hyperkalemia
Item
10. clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/l or >5.5 mmol/l, may be rechecked for suspected error in result)
boolean
C0020621 (UMLS CUI [1])
C0020461 (UMLS CUI [2])
Hyponatremia uncorrected | Hypovolemia uncorrected
Item
11. uncorrected sodium or volume depletion
boolean
C0020625 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C0546884 (UMLS CUI [2,1])
C4072785 (UMLS CUI [2,2])
Primary aldosteronism
Item
12. primary aldosteronism.
boolean
C1384514 (UMLS CUI [1])
Hereditary fructose intolerance
Item
13. hereditary fructose intolerance
boolean
C0016751 (UMLS CUI [1])
Biliary obstruction | Cholestasis | Hepatic Insufficiency
Item
14. biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
boolean
C0400979 (UMLS CUI [1])
C0008370 (UMLS CUI [2])
C1306571 (UMLS CUI [3])
Congestive heart failure New York Heart Association Classification
Item
15. congestive heart failure class iii-iv according to criteria fron the new york heart association.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Tachycardia, Ventricular | Atrial Fibrillation | Atrial Flutter | Cardiac Arrhythmia
Item
16. clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
boolean
C0042514 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
C0004239 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
Hypertrophic Cardiomyopathy | Coronary Artery Disease Obstructive Severe | Aortic Valve Stenosis | Aortic Valve Stenosis Hemodynamic Relevant | Mitral Valve Stenosis Hemodynamic Relevant
Item
17. hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
boolean
C0007194 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0549186 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0003507 (UMLS CUI [3])
C0003507 (UMLS CUI [4,1])
C0019010 (UMLS CUI [4,2])
C2347946 (UMLS CUI [4,3])
C0026269 (UMLS CUI [5,1])
C0019010 (UMLS CUI [5,2])
C2347946 (UMLS CUI [5,3])
Unstable diabetes mellitus | Diabetic - poor control | Hemoglobin A1c measurement | Glucose measurement, fasting
Item
18. patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an glycosylated hemoglobin a1c >=10% or fasting glucose greater than 400 mg/dl.
boolean
C0342302 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
C0202045 (UMLS CUI [4])
Symptoms Angioedema | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
19. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin-ii receptor antagonists
boolean
C1457887 (UMLS CUI [1,1])
C0002994 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
Substance Dependence
Item
20. history of drug or alcohol dependency within 6 months prior to signing the informed consent form
boolean
C0038580 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Blood Pressure | Exception Pharmaceutical Preparations allowed
Item
21. concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Investigational New Drugs
Item
22. any investigational drug therapy within 1 month of signing the informed consent
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Component Investigational New Drugs | Hypersensitivity Telmisartan | Hydrochlorothiazide allergy | Hypersensitivity Placebo
Item
23. known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0248719 (UMLS CUI [2,2])
C0571898 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C1696465 (UMLS CUI [4,2])
Compliance behavior Lacking | Protocol Compliance Unable
Item
24. history of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in).
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Other medical condition Preventing Completion of clinical trial | Other medical condition Preventing Administration Investigational New Drugs
Item
25. any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1533734 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
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