ID

15032

Descrizione

Evaluation of Antiplatelet Effects and Safety of Intraoperative Administration of Ticagrelor Versus Clopidogrel; ODM derived from: https://clinicaltrials.gov/show/NCT02513004

collegamento

https://clinicaltrials.gov/show/NCT02513004

Keywords

versioni (1)
  1. 11/05/16 11/05/16 -
Caricato su

11 maggio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT02513004

Inglese

Eligibility Coronary Disease NCT02513004

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of informed consent prior to any study specific procedures
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
2. a patient who is considered as ethnic chinese
Descrizione

Ethnic group Chinese

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0152035
3. 80years >aged> 18years, male or female
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
4. patient is willing to perform hcr with the following conditions: multi-vessel coronary artery disease with unfavorable lad for pci (i.e., chronic total occlusion, excessive tortuosity, severely diffuse lesion), unprotected left main coronary artery disease, and non-lad lesions were technically feasible for pci with a drug-eluting stent (des) .limitations to traditional cabg, such as pre-existing organ dysfunction, heavily calcified proximal aorta, or lack of suitable graft conduits
Descrizione

Coronary revascularisation | Multi vessel coronary artery disease | Anterior descending branch of left coronary artery | Percutaneous Coronary Intervention | Chronic total occlusion of coronary artery | Arterial tortuosity | Diffuse Lesion | Left main coronary artery disease | Drug-Eluting Coronary Stents | Coronary Artery Bypass Surgery | Single organ dysfunction | Aorta; stenosis, calcified

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0877341
UMLS CUI [2]
C1299432
UMLS CUI [3]
C0226032
UMLS CUI [4]
C1532338
UMLS CUI [5]
C1955779
UMLS CUI [6]
C3279191
UMLS CUI [7]
C1707743
UMLS CUI [8]
C1299433
UMLS CUI [9]
C1262327
UMLS CUI [10]
C0010055
UMLS CUI [11]
C0349410
UMLS CUI [12]
C1388213
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. involvement in the planning and/or conduct of the study
Descrizione

Involvement with Clinical Trial

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0008976
2. previous enrolment or randomization in the present study
Descrizione

Enrollment in clinical trial Previous | Randomization Previous

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C4041024
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0205156
3. participation in another clinical study with an investigational product during the last 30 days
Descrizione

Study Subject Participation Status | Investigational New Drugs

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
4. contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, gi bleed within the past 6 months, major surgery within 30 days)
Descrizione

Clopidogrel contraindicated | Medical contraindication Ticagrelor | Hypersensitivity | Hemorrhage | Has Moderate or Severe Liver Disease | Intracranial Hemorrhages | Gastrointestinal Hemorrhage | Major surgery

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1319916
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1999375
UMLS CUI [3]
C0020517
UMLS CUI [4]
C0019080
UMLS CUI [5]
C3829821
UMLS CUI [6]
C0151699
UMLS CUI [7]
C0017181
UMLS CUI [8]
C0679637
5. with coagulation disorder
Descrizione

Blood Coagulation Disorders

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005779
6. with uric acid nephropathy
Descrizione

Uric acid nephropathy acute

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0859034
7. history of intolerance or allergy to asa or clopidogrel or ticagrelor
Descrizione

Intolerance Aspirin | Intolerance Clopidogrel | Intolerance Ticagrelor | Hypersensitivity Aspirin | Hypersensitivity clopidogrel | Hypersensitivity Ticagrelor

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C1999375
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0004057
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0070166
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C1999375
8. patient has a coronary artery bypass graft (cabg) history.
Descrizione

Coronary Artery Bypass Surgery

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0010055
9. left subclavian artery and lima stenosis
Descrizione

Stenosis of left subclavian artery | Left internal mammary artery Stenosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4047831
UMLS CUI [2,1]
C0447054
UMLS CUI [2,2]
C1261287
10. buried intramyocardial lad
Descrizione

Anterior descending branch of left coronary artery | Myocardium

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0226032
UMLS CUI [2]
C0027061
11. need for a concomitant operation (e.g., valve repair or replacement)
Descrizione

Needs Operative Surgical Procedures Simultaneous | Repair of heart valve | Heart valve replacement

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0027552
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0521115
UMLS CUI [2]
C0190112
UMLS CUI [3]
C0190173
12. overt congestive heart failure
Descrizione

Congestive heart failure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018802
13. unsuccessful lima-lad graft
Descrizione

Left internal mammary artery Anterior descending branch of left coronary artery Graft Unsuccessful

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0447054
UMLS CUI [1,2]
C0226032
UMLS CUI [1,3]
C0332835
UMLS CUI [1,4]
C1272705
14. hemodynamic instability
Descrizione

Hemodynamic instability

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0948268
15. other conditions rendering pci unsuitable (e.g., fresh thrombus, coronary vessel diameter <1.5 mm)
Descrizione

Percutaneous Coronary Intervention Patient unsuitable for procedure due to medical condition | Thrombus Fresh | Coronary Vessel Diameter

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C3839545
UMLS CUI [2,1]
C0087086
UMLS CUI [2,2]
C0443224
UMLS CUI [3,1]
C0010075
UMLS CUI [3,2]
C1301886
16. platelet count less than 100*10^9/l
Descrizione

Platelet Count measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032181
17. haemoglobin (hb) level less than 110g/l
Descrizione

Hemoglobin level

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019029
18. white blood cell count less than 4*10^12/l
Descrizione

White Blood Cell Count procedure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023508
19. recent (within 30 days of dosing) blood donation
Descrizione

Blood Donation Recent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332185
20. fibrinolytic therapy in the 24 hours prior to randomisation, or planned fibrinolytic treatment following randomisation (eg, for stemi or pulmonary embolism)
Descrizione

Thrombolytic Therapy | ST segment elevation myocardial infarction | Pulmonary Embolism

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0040044
UMLS CUI [2]
C1536220
UMLS CUI [3]
C0034065
21. p2y12 receptor inhibitor therapy in 7 days before hcr surgery.
Descrizione

P2Y12 Receptor Antagonists Therapeutic procedure

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2962193
UMLS CUI [1,2]
C0087111
22. nonselective non-steroidal anti-inflammatory drugs (nsaids) and prostacyclins (pgi2) therapy that cannot be stopped
Descrizione

Anti-Inflammatory Agents, Non-Steroidal | Prostaglandins I | Epoprostenol | Therapeutic procedure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2]
C0205911
UMLS CUI [3]
C0033567
UMLS CUI [4]
C0087111
23. increased risk of bradycardic events (eg, no pacemaker and known sick sinus syndrome, second degree av block, third degree av block or previous documented syncope suspected to be due to bradycardia).
Descrizione

At risk of bradycardia | Artificial cardiac pacemaker | Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block | Syncope Due to Bradycardia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3875145
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0037052
UMLS CUI [4]
C0264906
UMLS CUI [5]
C0151517
UMLS CUI [6,1]
C0039070
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C0428977
24. concomitant oral or intravenous therapy (see examples below) with strong cyp3a inhibitors, cyp3a substrates with narrow therapeutic indices, or strong cyp3a inducers within 14 days of study treatment or cannot be stopped for the course of the study.
Descrizione

Concomitant Therapy Oral Route of Drug administration | Concomitant Therapy Intravenous Route of Drug Administration | Cytochrome P-450 CYP3A Inhibitors | Cytochrome P-450 CYP3A Inducers

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1707479
UMLS CUI [2,2]
C1522726
UMLS CUI [3]
C3850056
UMLS CUI [4]
C3850044
strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, over 1 litre daily of grapefruit juice.
Descrizione

inhibitors | Ketoconazole | Itraconazole | voriconazole | telithromycin | Clarithromycin | Nefadar | Ritonavir | Saquinavir | Nelfinavir | Indinavir | Reyataz | GRAPEFRUIT JUICE

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0243077
UMLS CUI [2]
C0022625
UMLS CUI [3]
C0064113
UMLS CUI [4]
C0393080
UMLS CUI [5]
C0907410
UMLS CUI [6]
C0055856
UMLS CUI [7]
C1436233
UMLS CUI [8]
C0292818
UMLS CUI [9]
C0286738
UMLS CUI [10]
C0525005
UMLS CUI [11]
C0376637
UMLS CUI [12]
C1258207
UMLS CUI [13]
C0452456
substrates with narrow therapeutic index: cyclosporine, quinidine. strong inducers: rifampin/rifampicin, phenytoin, carbamazepine. the sponsor should be consulted for enrolment with any concomitant medicines which are suspected of undergoing strong drug-drug interaction
Descrizione

Substrate Narrow Therapeutic Index | Cyclosporine | Quinidine | Rifampin | Phenytoin | Carbamazepine

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3891814
UMLS CUI [1,2]
C3889681
UMLS CUI [2]
C0010592
UMLS CUI [3]
C0034414
UMLS CUI [4]
C0035608
UMLS CUI [5]
C0031507
UMLS CUI [6]
C0006949
25. any other condition which in the opinion of the investigator, may either put the patient at risk or influence the result of the study (e.g., cardiogenic shock or active cancer)
Descrizione

Comorbidity Affecting Patient safety Research results | Shock, Cardiogenic | Malignant Neoplasms

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [1,4]
C0683954
UMLS CUI [2]
C0036980
UMLS CUI [3]
C0006826
26. moderate or severe renal disease;
Descrizione

Has Moderate or Severe Renal Disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3829820
27. moderate or severe chronic lung disease or asthma;
Descrizione

Chronic lung disease Moderate | Severe chronic lung disease | Moderate asthma | Severe asthma

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0746102
UMLS CUI [1,2]
C0205081
UMLS CUI [2]
C3278799
UMLS CUI [3]
C0581125
UMLS CUI [4]
C0581126
28. pregnancy or lactation
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Coronary Disease NCT02513004

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Ethnic group Chinese
Item
2. a patient who is considered as ethnic chinese
boolean
C0015031 (UMLS CUI [1,1])
C0152035 (UMLS CUI [1,2])
Age
Item
3. 80years >aged> 18years, male or female
boolean
C0001779 (UMLS CUI [1])
Coronary revascularisation | Multi vessel coronary artery disease | Anterior descending branch of left coronary artery | Percutaneous Coronary Intervention | Chronic total occlusion of coronary artery | Arterial tortuosity | Diffuse Lesion | Left main coronary artery disease | Drug-Eluting Coronary Stents | Coronary Artery Bypass Surgery | Single organ dysfunction | Aorta; stenosis, calcified
Item
4. patient is willing to perform hcr with the following conditions: multi-vessel coronary artery disease with unfavorable lad for pci (i.e., chronic total occlusion, excessive tortuosity, severely diffuse lesion), unprotected left main coronary artery disease, and non-lad lesions were technically feasible for pci with a drug-eluting stent (des) .limitations to traditional cabg, such as pre-existing organ dysfunction, heavily calcified proximal aorta, or lack of suitable graft conduits
boolean
C0877341 (UMLS CUI [1])
C1299432 (UMLS CUI [2])
C0226032 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
C1955779 (UMLS CUI [5])
C3279191 (UMLS CUI [6])
C1707743 (UMLS CUI [7])
C1299433 (UMLS CUI [8])
C1262327 (UMLS CUI [9])
C0010055 (UMLS CUI [10])
C0349410 (UMLS CUI [11])
C1388213 (UMLS CUI [12])
Item Group
C0680251 (UMLS CUI)
Involvement with Clinical Trial
Item
1. involvement in the planning and/or conduct of the study
boolean
C1314939 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Enrollment in clinical trial Previous | Randomization Previous
Item
2. previous enrolment or randomization in the present study
boolean
C4041024 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0034656 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs
Item
3. participation in another clinical study with an investigational product during the last 30 days
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Clopidogrel contraindicated | Medical contraindication Ticagrelor | Hypersensitivity | Hemorrhage | Has Moderate or Severe Liver Disease | Intracranial Hemorrhages | Gastrointestinal Hemorrhage | Major surgery
Item
4. contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, gi bleed within the past 6 months, major surgery within 30 days)
boolean
C1319916 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C1999375 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3])
C0019080 (UMLS CUI [4])
C3829821 (UMLS CUI [5])
C0151699 (UMLS CUI [6])
C0017181 (UMLS CUI [7])
C0679637 (UMLS CUI [8])
Blood Coagulation Disorders
Item
5. with coagulation disorder
boolean
C0005779 (UMLS CUI [1])
Uric acid nephropathy acute
Item
6. with uric acid nephropathy
boolean
C0859034 (UMLS CUI [1])
Intolerance Aspirin | Intolerance Clopidogrel | Intolerance Ticagrelor | Hypersensitivity Aspirin | Hypersensitivity clopidogrel | Hypersensitivity Ticagrelor
Item
7. history of intolerance or allergy to asa or clopidogrel or ticagrelor
boolean
C1744706 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C1999375 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0004057 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0070166 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C1999375 (UMLS CUI [6,2])
Coronary Artery Bypass Surgery
Item
8. patient has a coronary artery bypass graft (cabg) history.
boolean
C0010055 (UMLS CUI [1])
Stenosis of left subclavian artery | Left internal mammary artery Stenosis
Item
9. left subclavian artery and lima stenosis
boolean
C4047831 (UMLS CUI [1])
C0447054 (UMLS CUI [2,1])
C1261287 (UMLS CUI [2,2])
Anterior descending branch of left coronary artery | Myocardium
Item
10. buried intramyocardial lad
boolean
C0226032 (UMLS CUI [1])
C0027061 (UMLS CUI [2])
Needs Operative Surgical Procedures Simultaneous | Repair of heart valve | Heart valve replacement
Item
11. need for a concomitant operation (e.g., valve repair or replacement)
boolean
C0027552 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0521115 (UMLS CUI [1,3])
C0190112 (UMLS CUI [2])
C0190173 (UMLS CUI [3])
Congestive heart failure
Item
12. overt congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Left internal mammary artery Anterior descending branch of left coronary artery Graft Unsuccessful
Item
13. unsuccessful lima-lad graft
boolean
C0447054 (UMLS CUI [1,1])
C0226032 (UMLS CUI [1,2])
C0332835 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
Hemodynamic instability
Item
14. hemodynamic instability
boolean
C0948268 (UMLS CUI [1])
Percutaneous Coronary Intervention Patient unsuitable for procedure due to medical condition | Thrombus Fresh | Coronary Vessel Diameter
Item
15. other conditions rendering pci unsuitable (e.g., fresh thrombus, coronary vessel diameter <1.5 mm)
boolean
C1532338 (UMLS CUI [1,1])
C3839545 (UMLS CUI [1,2])
C0087086 (UMLS CUI [2,1])
C0443224 (UMLS CUI [2,2])
C0010075 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
Platelet Count measurement
Item
16. platelet count less than 100*10^9/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin level
Item
17. haemoglobin (hb) level less than 110g/l
boolean
C0019029 (UMLS CUI [1])
White Blood Cell Count procedure
Item
18. white blood cell count less than 4*10^12/l
boolean
C0023508 (UMLS CUI [1])
Blood Donation Recent
Item
19. recent (within 30 days of dosing) blood donation
boolean
C0005794 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Thrombolytic Therapy | ST segment elevation myocardial infarction | Pulmonary Embolism
Item
20. fibrinolytic therapy in the 24 hours prior to randomisation, or planned fibrinolytic treatment following randomisation (eg, for stemi or pulmonary embolism)
boolean
C0040044 (UMLS CUI [1])
C1536220 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
P2Y12 Receptor Antagonists Therapeutic procedure
Item
21. p2y12 receptor inhibitor therapy in 7 days before hcr surgery.
boolean
C2962193 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Anti-Inflammatory Agents, Non-Steroidal | Prostaglandins I | Epoprostenol | Therapeutic procedure
Item
22. nonselective non-steroidal anti-inflammatory drugs (nsaids) and prostacyclins (pgi2) therapy that cannot be stopped
boolean
C0003211 (UMLS CUI [1])
C0205911 (UMLS CUI [2])
C0033567 (UMLS CUI [3])
C0087111 (UMLS CUI [4])
At risk of bradycardia | Artificial cardiac pacemaker | Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block | Syncope Due to Bradycardia
Item
23. increased risk of bradycardic events (eg, no pacemaker and known sick sinus syndrome, second degree av block, third degree av block or previous documented syncope suspected to be due to bradycardia).
boolean
C3875145 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
C0037052 (UMLS CUI [3])
C0264906 (UMLS CUI [4])
C0151517 (UMLS CUI [5])
C0039070 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0428977 (UMLS CUI [6,3])
Concomitant Therapy Oral Route of Drug administration | Concomitant Therapy Intravenous Route of Drug Administration | Cytochrome P-450 CYP3A Inhibitors | Cytochrome P-450 CYP3A Inducers
Item
24. concomitant oral or intravenous therapy (see examples below) with strong cyp3a inhibitors, cyp3a substrates with narrow therapeutic indices, or strong cyp3a inducers within 14 days of study treatment or cannot be stopped for the course of the study.
boolean
C1707479 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1707479 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C3850056 (UMLS CUI [3])
C3850044 (UMLS CUI [4])
inhibitors | Ketoconazole | Itraconazole | voriconazole | telithromycin | Clarithromycin | Nefadar | Ritonavir | Saquinavir | Nelfinavir | Indinavir | Reyataz | GRAPEFRUIT JUICE
Item
strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, over 1 litre daily of grapefruit juice.
boolean
C0243077 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0064113 (UMLS CUI [3])
C0393080 (UMLS CUI [4])
C0907410 (UMLS CUI [5])
C0055856 (UMLS CUI [6])
C1436233 (UMLS CUI [7])
C0292818 (UMLS CUI [8])
C0286738 (UMLS CUI [9])
C0525005 (UMLS CUI [10])
C0376637 (UMLS CUI [11])
C1258207 (UMLS CUI [12])
C0452456 (UMLS CUI [13])
Substrate Narrow Therapeutic Index | Cyclosporine | Quinidine | Rifampin | Phenytoin | Carbamazepine
Item
substrates with narrow therapeutic index: cyclosporine, quinidine. strong inducers: rifampin/rifampicin, phenytoin, carbamazepine. the sponsor should be consulted for enrolment with any concomitant medicines which are suspected of undergoing strong drug-drug interaction
boolean
C3891814 (UMLS CUI [1,1])
C3889681 (UMLS CUI [1,2])
C0010592 (UMLS CUI [2])
C0034414 (UMLS CUI [3])
C0035608 (UMLS CUI [4])
C0031507 (UMLS CUI [5])
C0006949 (UMLS CUI [6])
Comorbidity Affecting Patient safety Research results | Shock, Cardiogenic | Malignant Neoplasms
Item
25. any other condition which in the opinion of the investigator, may either put the patient at risk or influence the result of the study (e.g., cardiogenic shock or active cancer)
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0036980 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
Has Moderate or Severe Renal Disease
Item
26. moderate or severe renal disease;
boolean
C3829820 (UMLS CUI [1])
Chronic lung disease Moderate | Severe chronic lung disease | Moderate asthma | Severe asthma
Item
27. moderate or severe chronic lung disease or asthma;
boolean
C0746102 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3278799 (UMLS CUI [2])
C0581125 (UMLS CUI [3])
C0581126 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
28. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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