ID

33474

Beschrijving

The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01975389

Link

https://clinicaltrials.gov/show/NCT01975389

Trefwoorden

  1. 10-12-18 10-12-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 december 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Cardiovascular Disease NCT01975389

Eligibility Cardiovascular Disease NCT01975389

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be on background lipid lowering treatment.
Beschrijving

Lipid-lowering therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0585943
must be at high risk of a cv event.
Beschrijving

High risk of Cardiovascular event

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C1320716
must have an ldl c >/=100 mg/dl (2.6 mmol/l) or non hdl c >/=130 mg/dl (3.4 mmol/l).
Beschrijving

Low density lipoprotein cholesterol measurement | High density lipoprotein cholesterol level

Datatype

boolean

Alias
UMLS CUI [1]
C0202117
UMLS CUI [2]
C0428471
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
an ldl c <100 mg/dl (2.6 mmol/l) or non hdl c <130 mg/dl (3.4 mmol/l).
Beschrijving

Low density lipoprotein cholesterol measurement | High density lipoprotein cholesterol level

Datatype

boolean

Alias
UMLS CUI [1]
C0202117
UMLS CUI [2]
C0428471
planned coronary (pci or cabg) or other arterial revascularization.
Beschrijving

Coronary revascularisation Planned | PCI Planned | CABG Planned | Revascularization Arterial Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0010055
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0581603
UMLS CUI [4,2]
C0221464
UMLS CUI [4,3]
C1301732
new york heart association class iv congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging.
Beschrijving

Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction Cardiac imaging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C1096014
chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by mdrd formula or with end state renal disease on dialysis.
Beschrijving

Chronic Kidney Insufficiency | Creatinine clearance measurement MDRD formula | Dependence on dialysis due to end stage renal disease

Datatype

boolean

Alias
UMLS CUI [1]
C0403447
UMLS CUI [2,1]
C0373595
UMLS CUI [2,2]
C3839656
UMLS CUI [3]
C1997375
history of hemorrhagic stroke.
Beschrijving

Hemorrhagic stroke

Datatype

boolean

Alias
UMLS CUI [1]
C0553692
prior exposure to bococizumab or other investigational pcsk9 inhibitor.
Beschrijving

Exposure to bococizumab | Exposure to PCSK9 Inhibitors Investigational

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C4043705
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C4051516
UMLS CUI [2,3]
C1517586

Similar models

Eligibility Cardiovascular Disease NCT01975389

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Lipid-lowering therapy
Item
must be on background lipid lowering treatment.
boolean
C0585943 (UMLS CUI [1])
High risk of Cardiovascular event
Item
must be at high risk of a cv event.
boolean
C0332167 (UMLS CUI [1,1])
C1320716 (UMLS CUI [1,2])
Low density lipoprotein cholesterol measurement | High density lipoprotein cholesterol level
Item
must have an ldl c >/=100 mg/dl (2.6 mmol/l) or non hdl c >/=130 mg/dl (3.4 mmol/l).
boolean
C0202117 (UMLS CUI [1])
C0428471 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Low density lipoprotein cholesterol measurement | High density lipoprotein cholesterol level
Item
an ldl c <100 mg/dl (2.6 mmol/l) or non hdl c <130 mg/dl (3.4 mmol/l).
boolean
C0202117 (UMLS CUI [1])
C0428471 (UMLS CUI [2])
Coronary revascularisation Planned | PCI Planned | CABG Planned | Revascularization Arterial Planned
Item
planned coronary (pci or cabg) or other arterial revascularization.
boolean
C0877341 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1532338 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0010055 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0581603 (UMLS CUI [4,1])
C0221464 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction Cardiac imaging
Item
new york heart association class iv congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C1096014 (UMLS CUI [2,2])
Chronic Kidney Insufficiency | Creatinine clearance measurement MDRD formula | Dependence on dialysis due to end stage renal disease
Item
chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by mdrd formula or with end state renal disease on dialysis.
boolean
C0403447 (UMLS CUI [1])
C0373595 (UMLS CUI [2,1])
C3839656 (UMLS CUI [2,2])
C1997375 (UMLS CUI [3])
Hemorrhagic stroke
Item
history of hemorrhagic stroke.
boolean
C0553692 (UMLS CUI [1])
Exposure to bococizumab | Exposure to PCSK9 Inhibitors Investigational
Item
prior exposure to bococizumab or other investigational pcsk9 inhibitor.
boolean
C0332157 (UMLS CUI [1,1])
C4043705 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C4051516 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])

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