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ID
22600
Beschrijving
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus
Trefwoorden
Versies (1)
- 08-06-17 08-06-17 -
Houder van rechten
Genentech, Inc.
Geüploaded op
8 juni 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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TARGETED MEDICAL HISTORY AND BASELINE CONDITIONS (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330
TARGETED MEDICAL HISTORY AND BASELINE CONDITIONS (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330
Similar models
TARGETED MEDICAL HISTORY AND BASELINE CONDITIONS (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
PT
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
PTINIT
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
VDT
Item
Report Date:
date
C1302584 (UMLS CUI [1,1])
Item Group
TARGETED MEDICAL HISTORY AND BASELINE CONDITIONS (SCREENING)
CL Item
Applanation tonometry (1)
CL Item
Non-contact tonometry (2)
CL Item
Tonopen (3)
CL Item
Pneumotonometry (4)
Glaucoma medical history
Item
No Known History
boolean
C0017601 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
glaucoma active
Item
Condition Currently Active?
boolean
C0017601 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
glaucoma onset date
Item
Onset Date
date
C0017601 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
glaucoma onset date unknown
Item
Date Unknown
boolean
C0017601 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
CL Item
Applanation tonometry (1)
CL Item
Non-contact tonometry (2)
CL Item
Tonopen (3)
CL Item
Pneumotonometry (4)
dry AMD medical history
Item
No Known History
boolean
C3888461 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
dry AMD active
Item
Condition Currently Active?
boolean
C3888461 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
dry AMD onset date
Item
Onset Date
date
C3888461 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
dry AMD onset date unknown
Item
Date Unknown
boolean
C3888461 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
wet AMD
Item
Wet AMD
text
C3888896 (UMLS CUI [1])
wet AMD active
Item
Condition Currently Active?
boolean
C3888896 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
wet AMD medical history
Item
No Known History
boolean
C3888896 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
wet AMD onset date
Item
Onset Date
date
C3888896 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
wet AMD onset date unknown
Item
Date Unknown
boolean
C3888896 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Hypertension
Item
Hypertension
boolean
C0020538 (UMLS CUI [1])
hypertension medical history
Item
No Known History
boolean
C0020538 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
hypertension active
Item
Condition Currently Active?
boolean
C0020538 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
hypertension onset date
Item
Onset Date
date
C0020538 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
hypertension onset date unknown
Item
Date Unknown
boolean
C0020538 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Angina
Item
Angina
boolean
C0002962 (UMLS CUI [1])
angina medical history
Item
No Known History
boolean
C0002962 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
angina active
Item
Condition Currently Active?
boolean
C0002962 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
angina onset date
Item
Onset Date
date
C0002962 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
angina onset date unknown
Item
Date Unknown
boolean
C0002962 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Myocardial Infarction
Item
Myocardial Infarction
boolean
C0027051 (UMLS CUI [1])
myocardial infarction medical history
Item
No Known History
boolean
C0027051 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
myocardial infarction active
Item
Condition Currently Active?
boolean
C0027051 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
myocardial infarction onset date
Item
Onset Date
date
C0027051 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
myocardial infacrction onset date unknown
Item
Date Unknown
boolean
C0027051 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Congestive Heart Failure
Item
Congestive Heart Failure
boolean
C0018802 (UMLS CUI [1])
congestive heart failure medical history
Item
No Known History
boolean
C0018802 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
congestive heart failure active
Item
Condition Currently Active?
boolean
C0018802 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
congestive heart failure onset date
Item
Onset Date
date
C0018802 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
congestive heart failure onset date unknown
Item
Date Unknown
boolean
C0018802 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Transient Ischemic Attack
Item
Transient Ischemic Attack
boolean
C0007787 (UMLS CUI [1])
Transient Ischemic Attack medical history
Item
No Known History
boolean
C0007787 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Transient Ischemic Attack active
Item
Condition Currently Active?
boolean
C0007787 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Transient Ischemic Attack onset date
Item
Onset Date
date
C0007787 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Transient Ischemic Attack onset date unknown
Item
Date Unknown
boolean
C0007787 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Cerebral Vascular Accident (Stroke)
Item
Cerebral Vascular Accident (Stroke)
boolean
C0038454 (UMLS CUI [1])
Cerebral Vascular Accident (Stroke) medical history
Item
No Known History
boolean
C0038454 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Cerebral Vascular Accident (Stroke) active
Item
Condition Currently Active?
boolean
C0038454 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Cerebral Vascular Accident (Stroke) onset date
Item
Onset Date
date
C0038454 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Cerebral Vascular Accident (Stroke) onset date unknown
Item
Date Unknown
boolean
C0038454 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Diabetes Mellitus
Item
Diabetes Mellitus
boolean
C0011849 (UMLS CUI [1])
Diabetes Mellitus medical history
Item
No Known History
boolean
C0011849 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Diabetes Mellitus active
Item
Condition Currently Active?
boolean
C0011849 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Diabetes Mellitus onset date
Item
Onset Date
date
C0011849 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Diabetes Mellitus onset date unknown
Item
Date Unknown
boolean
C0011849 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Prior Non-Ocular Hemorrhage
Item
Prior Non-Ocular Hemorrhage
boolean
C0019080 (UMLS CUI [1])
Prior Non-Ocular Hemorrhage medical history
Item
No Known History
boolean
C0019080 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Prior Non-Ocular Hemorrhage active
Item
Condition Currently Active?
boolean
C0019080 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Prior Non-Ocular Hemorrhage onset date
Item
Onset Date
date
C0019080 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Prior Non-Ocular Hemorrhage onset date unknown
Item
Date Unknown
boolean
C0019080 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Deep Venous Thrombosis
Item
Deep Venous Thrombosis
boolean
C0149871 (UMLS CUI [1])
dvt medical history
Item
No Known History
boolean
C0149871 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
dvt active
Item
Condition Currently Active?
boolean
C0149871 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
dvt onset date
Item
Onset Date
date
C0149871 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
dvt onset date unknown
Item
Date Unknown
boolean
C0149871 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Endarterectomy
Item
Endarterectomy
boolean
C0014098 (UMLS CUI [1])
Endarterectomy medical history
Item
No Known History
boolean
C0014098 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Endarterectomy active
Item
Condition Currently Active?
boolean
C0014098 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Endarterectomy onset date
Item
Onset Date
date
C0014098 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Endarterectomy onset date unknown
Item
Date Unknown
boolean
C0014098 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Renal Failure
Item
Renal Failure
boolean
C1533077 (UMLS CUI [1])
Renal Failure medical history
Item
No Known History
boolean
C1533077 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Renal Failure active
Item
Condition Currently Active?
boolean
C1533077 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Renal failure onset date
Item
Onset Date
date
C1533077 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Renal failure onset date unknown
Item
Date Unknown
boolean
C1533077 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Coronary Artery Bypass Surgery
Item
Coronary Artery Bypass Surgery
boolean
C0010055 (UMLS CUI [1])
Coronary Artery Bypass Surgery medical history
Item
No Known History
boolean
C0010055 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Coronary Artery Bypass Surgery active
Item
Condition Currently Active?
boolean
C0010055 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Coronary Artery Bypass Surgery onset date
Item
Onset Date
date
C0010055 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Coronary Artery Bypass Surgery onset date unknown
Item
Date Unknown
boolean
C0010055 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Coronary Stents
Item
Coronary Stents
boolean
C0687568 (UMLS CUI [1])
Coronary Stents medical history
Item
No Known History
boolean
C0687568 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Coronary Stents active
Item
Condition Currently Active?
boolean
C0687568 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Coronary Stents onset date
Item
Onset Date
date
C0687568 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Coronary Stents onset date unknown
Item
Date Unknown
boolean
C0687568 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Coronary Artery Disease (CAD)
Item
Coronary Artery Disease (CAD)
boolean
C1956346 (UMLS CUI [1])
cad active
Item
Condition Currently Active?
boolean
C1956346 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
cad medical history
Item
No Known History
boolean
C1956346 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
cad onset date
Item
Onset Date
date
C1956346 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
cad onset date unknown
Item
Date Unknown
boolean
C1956346 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Nose Bleeds
Item
Nose Bleeds
boolean
C0014591 (UMLS CUI [1])
Nose Bleeds active
Item
Condition Currently Active?
boolean
C0014591 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Nose Bleeds medical history
Item
No Known History
boolean
C0014591 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Nose Bleeds onset date
Item
Onset Date
date
C0014591 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Nose Bleeds onset date unknown
Item
Date Unknown
boolean
C0014591 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Arrhythmia
Item
Arrhythmia
boolean
C0003811 (UMLS CUI [1])
Arrhythmia active
Item
Condition Currently Active?
boolean
C0003811 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Arrhythmia medical history
Item
No Known History
boolean
C0003811 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Arrhythmia onset date
Item
Onset Date
date
C0003811 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Arrhythmia onset date unknown
Item
Date Unknown
boolean
C0003811 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Diverticular Disease
Item
Diverticular Disease
boolean
C1510475 (UMLS CUI [1])
diverticular disease medical history
Item
No Known History
boolean
C1510475 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Diverticular disease active
Item
Condition Currently Active?
boolean
C1510475 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Diverticular disease onset date
Item
Onset Date
date
C1510475 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Diverticular Disease onset date unknown
Item
Date Unknown
boolean
C1510475 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Proteinuria
Item
Proteinuria
boolean
C0033687 (UMLS CUI [1])
Proteinuria medical history
Item
No Known History
boolean
C0033687 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Proteinuria active
Item
Condition Currently Active?
boolean
C0033687 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Proteinuria onset date
Item
Onset Date
date
C0033687 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Proteinuria onset date unknown
Item
Date Unknown
boolean
C0033687 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Rheumatoid Arthritis
Item
Rheumatoid Arthritis
boolean
C0003873 (UMLS CUI [1])
Rheumatoid Arthritis medical history
Item
No Known History
boolean
C0003873 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Rheumatoid Arthritis active
Item
Condition Currently Active?
boolean
C0003873 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Rheumatoid Arthritis onset date
Item
Onset Date
date
C0003873 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Rheumatoid Arthritis onset date unknown
Item
Date Unknown
boolean
C0003873 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Dermatitis
Item
Dermatitis
boolean
C0011603 (UMLS CUI [1])
Dermatitis medical history
Item
No Known History
boolean
C0011603 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Dermatitis active
Item
Condition Currently Active?
boolean
C0011603 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C2707252 (UMLS CUI [1,2])
Dermatitis onset date
Item
Onset Date
date
C0011603 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Dermatitis onset date unknown
Item
Date Unknown
boolean
C0011603 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
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