ID
44181
Description
PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome
Keywords
Versions (3)
- 10/3/17 10/3/17 -
- 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
- 9/20/21 9/20/21 -
Copyright Holder
glaxoSmithKline
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY-NC 3.0
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PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
age and child-bearing potential contraception
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1960468
- UMLS CUI [1,3]
- C0700589
Description
idiopathic Parkinson's disease Hoehn&Yahr Stage
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0865475
- UMLS CUI [1,2]
- C3639483
Description
study subject participation status ropinirole or candidate for dopaminergic therapy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0244821
- UMLS CUI [2]
- C3267134
Description
bmi
Data type
boolean
Alias
- UMLS CUI [1]
- C1305855
Description
informed consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
drug dosing ropinirole
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0244821
- UMLS CUI [1,2]
- C0678766
Description
exemption approved
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0585836
- UMLS CUI [1,2]
- C1708968
Description
Medical monitor name
Data type
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Description
Date of approval
Data type
date
Alias
- UMLS CUI [1]
- C2346844
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
physical examination abnormality
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0035648
Description
psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy
Data type
boolean
Alias
- UMLS CUI [1]
- C0004936
- UMLS CUI [2]
- C0018939
- UMLS CUI [3]
- C0022658
- UMLS CUI [4]
- C0023895
- UMLS CUI [5,1]
- C0014130
- UMLS CUI [5,2]
- C0027765
- UMLS CUI [6]
- C0007222
- UMLS CUI [7]
- C0006826
Description
laboratory abnormality or ECG abnormalities
Data type
boolean
Alias
- UMLS CUI [1]
- C0438215
- UMLS CUI [2]
- C0522055
Description
Hepatitis B surface antigen, Hepatitis C antibody and HIV antibody
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C0166049
- UMLS CUI [2]
- C0019683
Description
alcohol breath test or blood test and/or urine drugs of abuse test at screening
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0202306
- UMLS CUI [1,2]
- C1710477
- UMLS CUI [1,3]
- C1167994
- UMLS CUI [1,4]
- C1710477
- UMLS CUI [2,1]
- C0451130
- UMLS CUI [2,2]
- C1710477
Description
syncope or orthostatic hypotension
Data type
boolean
Alias
- UMLS CUI [1]
- C0020651
- UMLS CUI [2,1]
- C0039070
- UMLS CUI [2,2]
- C0262926
Description
sleep disorder or Epworth Sleep Score 39
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0851578
- UMLS CUI [1,2]
- C2129304
Description
Abnormal diastolic arterial pressure or abnormal systolic arterial pressure
Data type
boolean
Alias
- UMLS CUI [1]
- C0277888
- UMLS CUI [2]
- C0277883
Description
L-dopa treatment must be discontinued for at least a 2-week wash-out period prior to dosing with study medication
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0023570
Description
Note: Patients on dopaminergic agonists other than ropinirole CR may be enrolled if the agent is stopped for a 2-week wash-out period prior to enrolment. Patients on selegiline, amantadine, or anticholinergics may be enrolled but must have been on a stable dose for at least one month prior to study enrolment and must remain on their current dose throughout the treatment phase of the study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013036
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0262926
Description
hormone replacement therapy or CYP1A2 inhibitors or inducers
Data type
boolean
Alias
- UMLS CUI [1]
- C3850050
- UMLS CUI [2]
- C3850068
- UMLS CUI [3]
- C0282402
Description
Blood donation or significant blood loss
Data type
boolean
Alias
- UMLS CUI [1]
- C0005795
- UMLS CUI [2]
- C3163616
Description
personal history, or family history, of adverse reactions or hypersensitivity to ropinirole
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0244821
- UMLS CUI [1,3]
- C0241889
- UMLS CUI [1,4]
- C0559546
- UMLS CUI [1,5]
- C0244821
- UMLS CUI [1,6]
- C0241889
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C0244821
- UMLS CUI [2,3]
- C0332119
- UMLS CUI [3,1]
- C0559546
- UMLS CUI [3,2]
- C0244821
- UMLS CUI [3,3]
- C0332119
Description
Use of any investigational drug
Data type
boolean
Alias
- UMLS CUI [1]
- C0013230
Description
over-the-counter (OTC) medicine
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2709201
- UMLS CUI [1,2]
- C0013227
Description
With alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women. One unit is equivalent to half a pint of beer, one measure of spirits, or one glass of wine.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1510472
- UMLS CUI [1,2]
- C0085762
Description
drop out of the study prematurely or requirement of prohibited concomitant medication or non compliant behaviour
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348568
- UMLS CUI [1,3]
- C1321605
Description
pregnant or breast-feeding
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Description
exemption approved
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0585836
- UMLS CUI [1,2]
- C1708968
Description
Medical monitor name
Data type
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Description
Date of approval
Data type
date
Alias
- UMLS CUI [1]
- C2346844
Description
Physical examination
Alias
- UMLS CUI-1
- C0031809
Description
Body system
Data type
integer
Alias
- UMLS CUI [1,1]
- C1268086
- UMLS CUI [1,2]
- C0449913
Description
Body system abnormality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0460002
- UMLS CUI [1,2]
- C1704258
Description
Describe abnormality body system
Data type
text
Alias
- UMLS CUI [1,1]
- C0459424
- UMLS CUI [1,2]
- C0031809
- UMLS CUI [1,3]
- C0678257
Description
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Description
pregnancy test
Data type
integer
Alias
- UMLS CUI [1]
- C0032976
Description
pregnancy test
Data type
integer
Alias
- UMLS CUI [1]
- C0032976
Description
Date of pregnancy test
Data type
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Description
Result of pregnancy test
Data type
integer
Alias
- UMLS CUI [1]
- C0427777
Description
Alcohol breath/ blood test
Alias
- UMLS CUI-1
- C0202304
Description
Perform Alcohol Breath/Blood Test and attach printout
Data type
time
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C0040223
Description
Result of alcohol test
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C1274040
Description
alcohol consumption
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0443288
Description
Drug screening (urine)
Alias
- UMLS CUI-1
- C0202274
Description
Time of drug screening
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0202274
Description
Cannabinoids urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0006864
Description
Morphine and morphine derivates urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0279996
Description
Amphetamine urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0002667
Description
Barbiturates urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0004745
Description
Benzodiazepines urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0005064
Description
Cocaine urine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0009170
Description
Tricyclic antidepressants urine
Data type
integer
Alias
- UMLS CUI [1]
- C0003290
Description
Urine drug screening positive specify
Data type
text
Alias
- UMLS CUI [1,1]
- C2711519
- UMLS CUI [1,2]
- C1521902
Description
Orthostatic blood pressure / Pulse - Predose
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1095971
- UMLS CUI-3
- C0232117
- UMLS CUI-4
- C3812758
Description
For the pre-dose measurements in Part A, Day 1 of Periods 1 and 2, and Part B, Day 1 of Periods 1 and 2, 3 sets of semi-supine and erect blood pressure and pulse measurements will be taken, commencing approximately 40 minutes prior to dosing and each set will be separated by 10 minutes rest in the semi- supine position. Three stable measurements should be recorded In this instance stable is defined as the three semi-supine diastolic measurements being within 15 mmHg of the lowest measurement. This rule also applies for the semi-supine systolic and erect systolic and diastolic measurements. A maximum of six attempts can be made to obtain measurements pre-dose. If three consecutive stable measurements of blood pressure cannot be obtained then the Investigator should contact the Medical Monitor to discuss whether the patient can be included/continue in the study.
Data type
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C3812758
Description
Heart rate Semi-Supine
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Description
Heart Rate standing
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1,1]
- C2029905
- UMLS CUI [1,2]
- C3812758
Description
Systolic blood pressure semi-supine
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Description
Diastolic blood pressure semi-supine
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C3812758
Description
Systolic blood pressure standing
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C3812758
Description
Diastolic blood pressure standing
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C1303019
- UMLS CUI [1,2]
- C3812758
Description
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Description
If 'Yes', please document on the Concomitant Medication Report Forms.
Data type
integer
Alias
- UMLS CUI [1]
- C0580105
Description
tobacco use unchanged
Data type
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0442739
Description
dietary restrictions
Data type
integer
Alias
- UMLS CUI [1,1]
- C0425422
- UMLS CUI [1,2]
- C1321605
Description
Adverse event
Alias
- UMLS CUI-1
- C0877248
Description
Patient diary
Alias
- UMLS CUI-1
- C3890583
Description
Patient diary
Data type
text
Alias
- UMLS CUI [1]
- C3890583
Description
Randomization
Alias
- UMLS CUI-1
- C0034656
Description
study subject participation status eligibility
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013893
Description
Randomization
Data type
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C1522541
Description
High fat breakfast
Alias
- UMLS CUI-1
- C2698559
- UMLS CUI-2
- C0521974
Description
High fat breakfast started
Data type
time
Alias
- UMLS CUI [1,1]
- C2698559
- UMLS CUI [1,2]
- C0521974
- UMLS CUI [1,3]
- C0439659
Description
The suggested time for breakfast is 20 minutes
Data type
time
Alias
- UMLS CUI [1,1]
- C2698559
- UMLS CUI [1,2]
- C0521974
- UMLS CUI [1,3]
- C0444930
Description
Breakfast completed
Data type
integer
Alias
- UMLS CUI [1,1]
- C0814440
- UMLS CUI [1,2]
- C0205197
Description
Breakfast not completed comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0814440
- UMLS CUI [1,3]
- C0205197
Description
Study Drug Dosing
Alias
- UMLS CUI-1
- C0013175
- UMLS CUI-2
- C0678766
Description
The subject will not be allowed to lie down or sleep for 4 hours after the morning dose
Data type
time
Measurement units
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Description
Witness 1
Data type
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Description
Witness date 1
Data type
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Description
Witness 2
Data type
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Description
Witness date 2
Data type
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Description
Orthostatic blood pressure / pulse measurement - post dose
Alias
- UMLS CUI-1
- C1095971
- UMLS CUI-2
- C0232117
- UMLS CUI-3
- C0439568
Description
Date of visit
Data type
date
Alias
- UMLS CUI [1]
- C1320303
Description
Post dose
Data type
integer
Alias
- UMLS CUI [1]
- C0439568
Description
Time post dose
Data type
time
Alias
- UMLS CUI [1,1]
- C0439568
- UMLS CUI [1,2]
- C0040223
Description
Heart rate Semi-Supine
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Description
Heart Rate standing
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1,1]
- C2029905
- UMLS CUI [1,2]
- C0439568
Description
Systolic blood pressure semi-supine
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Description
Diastolic blood pressure semi-supine
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
- UMLS CUI [1,3]
- C0439568
Description
Systolic blood pressure standing
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C0439568
Description
Diastolic blood pressure standing
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [1,3]
- C0439568
Description
Adverse Event - post dosing
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Description
If Yes , please document on the Adverse Event Report Forms
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0439574
Description
If Yes , please document on the Adverse Event Report Forms
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1439442
Description
If Yes , please document on the Adverse Event Report Forms
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1439477
Description
Pharmacokinetic sampling post dosing
Alias
- UMLS CUI-1
- C0031328
Description
Sample ID and specified time
Data type
integer
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C1444698
Description
Actual time pharmacokinetics
Data type
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0040223
Description
Date sample
Data type
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C1302413
Description
Discharge
Alias
- UMLS CUI-1
- C0030685
Description
Discharge Time
Data type
time
Alias
- UMLS CUI [1]
- C3864299
Description
Advise the subject to refrain from consuming xanthine containing beverages and foods (Coffee, tea, cola beverages, cocoa chocolate), grapefruit containing products, quinine - containing products and food containing CYP1A2-inducing constituents (Brussel sprouts, broccoli, cabbage, etc ), from 24 h before the PK evaluation day, Periods 1 and 2 in Part B, until completion of assessments 24 h afterwards
Data type
date
Alias
- UMLS CUI [1]
- C1545257
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PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
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C1710477 (UMLS CUI [1,4])
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C0262926 (UMLS CUI [2,2])
C2129304 (UMLS CUI [1,2])
C0277883 (UMLS CUI [2])
C0023570 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C3850068 (UMLS CUI [2])
C0282402 (UMLS CUI [3])
C3163616 (UMLS CUI [2])
C0244821 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C0559546 (UMLS CUI [1,4])
C0244821 (UMLS CUI [1,5])
C0241889 (UMLS CUI [1,6])
C0020517 (UMLS CUI [2,1])
C0244821 (UMLS CUI [2,2])
C0332119 (UMLS CUI [2,3])
C0559546 (UMLS CUI [3,1])
C0244821 (UMLS CUI [3,2])
C0332119 (UMLS CUI [3,3])
C0013227 (UMLS CUI [1,2])
C0085762 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0006147 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,2])
C0202274 (UMLS CUI [1,2])
C0279996 (UMLS CUI [1,2])
C0005064 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1095971 (UMLS CUI-2)
C0232117 (UMLS CUI-3)
C3812758 (UMLS CUI-4)
C3812758 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
C3812758 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
C0231472 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
C3812758 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
C0013893 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C0521974 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0521974 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,2])
C0814440 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0001555 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0001555 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0232117 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
C0040223 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C0439568 (UMLS CUI-2)
C0439574 (UMLS CUI [1,2])
C1439442 (UMLS CUI [1,2])
C1439477 (UMLS CUI [1,2])
C1444698 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])