ID
41666
Beschrijving
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive
Trefwoorden
Versies (1)
- 07-12-20 07-12-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
7 december 2020
DOI
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Licentie
Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673
Logs and Repeats - Adverse Event/ Concomitant Medication/ Repeat Assessment Check Question; Non-Serious Adverse Events; Serious Adverse Events
Beschrijving
Adverse Event/ Concomitant Medication/ Repeat Assessment Check Questions
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0205341
- UMLS CUI-4
- C0220825
Beschrijving
Were any concomitant medications taken by the subject during the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0347984
Beschrijving
Did the subject experience any non-serious adverse events during the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0347984
Beschrijving
Did the subject experience any serious adverse event during the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0347984
Beschrijving
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0522055
Beschrijving
Were any repeat haematology or clinical chemistry samples taken?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0018941
- UMLS CUI [2,2]
- C0200345
Beschrijving
Were any repeat ECGs performed?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beschrijving
Were any repeat vital signs recorded?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Beschrijving
Were any repeat PK blood samples taken?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0205341
Beschrijving
Were any repeat Pulmonary Function Tests performed?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0205341
Beschrijving
Was any repeat Holter monitoring performed?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0205341
Beschrijving
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Non-Serious Adverse Event Sequence Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatype
text
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Non-Serious Adverse Event - Modified term
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2826798
Beschrijving
Non-Serious Adverse Event MedDRA synonym
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1140263
Beschrijving
Non-Serious Adverse Event MedDRA lower level term code
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C3898442
Beschrijving
Non-Serious Adverse Event - Failed coding
Datatype
text
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0805701
- UMLS CUI [2,2]
- C0231175
Beschrijving
Non-Serious Adverse Event - Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Beschrijving
Non-Serious Adverse Event - Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Beschrijving
Non-Serious Adverse Event Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschrijving
Non-Serious Adverse Event End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beschrijving
Non-Serious Adverse Event - End Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Beschrijving
Non-Serious Adverse Event Frequency
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beschrijving
Non-Serious Adverse Event - Maximum Intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschrijving
Non-Serious Adverse Event - Maximum Grade
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beschrijving
Non-Serious Adverse Event - Maximum Grade or Intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0518690
- UMLS CUI [1,4]
- C0806909
Beschrijving
Action Taken with Investigational Product(s) as a Result of the AE
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beschrijving
Did the subject withdraw from study as a result of this AE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beschrijving
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
Duration of AE if < 24 hours
Datatype
integer
Maateenheden
- h
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Beschrijving
Duration of AE if < 24 hours
Datatype
integer
Maateenheden
- min
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Beschrijving
Serious Adverse Event - Type of Report
Alias
- UMLS CUI-1
- C3897642
- UMLS CUI-2
- C0332307
Beschrijving
Serious Adverse Event - Randomisation
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0034656
Beschrijving
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschrijving
SAE Sequence Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Serious Adverse Event - Modified Term
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826798
Beschrijving
Serious Adverse Event - MedDRA synonym
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Beschrijving
Serious Adverse Event - MedDRA lower level term code
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898442
Beschrijving
Serious Adverse Event - Failed coding
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Beschrijving
Serious Adverse Event - Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Beschrijving
Serious Adverse Event - Start Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Beschrijving
Serious Adverse Event - Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschrijving
Serious Adverse Event - End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Beschrijving
Serious Adverse Event - End Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Beschrijving
Serious Adverse Event - Maximum Intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschrijving
Serious Adverse Event - Maximum Grade
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beschrijving
Serious Adverse Event - Maximum Grade or Intensity
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0518690
- UMLS CUI [1,4]
- C0806909
Beschrijving
Action Taken with Investigational Product(s) as a Result of the SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschrijving
Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschrijving
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
Duration of SAE if < 24 hours
Datatype
integer
Maateenheden
- h
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Beschrijving
Duration of SAE if < 24 hours
Datatype
integer
Maateenheden
- min
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Beschrijving
Was SAE caused by activities related to study participation (e.g. procedures)?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Beschrijving
Was the event serious?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Serious Adverse Event - Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beschrijving
Serious Adverse Event - Relevant Concomitant/ Treatment Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C2347946
- UMLS CUI-4
- C0304229
Beschrijving
CM Sequence Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant medication - Drug name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant medication dose
Datatype
float
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant medication unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519795
Beschrijving
Concomitant medication frequency
Datatype
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Beschrijving
Medication Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Beschrijving
Concomitant medication start date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Concomitant Medication continuing?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
If concomitant medication is not ongoing, specify end date.
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Concomitant medication - Primary Indication
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
Concomitant medication - Drug type
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0457591
Beschrijving
Serious Adverse Events - Relevant Medical Conditions/ Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0035648
Beschrijving
MHx Sequence Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Beschrijving
Specific Condition Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschrijving
Medical Condition - Date of onset
Datatype
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Beschrijving
Medical Condition - Continuing?
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beschrijving
Medical Condition - Date of last occurence
Datatype
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2745955
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1517741
Beschrijving
Relevant Medical History / Risk Factors not noted above
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035648
Beschrijving
Serious Adverse Event - Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Beschrijving
Lab Sequence Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Beschrijving
Test Name
Datatype
integer
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Test Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826247
Beschrijving
Test Result
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Test Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beschrijving
Normal Low Range
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Beschrijving
Normal High Range
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205250
Beschrijving
Relevant diagnostic results not noted above
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Serious Adverse Event - Investigational Product
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beschrijving
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0457454
Beschrijving
General Narrative Comments
Alias
- UMLS CUI-1
- C0947611
Beschrijving
Serious Adverse Event - Non clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205210
Beschrijving
Send incomplete SAE data to GSK Safety
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Beschrijving
Receipt by GSK date
Datatype
datetime
Alias
- UMLS CUI [1]
- C2985846
Beschrijving
Was the event serious?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
SAE Sequence Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschrijving
Version Number
Datatype
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Beschrijving
Case ID
Datatype
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beschrijving
Randomisation Number
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschrijving
OCEANS Code
Datatype
text
Alias
- UMLS CUI [1]
- C0805701
Beschrijving
Email Flag
Datatype
text
Alias
- UMLS CUI [1]
- C0013849
Similar models
Logs and Repeats - Adverse Event/ Concomitant Medication/ Repeat Assessment Check Question; Non-Serious Adverse Events; Serious Adverse Events
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0200345 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0332307 (UMLS CUI-2)
C0034656 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C1710056 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
C2347946 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0457591 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0035648 (UMLS CUI [1,2])
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C2348184 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,2])
C0304229 (UMLS CUI-2)
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
C0205210 (UMLS CUI-2)
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])