ID
41666
Descripción
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
Palabras clave
Versiones (1)
- 7/12/20 7/12/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
7 de diciembre de 2020
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
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
Descripción
Were any concomitant medications taken by the subject during the study?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0347984
Descripción
Did the subject experience any non-serious adverse events during the study?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0347984
Descripción
Did the subject experience any serious adverse event during the study?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0347984
Descripción
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0522055
Descripción
Were any repeat haematology or clinical chemistry samples taken?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0018941
- UMLS CUI [2,2]
- C0200345
Descripción
Were any repeat ECGs performed?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Descripción
Were any repeat vital signs recorded?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Descripción
Were any repeat PK blood samples taken?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0205341
Descripción
Were any repeat Pulmonary Function Tests performed?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0205341
Descripción
Was any repeat Holter monitoring performed?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0205341
Descripción
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Descripción
Non-Serious Adverse Event Sequence Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Descripción
Diagnosis Only (if known) Otherwise Sign/Symptom
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1518404
Descripción
Non-Serious Adverse Event - Modified term
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2826798
Descripción
Non-Serious Adverse Event MedDRA synonym
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1140263
Descripción
Non-Serious Adverse Event MedDRA lower level term code
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C3898442
Descripción
Non-Serious Adverse Event - Failed coding
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0805701
- UMLS CUI [2,2]
- C0231175
Descripción
Non-Serious Adverse Event - Start Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Descripción
Non-Serious Adverse Event - Start Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Descripción
Non-Serious Adverse Event Outcome
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Descripción
Non-Serious Adverse Event End Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Descripción
Non-Serious Adverse Event - End Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Descripción
Non-Serious Adverse Event Frequency
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Descripción
Non-Serious Adverse Event - Maximum Intensity
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Descripción
Non-Serious Adverse Event - Maximum Grade
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Descripción
Non-Serious Adverse Event - Maximum Grade or Intensity
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0518690
- UMLS CUI [1,4]
- C0806909
Descripción
Action Taken with Investigational Product(s) as a Result of the AE
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Descripción
Did the subject withdraw from study as a result of this AE?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Descripción
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descripción
Duration of AE if < 24 hours
Tipo de datos
integer
Unidades de medida
- h
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Descripción
Duration of AE if < 24 hours
Tipo de datos
integer
Unidades de medida
- min
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Descripción
Serious Adverse Event - Type of Report
Alias
- UMLS CUI-1
- C3897642
- UMLS CUI-2
- C0332307
Descripción
Serious Adverse Event - Randomisation
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0034656
Descripción
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Descripción
SAE Sequence Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Descripción
Diagnosis Only (if known) Otherwise Sign/Symptom
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Descripción
Serious Adverse Event - Modified Term
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826798
Descripción
Serious Adverse Event - MedDRA synonym
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Descripción
Serious Adverse Event - MedDRA lower level term code
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898442
Descripción
Serious Adverse Event - Failed coding
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Descripción
Serious Adverse Event - Start Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Descripción
Serious Adverse Event - Start Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Descripción
Serious Adverse Event - Outcome
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Descripción
Serious Adverse Event - End Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Descripción
Serious Adverse Event - End Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Descripción
Serious Adverse Event - Maximum Intensity
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Descripción
Serious Adverse Event - Maximum Grade
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Descripción
Serious Adverse Event - Maximum Grade or Intensity
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0518690
- UMLS CUI [1,4]
- C0806909
Descripción
Action Taken with Investigational Product(s) as a Result of the SAE
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Descripción
Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Descripción
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descripción
Duration of SAE if < 24 hours
Tipo de datos
integer
Unidades de medida
- h
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Descripción
Duration of SAE if < 24 hours
Tipo de datos
integer
Unidades de medida
- min
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Descripción
Was SAE caused by activities related to study participation (e.g. procedures)?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Descripción
Was the event serious?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
Descripción
Serious Adverse Event - Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Descripción
Serious Adverse Event - Relevant Concomitant/ Treatment Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C2347946
- UMLS CUI-4
- C0304229
Descripción
CM Sequence Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Descripción
Concomitant medication - Drug name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2347852
Descripción
Concomitant medication dose
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C2347852
Descripción
Concomitant medication unit
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519795
Descripción
Concomitant medication frequency
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Descripción
Medication Route
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Descripción
Concomitant medication start date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826734
Descripción
Concomitant Medication continuing?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2826666
Descripción
If concomitant medication is not ongoing, specify end date.
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826744
Descripción
Concomitant medication - Primary Indication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826696
Descripción
Concomitant medication - Drug type
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0457591
Descripción
Serious Adverse Events - Relevant Medical Conditions/ Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0035648
Descripción
MHx Sequence Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Descripción
Specific Condition Name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Descripción
Medical Condition - Date of onset
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Descripción
Medical Condition - Continuing?
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Descripción
Medical Condition - Date of last occurence
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2745955
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1517741
Descripción
Relevant Medical History / Risk Factors not noted above
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035648
Descripción
Serious Adverse Event - Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Descripción
Lab Sequence Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Descripción
Test Name
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0022885
Descripción
Test Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826247
Descripción
Test Result
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0587081
Descripción
Test Units
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Descripción
Normal Low Range
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Descripción
Normal High Range
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205250
Descripción
Relevant diagnostic results not noted above
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0587081
Descripción
Serious Adverse Event - Investigational Product
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Descripción
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0457454
Descripción
General Narrative Comments
Alias
- UMLS CUI-1
- C0947611
Descripción
Serious Adverse Event - Non clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205210
Descripción
Send incomplete SAE data to GSK Safety
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Descripción
Receipt by GSK date
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2985846
Descripción
Was the event serious?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
Descripción
SAE Sequence Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Descripción
Version Number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Descripción
Case ID
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Descripción
Randomisation Number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Descripción
OCEANS Code
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0805701
Descripción
Email Flag
Tipo de datos
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])