ID
41666
Beschreibung
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
Stichworte
Versionen (1)
- 07.12.20 07.12.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
7. Dezember 2020
DOI
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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
Beschreibung
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
Beschreibung
Were any concomitant medications taken by the subject during the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0347984
Beschreibung
Did the subject experience any non-serious adverse events during the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0347984
Beschreibung
Did the subject experience any serious adverse event during the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2,1]
- C0008976
- UMLS CUI [2,2]
- C0347984
Beschreibung
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0522055
Beschreibung
Were any repeat haematology or clinical chemistry samples taken?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0018941
- UMLS CUI [2,2]
- C0200345
Beschreibung
Were any repeat ECGs performed?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beschreibung
Were any repeat vital signs recorded?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Beschreibung
Were any repeat PK blood samples taken?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0205341
Beschreibung
Were any repeat Pulmonary Function Tests performed?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0205341
Beschreibung
Was any repeat Holter monitoring performed?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0205341
Beschreibung
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beschreibung
Non-Serious Adverse Event Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschreibung
Diagnosis Only (if known) Otherwise Sign/Symptom
Datentyp
text
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
Non-Serious Adverse Event - Modified term
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2826798
Beschreibung
Non-Serious Adverse Event MedDRA synonym
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1140263
Beschreibung
Non-Serious Adverse Event MedDRA lower level term code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C3898442
Beschreibung
Non-Serious Adverse Event - Failed coding
Datentyp
text
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0805701
- UMLS CUI [2,2]
- C0231175
Beschreibung
Non-Serious Adverse Event - Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Beschreibung
Non-Serious Adverse Event - Start Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Beschreibung
Non-Serious Adverse Event Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschreibung
Non-Serious Adverse Event End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beschreibung
Non-Serious Adverse Event - End Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Beschreibung
Non-Serious Adverse Event Frequency
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beschreibung
Non-Serious Adverse Event - Maximum Intensity
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschreibung
Non-Serious Adverse Event - Maximum Grade
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beschreibung
Non-Serious Adverse Event - Maximum Grade or Intensity
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0518690
- UMLS CUI [1,4]
- C0806909
Beschreibung
Action Taken with Investigational Product(s) as a Result of the AE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beschreibung
Did the subject withdraw from study as a result of this AE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beschreibung
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
Duration of AE if < 24 hours
Datentyp
integer
Maßeinheiten
- h
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Beschreibung
Duration of AE if < 24 hours
Datentyp
integer
Maßeinheiten
- min
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Beschreibung
Serious Adverse Event - Type of Report
Alias
- UMLS CUI-1
- C3897642
- UMLS CUI-2
- C0332307
Beschreibung
Serious Adverse Event - Randomisation
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0034656
Beschreibung
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschreibung
SAE Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschreibung
Diagnosis Only (if known) Otherwise Sign/Symptom
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Serious Adverse Event - Modified Term
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826798
Beschreibung
Serious Adverse Event - MedDRA synonym
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Beschreibung
Serious Adverse Event - MedDRA lower level term code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898442
Beschreibung
Serious Adverse Event - Failed coding
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Beschreibung
Serious Adverse Event - Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Beschreibung
Serious Adverse Event - Start Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Beschreibung
Serious Adverse Event - Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschreibung
Serious Adverse Event - End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Beschreibung
Serious Adverse Event - End Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Beschreibung
Serious Adverse Event - Maximum Intensity
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschreibung
Serious Adverse Event - Maximum Grade
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beschreibung
Serious Adverse Event - Maximum Grade or Intensity
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0518690
- UMLS CUI [1,4]
- C0806909
Beschreibung
Action Taken with Investigational Product(s) as a Result of the SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschreibung
Serious Adverse Event - Did the subject withdraw from study as a result of this AE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschreibung
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
Duration of SAE if < 24 hours
Datentyp
integer
Maßeinheiten
- h
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Beschreibung
Duration of SAE if < 24 hours
Datentyp
integer
Maßeinheiten
- min
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Beschreibung
Was SAE caused by activities related to study participation (e.g. procedures)?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Beschreibung
Was the event serious?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Serious Adverse Event - Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Beschreibung
Serious Adverse Event - Relevant Concomitant/ Treatment Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C2347946
- UMLS CUI-4
- C0304229
Beschreibung
CM Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Beschreibung
Concomitant medication - Drug name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2347852
Beschreibung
Concomitant medication dose
Datentyp
float
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C2347852
Beschreibung
Concomitant medication unit
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519795
Beschreibung
Concomitant medication frequency
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Beschreibung
Medication Route
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Beschreibung
Concomitant medication start date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Concomitant Medication continuing?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
If concomitant medication is not ongoing, specify end date.
Datentyp
date
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
Concomitant medication - Primary Indication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
Concomitant medication - Drug type
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0457591
Beschreibung
Serious Adverse Events - Relevant Medical Conditions/ Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0035648
Beschreibung
MHx Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Beschreibung
Specific Condition Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschreibung
Medical Condition - Date of onset
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Beschreibung
Medical Condition - Continuing?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beschreibung
Medical Condition - Date of last occurence
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2745955
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1517741
Beschreibung
Relevant Medical History / Risk Factors not noted above
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035648
Beschreibung
Serious Adverse Event - Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Beschreibung
Lab Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Beschreibung
Test Name
Datentyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Test Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826247
Beschreibung
Test Result
Datentyp
text
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Test Units
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beschreibung
Normal Low Range
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Beschreibung
Normal High Range
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205250
Beschreibung
Relevant diagnostic results not noted above
Datentyp
text
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Serious Adverse Event - Investigational Product
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Beschreibung
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0457454
Beschreibung
General Narrative Comments
Alias
- UMLS CUI-1
- C0947611
Beschreibung
Serious Adverse Event - Non clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205210
Beschreibung
Send incomplete SAE data to GSK Safety
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Beschreibung
Receipt by GSK date
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2985846
Beschreibung
Was the event serious?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
SAE Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschreibung
Version Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Beschreibung
Case ID
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beschreibung
Randomisation Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
OCEANS Code
Datentyp
text
Alias
- UMLS CUI [1]
- C0805701
Beschreibung
Email Flag
Datentyp
text
Alias
- UMLS CUI [1]
- C0013849
Ähnliche Modelle
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])