ID
37505
Beskrivning
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence
Nyckelord
Versioner (2)
- 2019-07-26 2019-07-26 -
- 2019-08-04 2019-08-04 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
4 augusti 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957
Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events; Concomitant Medication; Electronically Transferred Lab Data; Vital Signs; 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood - GSK618334
Beskrivning
Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions
Alias
- UMLS CUI-1
- C1708728
- UMLS CUI-2
- C0205341
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C1516048
- UMLS CUI-5
- C2347852
- UMLS CUI-6
- C1516048
Beskrivning
Were any concomitant medications taken by the subject during the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Did the subject experience any non-serious adverse events during the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
Did the subject experience any serious adverse events during the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Were any abnormal ECG measurements recorded for this subject during the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0522055
Beskrivning
Were any repeat haematology or clinical chemistry samples taken?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0200345
Beskrivning
Were any repeat urinalysis samples taken?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0205341
Beskrivning
Were any repeat ECGs performed?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beskrivning
Were any repeat vital signs recorded?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Beskrivning
Were any repeat PK blood samples taken?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0031327
- UMLS CUI [1,3]
- C0205341
Beskrivning
Was any Holter monitoring performed?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013801
Beskrivning
If liver event occurred, stop investigational product, complete date stopped on Investigational Product form and contact GSK within 24 hours of occurrence of liver event by phone or fax. If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSl<. *Obtain tests as per protocol *Obtain blood samples for Pharmacokinetics (PK) analysis within 24 hours or 3 ha|f—|ives {insert vaiue of whichever is ionger} of last dose *Complete Liver Event Forms (compieted Liver Event Forms do not need to be supplied to GSK within 24 hours) If Yes to Liver Events, go to the LE DETAILS visit and complete the Liver Event forms.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C2746065
- UMLS CUI [2,3]
- C0243161
Beskrivning
Non-serious Adverse Event (AE)
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Modified term
Datatyp
text
Alias
- UMLS CUI [1]
- C2826302
Beskrivning
MedDRA synonym
Datatyp
text
Alias
- UMLS CUI [1]
- C1140263
Beskrivning
MedDRA lower level term code
Datatyp
text
Alias
- UMLS CUI [1]
- C3898442
Beskrivning
Failed coding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Non-serious Adverse Event Start Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C1301880
Beskrivning
Non-serious Adverse Event Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beskrivning
Non-serious Adverse Event End Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C1522314
Beskrivning
Non-serious Adverse Event Frequency
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beskrivning
Non-serious Adverse Event Maximum Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
Beskrivning
Non-serious Adverse Event Maximum Grade
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beskrivning
Non-serious Adverse Event Maximum Grade or Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0518690
- UMLS CUI [2,3]
- C0806909
Beskrivning
Action Taken with Investigational Product(s) as a Result of the AE
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beskrivning
Did the subject withdraw from study as a result of this AE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beskrivning
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
Duration of AE if < 24 hours
Datatyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beskrivning
Time to Onset Since Last Dose
Datatyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Beskrivning
Serious Adverse Events (SAE)
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Initial Report
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0205265
Beskrivning
Follow-Up Report
Datatyp
integer
Alias
- UMLS CUI [1]
- C1704685
Beskrivning
Did SAE occur after initiation of study medication?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
Beskrivning
SAE Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Modified term
Datatyp
text
Alias
- UMLS CUI [1]
- C2826302
Beskrivning
MedDRA synonym
Datatyp
text
Alias
- UMLS CUI [1]
- C1140263
Beskrivning
MedDRA lower level term code
Datatyp
text
Alias
- UMLS CUI [1]
- C3898442
Beskrivning
Failed coding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Serious Adverse Events Start Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1301880
Beskrivning
Serious Adverse Events Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beskrivning
Serious Adverse Events End Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1522314
Beskrivning
Serious Adverse Events Maximum Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
Serious Adverse Event Maximum Grade
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beskrivning
Serious Adverse Event Maximum Grade or Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0518690
- UMLS CUI [2,3]
- C0806909
Beskrivning
Action Taken with Investigational Product(s) as a Result of the AE
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beskrivning
Did the subject withdraw from study as a result of this AE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beskrivning
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
Duration of AE if < 24 hours
Datatyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beskrivning
Time to Onset Since Last Dose
Datatyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Beskrivning
Was SAE caused by activities related to study participation (e.g. procedures)?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3641099
- UMLS CUI [1,2]
- C1519255
Beskrivning
Was the event serious?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Check all that apply.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Beskrivning
Serious Adverse Event - Concomitant Medication
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beskrivning
CM Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Beskrivning
(Trade Name preferred)
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Dose
Datatyp
text
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
Unit
Datatyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Frequency
Datatyp
integer
Alias
- UMLS CUI [1]
- C3476109
Beskrivning
Route
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Concomitant Medication Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
Concomitant Medication Ongoing?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
If concomitant medication not ongoing, specify end date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C2826744
Beskrivning
Concomitant medication Primary Indication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826696
Beskrivning
Drug Type
Datatyp
integer
Alias
- UMLS CUI [1]
- C0457591
Beskrivning
Serious Adverse Event - Medical Conditions/ Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Beskrivning
MHx Sequence Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Beskrivning
Specific Condition Name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beskrivning
Date of onset
Datatyp
datetime
Alias
- UMLS CUI [1]
- C0574845
Beskrivning
Medical Conditions/ Risk Factors Continuing?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0549178
Beskrivning
If Medical Conditions/ Risk Factors not Continuing, specify date of last occurence
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0011008
- UMLS CUI [2,3]
- C2745955
Beskrivning
Relevant Medical History/ Risk Factors not noted above
Datatyp
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0035648
Beskrivning
Serious Adverse Events - Relevant diagnostic results
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Beskrivning
Lab Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Beskrivning
Test Name
Datatyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Test Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826247
Beskrivning
Test Result
Datatyp
text
Alias
- UMLS CUI [1]
- C0587081
Beskrivning
Test Units
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Normal Low Range
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Beskrivning
Normal High Range
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205250
Beskrivning
Relevant diagnostic results not noted above
Datatyp
text
Alias
- UMLS CUI [1]
- C0587081
Beskrivning
Serious Adverse Events - Investigational Products
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0013230
Beskrivning
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1272691
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Beskrivning
Serious Adverse Events - General narrative comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beskrivning
Serious Adverse Events - Non clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C1298908
Beskrivning
Send incomplete SAE data to GSK Safety
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Beskrivning
Receipt by GSK date
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2985846
Beskrivning
Was the event serious?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
SAE Sequence Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
Version Number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Beskrivning
Case ID
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beskrivning
Randomisation Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beskrivning
OCEANS Code
Datatyp
text
Alias
- UMLS CUI [1]
- C0805701
Beskrivning
Email Flag
Datatyp
text
Alias
- UMLS CUI [1]
- C0013849
Beskrivning
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Sequence number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
(Trade Name preferred)
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Modified reported term
Datatyp
text
Alias
- UMLS CUI [1]
- C2826819
Beskrivning
GSK Drug synonym
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Beskrivning
GSK Drug Collection code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Beskrivning
Failed coding
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Unit Dose
Datatyp
text
Alias
- UMLS CUI [1]
- C0869039
Beskrivning
Units
Datatyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Frequency
Datatyp
integer
Alias
- UMLS CUI [1]
- C3476109
Beskrivning
Route
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Reason for Medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beskrivning
Medication Start Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826734
- UMLS CUI [2,1]
- C2347852
- UMLS CUI [2,2]
- C1301880
Beskrivning
Medication taken Prior to Study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826667
Beskrivning
Concomitant medication ongoing?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
End date and time of concomitant medication
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826744
- UMLS CUI [2]
- C1522314
Beskrivning
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0205276
Beskrivning
Date and time sample taken
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beskrivning
If Result of Dipstick is positive, provide details of repeated tests in the add entry section below.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beskrivning
If Yes, provide details of repeated tests in the add entry section below.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2700128
Beskrivning
Urine Dipstick - Laboratory Test
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0022885
Beskrivning
Urine Microscopy - Laboratory Tests
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0022885
Beskrivning
Laboratory Test Result - Numeric Result
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2347373
Beskrivning
Laboratory Test Result - Character Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2350015
Beskrivning
Laboratory Test Result - No Result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C1298908
Beskrivning
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
Beskrivning
Vital signs - Semi-supine
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0522019
Beskrivning
Vital Signs Semi-supine - Actual date/time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C1264639
Beskrivning
Vital Signs Semi-supine - Blood pressure
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005823
Beskrivning
Vital Signs Semi-supine - Systolic blood pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0871470
Beskrivning
Vital Signs Semi-supine - Diastolic blood pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0428883
Beskrivning
Vital Signs Semi-supine - Temperature
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005903
Beskrivning
Vital Signs Semi-supine - Temperature
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005903
Beskrivning
Vital Signs Semi-supine - Heart rate
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0018810
Beskrivning
Vital Signs Semi-supine - Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0018810
Beskrivning
Vital Signs Semi-supine - Respiration rate
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0231832
Beskrivning
Vital Signs Semi-supine - Respiration rate
Datatyp
integer
Måttenheter
- breaths/min
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0231832
Beskrivning
Vital Signs - Standing
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0231472
Beskrivning
Vital Signs Standing - Actual time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0040223
Beskrivning
Vital Signs Standing - Systolic Blood Pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0871470
Beskrivning
Vital Signs Standing - Diastolic Blood Pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0428883
Beskrivning
Vital Signs Standing - Heart Rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [2]
- C0231472
Beskrivning
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beskrivning
Date and Time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
RR Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0489636
Beskrivning
PR Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS Duration
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
Uncorrected QT Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
QTc (b) Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0489625
Beskrivning
Method of QTc Calculation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beskrivning
Result of the ECG
Datatyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beskrivning
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beskrivning
Lead used for measurement
Datatyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Date and Time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beskrivning
(check all that apply)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0199556
Beskrivning
If other abnormal rhythm, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C0947611
Beskrivning
(check all that apply)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C2216025
Beskrivning
If other P-Wave Morphology, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
(check all that apply)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0232217
Beskrivning
If other conduction, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
(check all that apply)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0027051
Beskrivning
If other myocardial infarction, enter comment.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
(check all that apply)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2,1]
- C1331539
- UMLS CUI [2,2]
- C0948857
Beskrivning
If other depololarisation/repolarisation, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Beskrivning
If other abnormalities, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
Repeat Pharmacokinetics Blood - GSK618334
Similar models
Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events; Concomitant Medication; Electronically Transferred Lab Data; Vital Signs; 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood - GSK618334
C2985720 (UMLS CUI [1,2])
C0205341 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C1516048 (UMLS CUI-4)
C2347852 (UMLS CUI-5)
C1516048 (UMLS CUI-6)
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C2746065 (UMLS CUI [2,2])
C0243161 (UMLS CUI [2,3])
C0231175 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0439603 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
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])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C2348184 (UMLS CUI [1,2])
C2826744 (UMLS CUI [1,2])
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
C0035648 (UMLS CUI [2])
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C2348184 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,2])
C0013230 (UMLS CUI-2)
C1272691 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0947611 (UMLS CUI-2)
C0205210 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
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])
C0871468 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1522314 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C2700128 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0522019 (UMLS CUI-2)
C0522019 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0005903 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0005903 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0018810 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0018810 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0231832 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0231832 (UMLS CUI [2])
C0231472 (UMLS CUI-2)
C0231472 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2])
C0231472 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0231472 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2])
C0018810 (UMLS CUI [1,2])
C0231472 (UMLS CUI [2])
C2911685 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0199556 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C2826293 (UMLS CUI [1,2])
C2216025 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C1331539 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])