ID
37505
Beschrijving
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
Trefwoorden
Versies (2)
- 26-07-19 26-07-19 -
- 04-08-19 04-08-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 augustus 2019
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
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
Beschrijving
Were any concomitant medications taken by the subject during the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Did the subject experience any non-serious adverse events during the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Did the subject experience any serious adverse events during the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Were any abnormal 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]
- C0018941
- UMLS CUI [1,2]
- C0200345
Beschrijving
Were any repeat urinalysis samples taken?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0205341
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]
- C1277698
- UMLS CUI [1,2]
- C0031327
- UMLS CUI [1,3]
- C0205341
Beschrijving
Was any Holter monitoring performed?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013801
Beschrijving
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.
Datatype
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
Beschrijving
Non-serious Adverse Event (AE)
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Sequence Number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Modified term
Datatype
text
Alias
- UMLS CUI [1]
- C2826302
Beschrijving
MedDRA synonym
Datatype
text
Alias
- UMLS CUI [1]
- C1140263
Beschrijving
MedDRA lower level term code
Datatype
text
Alias
- UMLS CUI [1]
- C3898442
Beschrijving
Failed coding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
Non-serious Adverse Event Start Date and Time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- 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 and Time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- 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
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
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
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
Beschrijving
Action Taken with Investigational Product(s) as a Result of the AE
Datatype
integer
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
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beschrijving
Time to Onset Since Last Dose
Datatype
durationDatetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Beschrijving
Serious Adverse Events (SAE)
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Initial Report
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0205265
Beschrijving
Follow-Up Report
Datatype
integer
Alias
- UMLS CUI [1]
- C1704685
Beschrijving
Did SAE occur after initiation of study medication?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
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
Modified term
Datatype
text
Alias
- UMLS CUI [1]
- C2826302
Beschrijving
MedDRA synonym
Datatype
text
Alias
- UMLS CUI [1]
- C1140263
Beschrijving
MedDRA lower level term code
Datatype
text
Alias
- UMLS CUI [1]
- C3898442
Beschrijving
Failed coding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
Serious Adverse Events Start Date and Time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1301880
Beschrijving
Serious Adverse Events Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschrijving
Serious Adverse Events End Date and Time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1522314
Beschrijving
Serious Adverse Events Maximum Intensity
Datatype
integer
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
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
Beschrijving
Action Taken with Investigational Product(s) as a Result of the AE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
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]
- C1519255
Beschrijving
Is there a reasonable possibility that the AE 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 AE if < 24 hours
Datatype
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beschrijving
Time to Onset Since Last Dose
Datatype
durationDatetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Beschrijving
Was SAE caused by activities related to study participation (e.g. procedures)?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3641099
- UMLS CUI [1,2]
- C1519255
Beschrijving
Was the event serious?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Check all that apply.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Beschrijving
Serious Adverse Event - Concomitant Medication
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beschrijving
CM Sequence Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Beschrijving
(Trade Name preferred)
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Dose
Datatype
text
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Unit
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Frequency
Datatype
integer
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Route
Datatype
integer
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Concomitant Medication Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Concomitant Medication Ongoing?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
If concomitant medication not ongoing, specify end date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C2826744
Beschrijving
Concomitant medication Primary Indication
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
Drug Type
Datatype
integer
Alias
- UMLS CUI [1]
- C0457591
Beschrijving
Serious Adverse Event - Medical Conditions/ Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Beschrijving
MHx Sequence Number
Datatype
text
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
Date of onset
Datatype
datetime
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
Medical Conditions/ Risk Factors Continuing?
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0549178
Beschrijving
If Medical Conditions/ Risk Factors not Continuing, specify date of last occurence
Datatype
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
Beschrijving
Relevant Medical History/ Risk Factors not noted above
Datatype
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0035648
Beschrijving
Serious Adverse Events - 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]
- C1519795
Beschrijving
Normal Low Range
Datatype
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Beschrijving
Normal High Range
Datatype
text
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 Events - Investigational Products
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0013230
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]
- C0013230
- UMLS CUI [1,2]
- C1272691
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Beschrijving
Serious Adverse Events - General narrative comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beschrijving
Serious Adverse Events - Non clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C1298908
Beschrijving
Send incomplete SAE data to GSK Safety
Datatype
integer
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
text
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
integer
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
Beschrijving
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Sequence number
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
(Trade Name preferred)
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Modified reported term
Datatype
text
Alias
- UMLS CUI [1]
- C2826819
Beschrijving
GSK Drug synonym
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Beschrijving
GSK Drug Collection code
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Beschrijving
Failed coding
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
Unit Dose
Datatype
text
Alias
- UMLS CUI [1]
- C0869039
Beschrijving
Units
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Frequency
Datatype
integer
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Route
Datatype
integer
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Reason for Medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschrijving
Medication Start Date and Time
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826734
- UMLS CUI [2,1]
- C2347852
- UMLS CUI [2,2]
- C1301880
Beschrijving
Medication taken Prior to Study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschrijving
Concomitant medication ongoing?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
End date and time of concomitant medication
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826744
- UMLS CUI [2]
- C1522314
Beschrijving
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0205276
Beschrijving
Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschrijving
If Result of Dipstick is positive, provide details of repeated tests in the add entry section below.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beschrijving
If Yes, provide details of repeated tests in the add entry section below.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2700128
Beschrijving
Urine Dipstick - Laboratory Test
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0022885
Beschrijving
Urine Microscopy - Laboratory Tests
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0022885
Beschrijving
Laboratory Test Result - Numeric Result
Datatype
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2347373
Beschrijving
Laboratory Test Result - Character Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2350015
Beschrijving
Laboratory Test Result - No Result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C1298908
Beschrijving
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
Beschrijving
Vital signs - Semi-supine
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0522019
Beschrijving
Vital Signs Semi-supine - Actual date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C1264639
Beschrijving
Vital Signs Semi-supine - Blood pressure
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005823
Beschrijving
Vital Signs Semi-supine - Systolic blood pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0871470
Beschrijving
Vital Signs Semi-supine - Diastolic blood pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0428883
Beschrijving
Vital Signs Semi-supine - Temperature
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005903
Beschrijving
Vital Signs Semi-supine - Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005903
Beschrijving
Vital Signs Semi-supine - Heart rate
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0018810
Beschrijving
Vital Signs Semi-supine - Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0018810
Beschrijving
Vital Signs Semi-supine - Respiration rate
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0231832
Beschrijving
Vital Signs Semi-supine - Respiration rate
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0231832
Beschrijving
Vital Signs - Standing
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0231472
Beschrijving
Vital Signs Standing - Actual time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0040223
Beschrijving
Vital Signs Standing - Systolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0871470
Beschrijving
Vital Signs Standing - Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0428883
Beschrijving
Vital Signs Standing - Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [2]
- C0231472
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Date and Time of ECG
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
RR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489636
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc (b) Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beschrijving
Lead used for measurement
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Date and Time of ECG
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschrijving
(check all that apply)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0199556
Beschrijving
If other abnormal rhythm, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C0947611
Beschrijving
(check all that apply)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C2216025
Beschrijving
If other P-Wave Morphology, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschrijving
(check all that apply)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0232217
Beschrijving
If other conduction, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschrijving
(check all that apply)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0027051
Beschrijving
If other myocardial infarction, enter comment.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschrijving
(check all that apply)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2,1]
- C1331539
- UMLS CUI [2,2]
- C0948857
Beschrijving
If other depololarisation/repolarisation, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Beschrijving
If other abnormalities, enter comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschrijving
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])