ID
37505
Description
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
Keywords
Versions (2)
- 7/26/19 7/26/19 -
- 8/4/19 8/4/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 4, 2019
DOI
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License
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
Description
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
Description
Were any concomitant medications taken by the subject during the study?
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Did the subject experience any non-serious adverse events during the study?
Data type
boolean
Alias
- UMLS CUI [1]
- C1518404
Description
Did the subject experience any serious adverse events during the study?
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Were any abnormal ECG measurements recorded for this subject during the study?
Data type
boolean
Alias
- UMLS CUI [1]
- C0522055
Description
Were any repeat haematology or clinical chemistry samples taken?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0200345
Description
Were any repeat urinalysis samples taken?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0205341
Description
Were any repeat ECGs performed?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Description
Were any repeat vital signs recorded?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Description
Were any repeat PK blood samples taken?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0031327
- UMLS CUI [1,3]
- C0205341
Description
Was any Holter monitoring performed?
Data type
boolean
Alias
- UMLS CUI [1]
- C0013801
Description
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.
Data type
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
Description
Non-serious Adverse Event (AE)
Alias
- UMLS CUI-1
- C1518404
Description
Sequence Number
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Modified term
Data type
text
Alias
- UMLS CUI [1]
- C2826302
Description
MedDRA synonym
Data type
text
Alias
- UMLS CUI [1]
- C1140263
Description
MedDRA lower level term code
Data type
text
Alias
- UMLS CUI [1]
- C3898442
Description
Failed coding
Data type
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Non-serious Adverse Event Start Date and Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C1301880
Description
Non-serious Adverse Event Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Description
Non-serious Adverse Event End Date and Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C1522314
Description
Non-serious Adverse Event Frequency
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Description
Non-serious Adverse Event Maximum Intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
Description
Non-serious Adverse Event Maximum Grade
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Description
Non-serious Adverse Event Maximum Grade or Intensity
Data type
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
Description
Action Taken with Investigational Product(s) as a Result of the AE
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Description
Did the subject withdraw from study as a result of this AE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Description
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
Duration of AE if < 24 hours
Data type
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Description
Time to Onset Since Last Dose
Data type
durationDatetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Description
Serious Adverse Events (SAE)
Alias
- UMLS CUI-1
- C1519255
Description
Initial Report
Data type
integer
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0205265
Description
Follow-Up Report
Data type
integer
Alias
- UMLS CUI [1]
- C1704685
Description
Did SAE occur after initiation of study medication?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
Description
SAE Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Modified term
Data type
text
Alias
- UMLS CUI [1]
- C2826302
Description
MedDRA synonym
Data type
text
Alias
- UMLS CUI [1]
- C1140263
Description
MedDRA lower level term code
Data type
text
Alias
- UMLS CUI [1]
- C3898442
Description
Failed coding
Data type
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Serious Adverse Events Start Date and Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1301880
Description
Serious Adverse Events Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
Serious Adverse Events End Date and Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1522314
Description
Serious Adverse Events Maximum Intensity
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
Serious Adverse Event Maximum Grade
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Description
Serious Adverse Event Maximum Grade or Intensity
Data type
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
Description
Action Taken with Investigational Product(s) as a Result of the AE
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
Did the subject withdraw from study as a result of this AE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Description
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
Duration of AE if < 24 hours
Data type
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Description
Time to Onset Since Last Dose
Data type
durationDatetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Description
Was SAE caused by activities related to study participation (e.g. procedures)?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3641099
- UMLS CUI [1,2]
- C1519255
Description
Was the event serious?
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Check all that apply.
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Description
Serious Adverse Event - Concomitant Medication
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Description
CM Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Description
(Trade Name preferred)
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Dose
Data type
text
Alias
- UMLS CUI [1]
- C3174092
Description
Unit
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Frequency
Data type
integer
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Data type
integer
Alias
- UMLS CUI [1]
- C0013153
Description
Concomitant Medication Start Date
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant Medication Ongoing?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
If concomitant medication not ongoing, specify end date
Data type
date
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C2826744
Description
Concomitant medication Primary Indication
Data type
text
Alias
- UMLS CUI [1]
- C2826696
Description
Drug Type
Data type
integer
Alias
- UMLS CUI [1]
- C0457591
Description
Serious Adverse Event - Medical Conditions/ Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Description
MHx Sequence Number
Data type
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Description
Specific Condition Name
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Date of onset
Data type
datetime
Alias
- UMLS CUI [1]
- C0574845
Description
Medical Conditions/ Risk Factors Continuing?
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0549178
Description
If Medical Conditions/ Risk Factors not Continuing, specify date of last occurence
Data type
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
Description
Relevant Medical History/ Risk Factors not noted above
Data type
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0035648
Description
Serious Adverse Events - Relevant diagnostic results
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Description
Lab Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Description
Test Name
Data type
integer
Alias
- UMLS CUI [1]
- C0022885
Description
Test Date
Data type
date
Alias
- UMLS CUI [1]
- C2826247
Description
Test Result
Data type
text
Alias
- UMLS CUI [1]
- C0587081
Description
Test Units
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Normal Low Range
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Description
Normal High Range
Data type
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205250
Description
Relevant diagnostic results not noted above
Data type
text
Alias
- UMLS CUI [1]
- C0587081
Description
Serious Adverse Events - Investigational Products
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0013230
Description
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Data type
text
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1272691
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Description
Serious Adverse Events - General narrative comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Description
Serious Adverse Events - Non clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C1298908
Description
Send incomplete SAE data to GSK Safety
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Description
Receipt by GSK date
Data type
datetime
Alias
- UMLS CUI [1]
- C2985846
Description
Was the event serious?
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
SAE Sequence Number
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Version Number
Data type
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Description
Case ID
Data type
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Description
Randomisation Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
OCEANS Code
Data type
text
Alias
- UMLS CUI [1]
- C0805701
Description
Email Flag
Data type
text
Alias
- UMLS CUI [1]
- C0013849
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Sequence number
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
(Trade Name preferred)
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Modified reported term
Data type
text
Alias
- UMLS CUI [1]
- C2826819
Description
GSK Drug synonym
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Description
GSK Drug Collection code
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Description
Failed coding
Data type
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Unit Dose
Data type
text
Alias
- UMLS CUI [1]
- C0869039
Description
Units
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Frequency
Data type
integer
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Data type
integer
Alias
- UMLS CUI [1]
- C0013153
Description
Reason for Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Medication Start Date and Time
Data type
datetime
Alias
- UMLS CUI [1]
- C2826734
- UMLS CUI [2,1]
- C2347852
- UMLS CUI [2,2]
- C1301880
Description
Medication taken Prior to Study?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
Concomitant medication ongoing?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
End date and time of concomitant medication
Data type
datetime
Alias
- UMLS CUI [1]
- C2826744
- UMLS CUI [2]
- C1522314
Description
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0205276
Description
Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Description
If Result of Dipstick is positive, provide details of repeated tests in the add entry section below.
Data type
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Description
If Yes, provide details of repeated tests in the add entry section below.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2700128
Description
Urine Dipstick - Laboratory Test
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0022885
Description
Urine Microscopy - Laboratory Tests
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0022885
Description
Laboratory Test Result - Numeric Result
Data type
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2347373
Description
Laboratory Test Result - Character Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2350015
Description
Laboratory Test Result - No Result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C1298908
Description
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
Description
Vital signs - Semi-supine
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0522019
Description
Vital Signs Semi-supine - Actual date/time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C1264639
Description
Vital Signs Semi-supine - Blood pressure
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005823
Description
Vital Signs Semi-supine - Systolic blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0871470
Description
Vital Signs Semi-supine - Diastolic blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0428883
Description
Vital Signs Semi-supine - Temperature
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005903
Description
Vital Signs Semi-supine - Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005903
Description
Vital Signs Semi-supine - Heart rate
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0018810
Description
Vital Signs Semi-supine - Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0018810
Description
Vital Signs Semi-supine - Respiration rate
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0231832
Description
Vital Signs Semi-supine - Respiration rate
Data type
integer
Measurement units
- breaths/min
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0231832
Description
Vital Signs - Standing
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0231472
Description
Vital Signs Standing - Actual time
Data type
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0040223
Description
Vital Signs Standing - Systolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0871470
Description
Vital Signs Standing - Diastolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0428883
Description
Vital Signs Standing - Heart Rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [2]
- C0231472
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
Date and Time of ECG
Data type
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
RR Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0489636
Description
PR Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C1287082
Description
QTc (b) Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0489625
Description
Method of QTc Calculation
Data type
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Result of the ECG
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Description
Lead used for measurement
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Date and Time of ECG
Data type
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
(check all that apply)
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0199556
Description
If other abnormal rhythm, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C0947611
Description
(check all that apply)
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C2216025
Description
If other P-Wave Morphology, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
(check all that apply)
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0232217
Description
If other conduction, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
(check all that apply)
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0027051
Description
If other myocardial infarction, enter comment.
Data type
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
(check all that apply)
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2,1]
- C1331539
- UMLS CUI [2,2]
- C0948857
Description
If other depololarisation/repolarisation, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Description
If other abnormalities, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
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])