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
Mots-clés
Versions (2)
- 26/07/2019 26/07/2019 -
- 04/08/2019 04/08/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
4 août 2019
DOI
Pour une demande vous connecter.
Licence
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?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Did the subject experience any non-serious adverse events during the study?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1518404
Description
Did the subject experience any serious adverse events during the study?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Were any abnormal ECG measurements recorded for this subject during the study?
Type de données
boolean
Alias
- UMLS CUI [1]
- C0522055
Description
Were any repeat haematology or clinical chemistry samples taken?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0200345
Description
Were any repeat urinalysis samples taken?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0205341
Description
Were any repeat ECGs performed?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Description
Were any repeat vital signs recorded?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Description
Were any repeat PK blood samples taken?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0031327
- UMLS CUI [1,3]
- C0205341
Description
Was any Holter monitoring performed?
Type de données
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.
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C2348184
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
Description
Modified term
Type de données
text
Alias
- UMLS CUI [1]
- C2826302
Description
MedDRA synonym
Type de données
text
Alias
- UMLS CUI [1]
- C1140263
Description
MedDRA lower level term code
Type de données
text
Alias
- UMLS CUI [1]
- C3898442
Description
Failed coding
Type de données
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Non-serious Adverse Event Start Date and Time
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Description
Non-serious Adverse Event End Date and Time
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Description
Non-serious Adverse Event Maximum Intensity
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
Description
Non-serious Adverse Event Maximum Grade
Type de données
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
Type de données
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
Type de données
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?
Type de données
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?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
Duration of AE if < 24 hours
Type de données
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Description
Time to Onset Since Last Dose
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0205265
Description
Follow-Up Report
Type de données
integer
Alias
- UMLS CUI [1]
- C1704685
Description
Did SAE occur after initiation of study medication?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
Description
SAE Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Type de données
text
Alias
- UMLS CUI [1]
- C1519255
Description
Modified term
Type de données
text
Alias
- UMLS CUI [1]
- C2826302
Description
MedDRA synonym
Type de données
text
Alias
- UMLS CUI [1]
- C1140263
Description
MedDRA lower level term code
Type de données
text
Alias
- UMLS CUI [1]
- C3898442
Description
Failed coding
Type de données
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Serious Adverse Events Start Date and Time
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
Serious Adverse Events End Date and Time
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
Serious Adverse Event Maximum Grade
Type de données
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
Type de données
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
Type de données
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?
Type de données
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?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
Duration of AE if < 24 hours
Type de données
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Description
Time to Onset Since Last Dose
Type de données
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)?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3641099
- UMLS CUI [1,2]
- C1519255
Description
Was the event serious?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Check all that apply.
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Description
(Trade Name preferred)
Type de données
text
Alias
- UMLS CUI [1]
- C0013227
Description
Dose
Type de données
text
Alias
- UMLS CUI [1]
- C3174092
Description
Unit
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Frequency
Type de données
integer
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Type de données
integer
Alias
- UMLS CUI [1]
- C0013153
Description
Concomitant Medication Start Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant Medication Ongoing?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
If concomitant medication not ongoing, specify end date
Type de données
date
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C2826744
Description
Concomitant medication Primary Indication
Type de données
text
Alias
- UMLS CUI [1]
- C2826696
Description
Drug Type
Type de données
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
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Description
Specific Condition Name
Type de données
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Date of onset
Type de données
datetime
Alias
- UMLS CUI [1]
- C0574845
Description
Medical Conditions/ Risk Factors Continuing?
Type de données
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
Type de données
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
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Description
Test Name
Type de données
integer
Alias
- UMLS CUI [1]
- C0022885
Description
Test Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826247
Description
Test Result
Type de données
text
Alias
- UMLS CUI [1]
- C0587081
Description
Test Units
Type de données
text
Alias
- UMLS CUI [1]
- C1519795
Description
Normal Low Range
Type de données
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Description
Normal High Range
Type de données
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205250
Description
Relevant diagnostic results not noted above
Type de données
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?
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Description
Receipt by GSK date
Type de données
datetime
Alias
- UMLS CUI [1]
- C2985846
Description
Was the event serious?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
SAE Sequence Number
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Version Number
Type de données
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Description
Case ID
Type de données
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Description
Randomisation Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
OCEANS Code
Type de données
text
Alias
- UMLS CUI [1]
- C0805701
Description
Email Flag
Type de données
text
Alias
- UMLS CUI [1]
- C0013849
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Sequence number
Type de données
integer
Alias
- UMLS CUI [1]
- C2348184
Description
(Trade Name preferred)
Type de données
text
Alias
- UMLS CUI [1]
- C0013227
Description
Modified reported term
Type de données
text
Alias
- UMLS CUI [1]
- C2826819
Description
GSK Drug synonym
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Description
GSK Drug Collection code
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Description
Failed coding
Type de données
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Unit Dose
Type de données
text
Alias
- UMLS CUI [1]
- C0869039
Description
Units
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Frequency
Type de données
integer
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Type de données
integer
Alias
- UMLS CUI [1]
- C0013153
Description
Reason for Medication
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Description
Medication Start Date and Time
Type de données
datetime
Alias
- UMLS CUI [1]
- C2826734
- UMLS CUI [2,1]
- C2347852
- UMLS CUI [2,2]
- C1301880
Description
Medication taken Prior to Study?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
Concomitant medication ongoing?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
End date and time of concomitant medication
Type de données
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
Type de données
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.
Type de données
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.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2700128
Description
Urine Dipstick - Laboratory Test
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0022885
Description
Urine Microscopy - Laboratory Tests
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0022885
Description
Laboratory Test Result - Numeric Result
Type de données
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2347373
Description
Laboratory Test Result - Character Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2350015
Description
Laboratory Test Result - No Result
Type de données
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
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C1264639
Description
Vital Signs Semi-supine - Blood pressure
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005823
Description
Vital Signs Semi-supine - Systolic blood pressure
Type de données
integer
Unités de mesure
- 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
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0428883
Description
Vital Signs Semi-supine - Temperature
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005903
Description
Vital Signs Semi-supine - Temperature
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005903
Description
Vital Signs Semi-supine - Heart rate
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0018810
Description
Vital Signs Semi-supine - Heart rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0018810
Description
Vital Signs Semi-supine - Respiration rate
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0231832
Description
Vital Signs Semi-supine - Respiration rate
Type de données
integer
Unités de mesure
- 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
Type de données
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0040223
Description
Vital Signs Standing - Systolic Blood Pressure
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0871470
Description
Vital Signs Standing - Diastolic Blood Pressure
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0428883
Description
Vital Signs Standing - Heart Rate
Type de données
integer
Unités de mesure
- 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
Type de données
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
Heart rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
RR Interval
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1]
- C0489636
Description
PR Interval
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT Interval
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1]
- C1287082
Description
QTc (b) Interval
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1]
- C0489625
Description
Method of QTc Calculation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Result of the ECG
Type de données
integer
Alias
- UMLS CUI [1]
- C0438154
Description
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Description
Lead used for measurement
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Date and Time of ECG
Type de données
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
(check all that apply)
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0199556
Description
If other abnormal rhythm, enter comment
Type de données
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)
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C2216025
Description
If other P-Wave Morphology, enter comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
(check all that apply)
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0232217
Description
If other conduction, enter comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
(check all that apply)
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0027051
Description
If other myocardial infarction, enter comment.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
(check all that apply)
Type de données
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
Type de données
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
Type de données
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])