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

  1. 7/26/19 7/26/19 -
  2. 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

Logs and Repeats
Description

Logs and Repeats

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0205341
Date of visit/assessment
Description

Date of visit/assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions
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
Were any concomitant medications taken by the subject during the study?
Description

Were any concomitant medications taken by the subject during the study?

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Description

Did the subject experience any non-serious adverse events during the study?

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Description

Did the subject experience any serious adverse events during the study?

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Were any abnormal ECG measurements recorded for this subject during the study?
Description

Were any abnormal ECG measurements recorded for this subject during the study?

Data type

boolean

Alias
UMLS CUI [1]
C0522055
Were any repeat haematology or clinical chemistry samples taken?
Description

Were any repeat haematology or clinical chemistry samples taken?

Data type

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0200345
Were any repeat urinalysis samples taken?
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
Were any repeat ECGs performed?
Description

Were any repeat ECGs performed?

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
Were any repeat vital signs recorded?
Description

Were any repeat vital signs recorded?

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat PK blood samples taken?
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
Was any Holter monitoring performed?
Description

Was any Holter monitoring performed?

Data type

boolean

Alias
UMLS CUI [1]
C0013801
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
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
Non-serious Adverse Event (AE)
Description

Non-serious Adverse Event (AE)

Alias
UMLS CUI-1
C1518404
Sequence Number
Description

Sequence Number

Data type

integer

Alias
UMLS CUI [1]
C2348184
Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C0877248
Modified term
Description

Modified term

Data type

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Description

MedDRA synonym

Data type

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Description

MedDRA lower level term code

Data type

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Description

Failed coding

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Non-serious Adverse Event Start Date and Time
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
Non-serious Adverse Event Outcome
Description

Non-serious Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Non-serious Adverse Event End Date and Time
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
Non-serious Adverse Event Frequency
Description

Non-serious Adverse Event Frequency

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Non-serious Adverse Event Maximum Intensity
Description

Non-serious Adverse Event Maximum Intensity

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
Non-serious Adverse Event Maximum Grade
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
Non-serious Adverse Event Maximum Grade or Intensity
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
Action Taken with Investigational Product(s) as a Result of the AE
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
Did the subject withdraw from study as a result of this AE?
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
Is there a reasonable possibility that the AE may have been caused by the investigational product?
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
Duration of AE if < 24 hours
Description

Duration of AE if < 24 hours

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
Time to Onset Since Last Dose
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
Serious Adverse Events (SAE)
Description

Serious Adverse Events (SAE)

Alias
UMLS CUI-1
C1519255
Initial Report
Description

Initial Report

Data type

integer

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0205265
Follow-Up Report
Description

Follow-Up Report

Data type

integer

Alias
UMLS CUI [1]
C1704685
Did SAE occur after initiation of study medication?
Description

Did SAE occur after initiation of study medication?

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
SAE Sequence Number
Description

SAE Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C1519255
Modified term
Description

Modified term

Data type

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Description

MedDRA synonym

Data type

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Description

MedDRA lower level term code

Data type

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Description

Failed coding

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Serious Adverse Events Start Date and Time
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
Serious Adverse Events Outcome
Description

Serious Adverse Events Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Serious Adverse Events End Date and Time
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
Serious Adverse Events Maximum Intensity
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
Serious Adverse Event Maximum Grade
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
Serious Adverse Event Maximum Grade or Intensity
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
Action Taken with Investigational Product(s) as a Result of the AE
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
Did the subject withdraw from study as a result of this AE?
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
Is there a reasonable possibility that the AE may have been caused by the investigational product?
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
Duration of AE if < 24 hours
Description

Duration of AE if < 24 hours

Data type

durationDatetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
Time to Onset Since Last Dose
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
Was SAE caused by activities related to study participation (e.g. procedures)?
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
Was the event serious?
Description

Was the event serious?

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Specify the reason for considering this an SAE.
Description

Check all that apply.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0392360
Serious Adverse Event - Concomitant Medication
Description

Serious Adverse Event - Concomitant Medication

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
CM Sequence Number
Description

CM Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2348184
Drug Name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Dose
Description

Dose

Data type

text

Alias
UMLS CUI [1]
C3174092
Unit
Description

Unit

Data type

integer

Alias
UMLS CUI [1]
C1519795
Frequency
Description

Frequency

Data type

integer

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

integer

Alias
UMLS CUI [1]
C0013153
Concomitant Medication Start Date
Description

Concomitant Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Concomitant Medication Ongoing?
Description

Concomitant Medication Ongoing?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
If concomitant medication not ongoing, specify end date
Description

If concomitant medication not ongoing, specify end date

Data type

date

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C2826744
Concomitant medication Primary Indication
Description

Concomitant medication Primary Indication

Data type

text

Alias
UMLS CUI [1]
C2826696
Drug Type
Description

Drug Type

Data type

integer

Alias
UMLS CUI [1]
C0457591
Serious Adverse Event - Medical Conditions/ Risk Factors
Description

Serious Adverse Event - Medical Conditions/ Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0012634
UMLS CUI-3
C0035648
MHx Sequence Number
Description

MHx Sequence Number

Data type

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C0262926
Specific Condition Name
Description

Specific Condition Name

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Date of onset
Description

Date of onset

Data type

datetime

Alias
UMLS CUI [1]
C0574845
Medical Conditions/ Risk Factors Continuing?
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
If Medical Conditions/ Risk Factors not Continuing, specify date of last occurence
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
Relevant Medical History/ Risk Factors not noted above
Description

Relevant Medical History/ Risk Factors not noted above

Data type

text

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0035648
Serious Adverse Events - Relevant diagnostic results
Description

Serious Adverse Events - Relevant diagnostic results

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0430022
UMLS CUI-3
C0456984
Lab Sequence Number
Description

Lab Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C2348184
Test Name
Description

Test Name

Data type

integer

Alias
UMLS CUI [1]
C0022885
Test Date
Description

Test Date

Data type

date

Alias
UMLS CUI [1]
C2826247
Test Result
Description

Test Result

Data type

text

Alias
UMLS CUI [1]
C0587081
Test Units
Description

Test Units

Data type

text

Alias
UMLS CUI [1]
C1519795
Normal Low Range
Description

Normal Low Range

Data type

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205251
Normal High Range
Description

Normal High Range

Data type

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205250
Relevant diagnostic results not noted above
Description

Relevant diagnostic results not noted above

Data type

text

Alias
UMLS CUI [1]
C0587081
Serious Adverse Events - Investigational Products
Description

Serious Adverse Events - Investigational Products

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0013230
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
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
Serious Adverse Events - General narrative comments
Description

Serious Adverse Events - General narrative comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
General narrative comments
Description

General narrative comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Serious Adverse Events - Non clinical
Description

Serious Adverse Events - Non clinical

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0205210
UMLS CUI-3
C1298908
Send incomplete SAE data to GSK Safety
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
Receipt by GSK date
Description

Receipt by GSK date

Data type

datetime

Alias
UMLS CUI [1]
C2985846
Was the event serious?
Description

Was the event serious?

Data type

boolean

Alias
UMLS CUI [1]
C1519255
SAE Sequence Number
Description

SAE Sequence Number

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Version Number
Description

Version Number

Data type

text

Alias
UMLS CUI [1,1]
C0333052
UMLS CUI [1,2]
C0237753
Case ID
Description

Case ID

Data type

text

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Randomisation Number
Description

Randomisation Number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
OCEANS Code
Description

OCEANS Code

Data type

text

Alias
UMLS CUI [1]
C0805701
Email Flag
Description

Email Flag

Data type

text

Alias
UMLS CUI [1]
C0013849
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Sequence number
Description

Sequence number

Data type

integer

Alias
UMLS CUI [1]
C2348184
Drug Name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Description

Modified reported term

Data type

text

Alias
UMLS CUI [1]
C2826819
GSK Drug synonym
Description

GSK Drug synonym

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
GSK Drug Collection code
Description

GSK Drug Collection code

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Description

Failed coding

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Unit Dose
Description

Unit Dose

Data type

text

Alias
UMLS CUI [1]
C0869039
Units
Description

Units

Data type

integer

Alias
UMLS CUI [1]
C1519795
Frequency
Description

Frequency

Data type

integer

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

integer

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

Reason for Medication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Medication Start Date and Time
Description

Medication Start Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C2826734
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C1301880
Medication taken Prior to Study?
Description

Medication taken Prior to Study?

Data type

boolean

Alias
UMLS CUI [1]
C2826667
Concomitant medication ongoing?
Description

Concomitant medication ongoing?

Data type

boolean

Alias
UMLS CUI [1]
C2826666
End date and time of concomitant medication
Description

End date and time of concomitant medication

Data type

datetime

Alias
UMLS CUI [1]
C2826744
UMLS CUI [2]
C1522314
Urinalysis - Local
Description

Urinalysis - Local

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0205276
Date and time sample taken
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
Result of Dipstick
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
Was sedimentary microscopy performed?
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
Urine Dipstick - Laboratory Test
Description

Urine Dipstick - Laboratory Test

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0022885
Urine Microscopy - Laboratory Tests
Description

Urine Microscopy - Laboratory Tests

Data type

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0022885
Laboratory Test Result - Numeric Result
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
Laboratory Test Result - Character Result
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
Laboratory Test Result - No Result
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
Electronically Transferred Lab Data
Description

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Laboratory Test Type
Description

Laboratory Test Type

Data type

text

Alias
UMLS CUI [1]
C0022885
Date and time sample taken
Description

Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0200345
UMLS CUI [2,2]
C0040223
Vital signs - Semi-supine
Description

Vital signs - Semi-supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
Vital Signs Semi-supine - Actual date/time
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
Vital Signs Semi-supine - Blood pressure
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
Vital Signs Semi-supine - Systolic blood pressure
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
mm[Hg]
Vital Signs Semi-supine - Diastolic blood pressure
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
mm[Hg]
Vital Signs Semi-supine - Temperature
Description

Vital Signs Semi-supine - Temperature

Data type

integer

Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0522019
UMLS CUI [2]
C0005903
Vital Signs Semi-supine - Temperature
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
°C
Vital Signs Semi-supine - Heart rate
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
Vital Signs Semi-supine - Heart rate
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
beats/min
Vital Signs Semi-supine - Respiration rate
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
Vital Signs Semi-supine - Respiration rate
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
breaths/min
Vital Signs - Standing
Description

Vital Signs - Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0231472
Vital Signs Standing - Actual time
Description

Vital Signs Standing - Actual time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0231472
UMLS CUI [2]
C0040223
Vital Signs Standing - Systolic Blood Pressure
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
mm[Hg]
Vital Signs Standing - Diastolic Blood Pressure
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
mm[Hg]
Vital Signs Standing - Heart Rate
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
beats/min
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Description

RR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489636
ms
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Description

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc (b) Interval
Description

QTc (b) Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
ECG Abnormalities
Description

ECG Abnormalities

Alias
UMLS CUI-1
C0522055
Lead used for measurement
Description

Lead used for measurement

Data type

integer

Alias
UMLS CUI [1]
C1519795
Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
Record clinically significant abnormalities - A. Rhythm
Description

(check all that apply)

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0199556
If other abnormal rhythm, enter comment
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
Record clinically significant abnormalities - B. P-Wave Morphology
Description

(check all that apply)

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C2216025
If other P-Wave Morphology, enter comment
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
Record clinically significant abnormalities - C. Conduction
Description

(check all that apply)

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0232217
If other conduction, enter comment
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
Record clinically significant abnormalities - D. Myocardial infarction
Description

(check all that apply)

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0027051
If other myocardial infarction, enter comment.
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
Record clinically significant abnormalities - E. Depolarisation/Repolarisation (QRS-T) +
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
If other depololarisation/repolarisation, enter comment
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
If other abnormalities, enter comment
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
Repeat Pharmacokinetics Blood - GSK618334
Description

Repeat Pharmacokinetics Blood - GSK618334

Actual date/time
Description

Actual date/time

Data type

datetime

Alias
UMLS CUI [1]
C1264639

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Logs and Repeats
C1708728 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions
C1708728 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C1516048 (UMLS CUI-4)
C2347852 (UMLS CUI-5)
C1516048 (UMLS CUI-6)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Did the subject experience any serious adverse events during the study?
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Were any abnormal ECG measurements recorded for this subject during the study?
Item
Were any abnormal ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1])
Were any repeat haematology or clinical chemistry samples taken?
Item
Were any repeat haematology or clinical chemistry samples taken?
boolean
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Were any repeat urinalysis samples taken?
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Were any repeat ECGs performed?
Item
Were any repeat ECGs performed?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat vital signs recorded?
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat PK blood samples taken?
Item
Were any repeat PK blood samples taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Was any Holter monitoring performed?
Item
Was any Holter monitoring performed?
boolean
C0013801 (UMLS CUI [1])
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
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])
Item Group
Non-serious Adverse Event (AE)
C1518404 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Non-serious Adverse Event Start Date and Time
Item
Non-serious Adverse Event Start Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Item
Non-serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Code List
Non-serious Adverse Event Outcome
CL Item
Recovered/Resolved, provide End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (4)
Non-serious Adverse Event End Date and Time
Item
Non-serious Adverse Event End Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item
Non-serious Adverse Event Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Code List
Non-serious Adverse Event Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Non-serious Adverse Event Maximum Intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Non-serious Adverse Event Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Non-serious Adverse Event Maximum Grade
integer
C1518404 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Non-serious Adverse Event Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Non-serious Adverse Event Maximum Grade or Intensity
integer
C1518404 (UMLS CUI [1,1])
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])
Code List
Non-serious Adverse Event Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
durationDatetime
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
durationDatetime
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Item Group
Serious Adverse Events (SAE)
C1519255 (UMLS CUI-1)
Item
Initial Report
integer
C0684224 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Code List
Initial Report
CL Item
Initial (1)
Item
Follow-Up Report
integer
C1704685 (UMLS CUI [1])
Code List
Follow-Up Report
CL Item
Follow- Up (1)
Did SAE occur after initiation of study medication?
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Modified term
Item
Modified term
text
C2826302 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Serious Adverse Events Start Date and Time
Item
Serious Adverse Events Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Item
Serious Adverse Events Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Code List
Serious Adverse Events Outcome
CL Item
Recovered/Resolved, provide End Date (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
CL Item
Fatal, record Date and Time of Death (5)
Serious Adverse Events End Date and Time
Item
Serious Adverse Events End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item
Serious Adverse Events Maximum Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Serious Adverse Events Maximum Intensity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe  (3)
CL Item
Not applicable (4)
Item
Serious Adverse Event Maximum Grade
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Serious Adverse Event Maximum Grade
CL Item
Grade 1  (1)
CL Item
Grade 2  (2)
CL Item
Grade 3  (3)
CL Item
Grade 4  (4)
CL Item
Grade 5  (5)
CL Item
Not applicable (6)
Item
Serious Adverse Event Maximum Grade or Intensity
integer
C1519255 (UMLS CUI [1,1])
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])
Code List
Serious Adverse Event Maximum Grade or Intensity
CL Item
Mild or Grade 1  (1)
CL Item
Moderate or Grade 2  (2)
CL Item
Severe or Grade 3  (3)
CL Item
Grade 4  (4)
CL Item
Grade 5  (5)
CL Item
Not applicable (6)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn  (1)
CL Item
Dose reduced  (2)
CL Item
Dose increased  (3)
CL Item
Dose not changed  (4)
CL Item
Dose interrupted  (5)
CL Item
Not applicable (6)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
durationDatetime
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
durationDatetime
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Was SAE caused by activities related to study participation (e.g. procedures)?
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
boolean
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item
Specify the reason for considering this an SAE.
text
C1519255 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Specify the reason for considering this an SAE.
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify within general narrative comment (F)
Item Group
Serious Adverse Event - Concomitant Medication
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
CM Sequence Number
Item
CM Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Item
Unit
integer
C1519795 (UMLS CUI [1])
Code List
Unit
CL Item
Actuation (1)
CL Item
Ampoule (2)
CL Item
Application (3)
CL Item
Bottle (4)
CL Item
Capsule (5)
CL Item
Cubic centimeter (6)
CL Item
Drops (7)
CL Item
Gram (8)
CL Item
International units (9)
CL Item
International units per kilogram (10)
CL Item
International units per millilitre (11)
CL Item
Litre (12)
CL Item
Litre per minute (13)
CL Item
Lozenge  (14)
CL Item
Megaunits (million units)  (15)
CL Item
Microgram (MCG)  (16)
CL Item
Microgram (UG)  (17)
CL Item
Microgram/kilogram  (18)
CL Item
Microgram/kilogram per minute  (19)
CL Item
Micrograms per minute  (20)
CL Item
Microlitre (21)
CL Item
Milliequivalent (22)
CL Item
Milliequivalent per 24 hours (23)
CL Item
Milligram (24)
CL Item
Milligrams percent  (25)
CL Item
Milligram per hour  (26)
CL Item
Milligram/kilogram  (27)
CL Item
Milligram/kilogram per hour  (28)
CL Item
Milligram/kilogram per minute  (29)
CL Item
Milligram/metre squared (30)
CL Item
Milligram/millilitre  (31)
CL Item
Millilitre  (32)
CL Item
Millilitre per hour  (33)
CL Item
Millilitre per minute  (34)
CL Item
Millimole (35)
CL Item
Million international units  (36)
CL Item
Minimum alveolar concentration  (37)
CL Item
Nebule  (38)
CL Item
Patch  (39)
CL Item
Percent  (40)
CL Item
Puff  (41)
CL Item
Sachet  (42)
CL Item
Spray  (43)
CL Item
Suppository (44)
CL Item
Tablespoon  (45)
CL Item
Tablet  (46)
CL Item
Teaspoon  (47)
CL Item
Units  (48)
CL Item
Unknown  (49)
CL Item
Vial (50)
Item
Frequency
integer
C3476109 (UMLS CUI [1])
Code List
Frequency
CL Item
2 times per week (1)
CL Item
3 times per week  (2)
CL Item
4 times per week  (3)
CL Item
5 times per day  (4)
CL Item
5 times per week  (5)
CL Item
AC (6)
CL Item
BID  (7)
CL Item
Continuous infusion  (8)
CL Item
Every 2 weeks  (9)
CL Item
Every 3 weeks  (10)
CL Item
Every 3 months  (11)
CL Item
Every other day  (12)
CL Item
At Bedtime (13)
CL Item
Once a month  (14)
CL Item
Once a week  (15)
CL Item
Once daily  (16)
CL Item
Once only  (17)
CL Item
PC  (18)
CL Item
PRN  (19)
CL Item
Q2H  (20)
CL Item
Q3D  (21)
CL Item
Q4D  (22)
CL Item
Q4H (23)
CL Item
Q6H (24)
CL Item
Q8H  (25)
CL Item
Q12H (26)
CL Item
QAM (27)
CL Item
QH  (28)
CL Item
QID (29)
CL Item
QPM  (30)
CL Item
TID  (31)
CL Item
Unknown (32)
Item
Route
integer
C0013153 (UMLS CUI [1])
Code List
Route
CL Item
Both eyes (1)
CL Item
Epidural  (2)
CL Item
Gastrostomy tube  (3)
CL Item
Inhalation  (4)
CL Item
Injection (5)
CL Item
Intra-arterial  (6)
CL Item
Intra-bursa (7)
CL Item
Intralesional  (8)
CL Item
Intramuscular  (9)
CL Item
Intranasal  (10)
CL Item
Intraocular  (11)
CL Item
Intraosteal  (12)
CL Item
Intraperitoneal  (13)
CL Item
Intrathecal  (14)
CL Item
Intrauterine  (15)
CL Item
Intravenous (16)
CL Item
Nasal  (17)
CL Item
Oral  (18)
CL Item
Rectal (19)
CL Item
Subcutaneous  (20)
CL Item
Sublingual (21)
CL Item
Topical (22)
CL Item
Transdermal (23)
CL Item
Unknown (24)
CL Item
Vaginal (25)
Concomitant Medication Start Date
Item
Concomitant Medication Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Medication Ongoing?
Item
Concomitant Medication Ongoing?
boolean
C2826666 (UMLS CUI [1])
If concomitant medication not ongoing, specify end date
Item
If concomitant medication not ongoing, specify end date
date
C2826666 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])
Concomitant medication Primary Indication
Item
Concomitant medication Primary Indication
text
C2826696 (UMLS CUI [1])
Item
Drug Type
integer
C0457591 (UMLS CUI [1])
Code List
Drug Type
CL Item
Concomitant  (1)
CL Item
Treatment (2)
CL Item
Cause of SAE (3)
Item Group
Serious Adverse Event - Medical Conditions/ Risk Factors
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
MHx Sequence Number
Item
MHx Sequence Number
text
C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Specific Condition Name
Item
Specific Condition Name
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
datetime
C0574845 (UMLS CUI [1])
Item
Medical Conditions/ Risk Factors Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Code List
Medical Conditions/ Risk Factors Continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
If Medical Conditions/ Risk Factors not Continuing, specify date of last occurence
Item
If Medical Conditions/ Risk Factors not Continuing, specify date of last occurence
date
C0012634 (UMLS CUI [1,1])
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])
Relevant Medical History/ Risk Factors not noted above
Item
Relevant Medical History/ Risk Factors not noted above
text
C0012634 (UMLS CUI [1])
C0035648 (UMLS CUI [2])
Item Group
Serious Adverse Events - Relevant diagnostic results
C1519255 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Lab Sequence Number
Item
Lab Sequence Number
integer
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Test Name
integer
C0022885 (UMLS CUI [1])
Code List
Test Name
CL Item
Activated partial thromboplastin time (1)
CL Item
Albumin  (2)
CL Item
Alkaline phosphatase (3)
CL Item
Amylase  (4)
CL Item
Basophils (5)
CL Item
Bicarbonate (6)
CL Item
Bilirubin (7)
CL Item
Bilirubin direct  (8)
CL Item
Bilirubin total  (9)
CL Item
Blood myoglobin (10)
CL Item
Blood pH  (11)
CL Item
Blood pressure (12)
CL Item
Blood urea nitrogen  (13)
CL Item
Body temperature  (14)
CL Item
Calcium  (15)
CL Item
CD4 lymphocytes  (16)
CL Item
CD8 lymphocytes  (17)
CL Item
Chloride (18)
CL Item
Cholesterol total  (19)
CL Item
C-reactive protein (20)
CL Item
Creatine (21)
CL Item
Creatine phosphokinase (22)
CL Item
Creatine phosphokinase MB  (23)
CL Item
Creatinine (24)
CL Item
Creatinine clearance  (25)
CL Item
Diastolic blood pressure  (26)
CL Item
Eosinophils  (27)
CL Item
Erythrocyte sedimentation rate  (28)
CL Item
Fasting blood glucose  (29)
CL Item
FEV 1 (30)
CL Item
Gamma-glutamyltransferase  (31)
CL Item
Glutamic-oxaloacetic transferase  (32)
CL Item
Glutamic-pyruvate transaminase  (33)
CL Item
HbA1c  (34)
CL Item
HBV-DNA decreased  (35)
CL Item
HBV-DNA increased  (36)
CL Item
Heart rate  (37)
CL Item
Hematocrit  (38)
CL Item
Hemoglobin (39)
CL Item
High density lipoprotein (40)
CL Item
HIV viral load  (41)
CL Item
INR (42)
CL Item
Lactic dehydrogenase (43)
CL Item
Lipase  (44)
CL Item
Low density lipoprotein  (45)
CL Item
Lymphocytes  (46)
CL Item
Magnesium  (47)
CL Item
Mean cell hemoglobin concentration  (48)
CL Item
Mean corpuscular hemoglobin  (49)
CL Item
Mean corpuscular volume  (50)
CL Item
Monocytes  (51)
CL Item
Neutrophils  (52)
CL Item
Oxygen saturation  (53)
CL Item
pCO2 (54)
CL Item
pH  (55)
CL Item
Phosphate  (56)
CL Item
Platelet count  (57)
CL Item
pO2  (58)
CL Item
Potassium  (59)
CL Item
Protein total  (60)
CL Item
Prothrombin time (61)
CL Item
Red blood cell count  (62)
CL Item
Respiratory rate  (63)
CL Item
Reticulocyte count  (64)
CL Item
Serum glucose  (65)
CL Item
Serum uric acid  (66)
CL Item
Sodium  (67)
CL Item
Systolic blood pressure  (68)
CL Item
Thrombin time  (69)
CL Item
Total lung capacity  (70)
CL Item
Triglycerides  (71)
CL Item
Troponin  (72)
CL Item
Troponin I  (73)
CL Item
Troponin T  (74)
CL Item
Urine myoglobin  (75)
CL Item
Urine pH  (76)
CL Item
Vital capacity  (77)
CL Item
White blood cell count (78)
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Result
Item
Test Result
text
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1])
Normal Low Range
Item
Normal Low Range
text
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Normal High Range
Item
Normal High Range
text
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0587081 (UMLS CUI [1])
Item Group
Serious Adverse Events - Investigational Products
C1519255 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C0013230 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
Code List
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown (U)
CL Item
Not applicable (X)
Item Group
Serious Adverse Events - General narrative comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
General narrative comments
Item
General narrative comments
text
C0947611 (UMLS CUI [1])
Item Group
Serious Adverse Events - Non clinical
C1519255 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
Item
Send incomplete SAE data to GSK Safety
integer
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
Code List
Send incomplete SAE data to GSK Safety
CL Item
Incomplete SAE (3)
Receipt by GSK date
Item
Receipt by GSK date
datetime
C2985846 (UMLS CUI [1])
Was the event serious?
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
SAE Sequence Number
Item
SAE Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number
text
C0333052 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Case ID
Item
Case ID
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code
text
C0805701 (UMLS CUI [1])
Email Flag
Item
Email Flag
text
C0013849 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Sequence number
Item
Sequence number
integer
C2348184 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826819 (UMLS CUI [1])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Unit Dose
Item
Unit Dose
text
C0869039 (UMLS CUI [1])
Item
Units
integer
C1519795 (UMLS CUI [1])
Code List
Units
CL Item
Actuation  (1)
CL Item
Ampoule  (2)
CL Item
Application  (3)
CL Item
Area under curve  (4)
CL Item
Bottle  (5)
CL Item
Capsule  (6)
CL Item
Cubic centimeter  (7)
CL Item
Cup  (8)
CL Item
Gamma per kilogram per minute (9)
CL Item
Gram  (10)
CL Item
Drops  (11)
CL Item
100 International units/ml (12)
CL Item
Inhalation  (13)
CL Item
International units (14)
CL Item
International units per kilogram (15)
CL Item
International units per kilogram per hour  (16)
CL Item
International units per millilitre  (17)
CL Item
Litre (18)
CL Item
Lozenge  (19)
CL Item
Litre per minute  (20)
CL Item
Minimum alveolar concentration  (21)
CL Item
Mega becquerels (MBq) MBQ  (22)
CL Item
Microgram (MCG) (23)
CL Item
Micrograms per hour  (24)
CL Item
Microgram/kilogram  (25)
CL Item
Microgram/kilogram per minute  (26)
CL Item
Micrograms per minute  (27)
CL Item
Micrograms per millitre  (28)
CL Item
Microlitre  (29)
CL Item
Milliequivalent  (30)
CL Item
Milliequivalent per 24  (31)
CL Item
Milligram  (32)
CL Item
Milligram per day  (33)
CL Item
Milligram per hour  (34)
CL Item
Milligram/kilogram  (35)
CL Item
Milligram/kilogram per hour  (36)
CL Item
Milligram/kilogram per minute  (37)
CL Item
Milligram/metre squared  (38)
CL Item
Milligram/millilitre  (39)
CL Item
Milligrams percent  (40)
CL Item
Million international units  (41)
CL Item
Millilitre  (42)
CL Item
Millilitre per hour  (43)
CL Item
Millilitre per minute  (44)
CL Item
Millimole  (45)
CL Item
Megaunits (million units)  (46)
CL Item
Nebule  (47)
CL Item
Ounce  (48)
CL Item
Patch  (49)
CL Item
Percent  (50)
CL Item
Puff  (51)
CL Item
Sachet  (52)
CL Item
Spray  (53)
CL Item
Suppository  (54)
CL Item
Tablet (55)
CL Item
Tablespoon  (56)
CL Item
Teaspoon  (57)
CL Item
Microgram (UG)  (58)
CL Item
Units per hour  (59)
CL Item
Units per kilogram per minute  (60)
CL Item
Units per minute  (61)
CL Item
Units  (62)
CL Item
Unknown  (63)
CL Item
Vial  (64)
Item
Frequency
integer
C3476109 (UMLS CUI [1])
Code List
Frequency
CL Item
2 times per week  (1)
CL Item
3 times per week  (2)
CL Item
4 times per week  (3)
CL Item
5 times per day  (4)
CL Item
5 times per week  (5)
CL Item
AC  (6)
CL Item
BID  (7)
CL Item
Continuous infusion  (8)
CL Item
HS  (9)
CL Item
Once daily  (10)
CL Item
Once only (11)
CL Item
PC  (12)
CL Item
PRN  (13)
CL Item
Q12H  (14)
CL Item
Q2H  (15)
CL Item
Every 2 weeks  (16)
CL Item
Q3D  (17)
CL Item
Every 3 months  (18)
CL Item
Every 3 weeks  (19)
CL Item
Q4D  (20)
CL Item
Q4H  (21)
CL Item
Q6H  (22)
CL Item
Q8H  (23)
CL Item
QAM  (24)
CL Item
QH  (25)
CL Item
QID  (26)
CL Item
Once a month  (27)
CL Item
Every other day  (28)
CL Item
QPM  (29)
CL Item
Once a week  (30)
CL Item
TID  (31)
CL Item
Unknown (32)
Item
Route
integer
C0013153 (UMLS CUI [1])
Code List
Route
CL Item
Epidural (1)
CL Item
Gastrostomy tube (2)
CL Item
Intra-arterial  (3)
CL Item
Intra-articular  (4)
CL Item
Intra-bursa (5)
CL Item
Intradermal  (6)
CL Item
Inhalation  (7)
CL Item
Intralesional (8)
CL Item
Intramuscular (9)
CL Item
Intranasal (10)
CL Item
Injection (11)
CL Item
Intraocular (12)
CL Item
Intraosteal (13)
CL Item
Intraperitoneal (14)
CL Item
Intrathecal (15)
CL Item
Intrauterine (16)
CL Item
Intravenous (17)
CL Item
Nasogastric (18)
CL Item
Nasal (19)
CL Item
Right eye (20)
CL Item
Ophthalmic  (21)
CL Item
Left eye (22)
CL Item
Otic (23)
CL Item
Other (24)
CL Item
Both eyes (25)
CL Item
Oral (26)
CL Item
Rectal (27)
CL Item
Subcutaneous (28)
CL Item
Sublingual (29)
CL Item
Transdermal (30)
CL Item
Topical (31)
CL Item
Unknown (32)
CL Item
Vaginal (33)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication Start Date and Time
Item
Medication Start Date and Time
datetime
C2826734 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Medication taken Prior to Study?
Item
Medication taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant medication ongoing?
Item
Concomitant medication ongoing?
boolean
C2826666 (UMLS CUI [1])
End date and time of concomitant medication
Item
End date and time of concomitant medication
datetime
C2826744 (UMLS CUI [1])
C1522314 (UMLS CUI [2])
Item Group
Urinalysis - Local
C0042014 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Item
Result of Dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Result of Dipstick
CL Item
No Result (NR)
CL Item
Negative (NEG)
CL Item
Positive (POS)
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
C0430397 (UMLS CUI [1,1])
C2700128 (UMLS CUI [1,2])
Item
Urine Dipstick - Laboratory Test
integer
C0430370 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Code List
Urine Dipstick - Laboratory Test
CL Item
pH (1)
CL Item
Specific Gravity (2)
CL Item
Protein (3)
CL Item
Glucose (4)
CL Item
Ketones (5)
CL Item
WBC (6)
CL Item
RBC (7)
Item
Urine Microscopy - Laboratory Tests
integer
C0430397 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Code List
Urine Microscopy - Laboratory Tests
CL Item
WBC Casts (1)
CL Item
RBC Casts (2)
CL Item
Granular Casts (3)
CL Item
Waxy Casts (4)
Laboratory Test Result - Numeric Result
Item
Laboratory Test Result - Numeric Result
float
C0042014 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Laboratory Test Result - Character Result
Item
Laboratory Test Result - Character Result
text
C0042014 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Laboratory Test Result - No Result
integer
C0042014 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
Code List
Laboratory Test Result - No Result
CL Item
No Result (1)
Item Group
Electronically Transferred Lab Data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Item
Laboratory Test Type
text
C0022885 (UMLS CUI [1])
Code List
Laboratory Test Type
CL Item
Haematology (H)
CL Item
Clinical Chemistry (C)
CL Item
Urinalysis (U)
CL Item
AST/ALT (A)
Date and time sample taken
Item
Date and time sample taken
datetime
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Item Group
Vital signs - Semi-supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
Vital Signs Semi-supine - Actual date/time
Item
Vital Signs Semi-supine - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Item
Vital Signs Semi-supine - Blood pressure
integer
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2])
Code List
Vital Signs Semi-supine - Blood pressure
CL Item
Not done (1)
Vital Signs Semi-supine - Systolic blood pressure
Item
Vital Signs Semi-supine - Systolic blood pressure
integer
C0439565 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
Vital Signs Semi-supine - Diastolic blood pressure
Item
Vital Signs Semi-supine - Diastolic blood pressure
integer
C0439565 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2])
Item
Vital Signs Semi-supine - Temperature
integer
C0439565 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0005903 (UMLS CUI [2])
Code List
Vital Signs Semi-supine - Temperature
CL Item
Not done (1)
Vital Signs Semi-supine - Temperature
Item
Vital Signs Semi-supine - Temperature
float
C0439565 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0005903 (UMLS CUI [2])
Item
Vital Signs Semi-supine - Heart rate
integer
C0439565 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0018810 (UMLS CUI [2])
Code List
Vital Signs Semi-supine - Heart rate
CL Item
Not done (1)
Vital Signs Semi-supine - Heart rate
Item
Vital Signs Semi-supine - Heart rate
integer
C0439565 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0018810 (UMLS CUI [2])
Item
Vital Signs Semi-supine - Respiration rate
integer
C0439565 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0231832 (UMLS CUI [2])
Code List
Vital Signs Semi-supine - Respiration rate
CL Item
Not done (1)
Vital Signs Semi-supine - Respiration rate
Item
Vital Signs Semi-supine - Respiration rate
integer
C0439565 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0231832 (UMLS CUI [2])
Item Group
Vital Signs - Standing
C0518766 (UMLS CUI-1)
C0231472 (UMLS CUI-2)
Vital Signs Standing - Actual time
Item
Vital Signs Standing - Actual time
time
C0518766 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2])
Vital Signs Standing - Systolic Blood Pressure
Item
Vital Signs Standing - Systolic Blood Pressure
integer
C0518766 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
Vital Signs Standing - Diastolic Blood Pressure
Item
Vital Signs Standing - Diastolic Blood Pressure
integer
C0518766 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2])
Vital Signs Standing - Heart Rate
Item
Vital Signs Standing - Heart Rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0231472 (UMLS CUI [2])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
C0489636 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc (b) Interval
Item
QTc (b) Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant  (2)
CL Item
(complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
Abnormal - Clinically significant  (3)
CL Item
(complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (5)
CL Item
No result (not available) (4)
Item Group
ECG Abnormalities
C0522055 (UMLS CUI-1)
Item
Lead used for measurement
integer
C1519795 (UMLS CUI [1])
Code List
Lead used for measurement
CL Item
12 Lead ECG (1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Item
Record clinically significant abnormalities - A. Rhythm
text
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0199556 (UMLS CUI [2])
Code List
Record clinically significant abnormalities - A. Rhythm
CL Item
Sinus bradycardia (A1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (A22)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (A23)
CL Item
Sinus pause (A3)
CL Item
Sinus tachycardia (heart rate > 100 beats/min) (A2)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Wandering atrial pacemaker (A17)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (A26)
CL Item
Supraventricular tachycardia (heart rate>100 beats/min) (A6)
CL Item
Atrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Junctional rhythm (heart rate<=100 beats/min) (A5)
CL Item
Junctional rhythm (A25)
CL Item
Junctional tachycardia (heart rate>100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A9)
CL Item
Ventricular couplets (A12)
If other abnormal rhythm, enter comment
Item
If other abnormal rhythm, enter comment
text
C0199556 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item
Record clinically significant abnormalities - B. P-Wave Morphology
text
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C2216025 (UMLS CUI [2])
Code List
Record clinically significant abnormalities - B. P-Wave Morphology
CL Item
Left atrial abnormality (P mitrale) (B1)
CL Item
Right atrial abnormality (P pulmonale) (B2)
CL Item
Right ventricular hypertrophy (B3)
CL Item
Intraatrial conduction delay (B5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology, enter comment (B99)
If other P-Wave Morphology, enter comment
Item
If other P-Wave Morphology, enter comment
text
C2216025 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities - C. Conduction
text
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
Code List
Record clinically significant abnormalities - C. Conduction
CL Item
First degree AV block (PR interval > 200msec) (C1)
CL Item
Short PR interval (C20)
CL Item
Second degree AV block (Mobitz type 1) (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
2:1 AV block (C16)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (C5)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Incomplete left bundle branch block (C13)
CL Item
Right bundle branch block (C8)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
CL Item
Left bundle branch block (C9)
CL Item
Bifascicular block (C17)
CL Item
Non-specific intraventricular conduction delay (QRS > 120 msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
Prolonged QT interval (C19)
CL Item
QT/QTc prolongation > 500 msec (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction, enter comment (C99)
If other conduction, enter comment
Item
If other conduction, enter comment
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities - D. Myocardial infarction
text
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
Code List
Record clinically significant abnormalities - D. Myocardial infarction
CL Item
Myocardial infarction, old (D1)
CL Item
Myocardial infarction, anterior (D2)
CL Item
Myocardial infarction, lateral (D3)
CL Item
Myocardial infarction, posterior (D4)
CL Item
Myocardial infarction, inferior (D5)
CL Item
Myocardial infarction, septal (D6)
CL Item
Myocardial infarction, Non Q-wave (D20)
CL Item
Other myocardial infarction, enter comment (D98)
If other myocardial infarction, enter comment.
Item
If other myocardial infarction, enter comment.
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
Record clinically significant abnormalities - E. Depolarisation/Repolarisation (QRS-T) +
text
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1331539 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
Code List
Record clinically significant abnormalities - E. Depolarisation/Repolarisation (QRS-T) +
CL Item
Non-specific ST-T changes (D7)
CL Item
J point elevation (D19)
CL Item
ST elevation (D8)
CL Item
ST-elevation - pericarditis (D21)
CL Item
ST depression (D9)
CL Item
U waves abnormal (D10)
CL Item
T wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
Notched T-waves (D18)
CL Item
Low QRS voltage (D13)
CL Item
T-wave flattening/inversion (D17)
CL Item
Other depolarisation/repolarisation, enter  (D99)
CL Item
comment (comment)
If other depololarisation/repolarisation, enter comment
Item
If other depololarisation/repolarisation, enter comment
text
C1331539 (UMLS CUI [1,1])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
If other abnormalities, enter comment
Item
If other abnormalities, enter comment
text
C0522055 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Repeat Pharmacokinetics Blood - GSK618334
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])

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