ID

40459

Beschreibung

The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitus Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

Stichworte

Versionen (2)
  1. 23.04.20 23.04.20 -
  2. 07.06.20 07.06.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

23. April 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin

Englisch

Serious Adverse Events - Repeating Form

1 Formulare  
Type of Report
Beschreibung

Type of Report

Alias
UMLS CUI-1
C3897642
UMLS CUI-2
C0332307
Type of Report
Beschreibung

Type of Report

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897642
UMLS CUI [1,2]
C0332307
Randomisation
Beschreibung

Randomisation

Alias
UMLS CUI-1
C0034656
Did SAE occur after initiation of study medication?
Beschreibung

Did SAE occur after initiation of study medication?

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C1704686
Serious Adverse Event Entry
Beschreibung

Serious Adverse Event Entry

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1705654
SAE Sequence Number
Beschreibung

SAE Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event Diagnosis (if known) Otherwise Sign/Symptom
Beschreibung

Diagnosis or Sign/Symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C3540840
Modified Term
Beschreibung

Modified Term

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826798
Start Time and Date
Beschreibung

Start time is optional

Datentyp

partialDatetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
Outcome / End
Beschreibung

Outcome / End

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Outcome / End Date and Time
Beschreibung

End time is optional

Datentyp

partialDatetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
UMLS CUI [1,3]
C2826793
Maximum Intensity
Beschreibung

This item may be hidden if either the "Maxium Grade" or "Maximum Grade or Intensity" item has been used. Grade 5 is optional.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Maximum Grade
Beschreibung

This item may be hidden if either the "Maxium Intensity" or "Maximum Grade or Intensity" item has been used. Grade 5 is optional.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0806909
Maximum Grade or Intensity
Beschreibung

This item may be hidden if either the "Maxium Intensity" or "Maximum Grade" item has been used. Grade 5 is optional.

Datentyp

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
Beschreibung

Action Taken with Investigational Product(s) as a Result of the AE

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this AE?
Beschreibung

Did the subject withdraw from study as a result of this AE?

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1519255
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C1705910
Duration of AE if < 24 hours
Beschreibung

in hours and minutes If AE start and end time are used this item must be hidden.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
Time to Onset Since Last Dose
Beschreibung

in hours and minutes This item is optional.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0946444
UMLS CUI [1,3]
C0449244
Was SAE caused by activities related to study participation (e.g. procedures)?
Beschreibung

SAE caused by activities related to study participation

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0441655
UMLS CUI [1,4]
C2348568
Was the event serious?
Beschreibung

Event Serious

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Seriousness
Beschreibung

Seriousness

Alias
UMLS CUI-1
C1710056
Results in Death
Beschreibung

Results in Death

Datentyp

boolean

Alias
UMLS CUI [1]
C1320832
Is life-threatening
Beschreibung

Is life-threatening

Datentyp

boolean

Alias
UMLS CUI [1]
C1517874
Requires hospitalisation or prolongation of existing hospitalisation
Beschreibung

Requires hospitalisation or prolongation of existing hospitalisation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0745041
Results in disability/incapacity
Beschreibung

Results in disability/incapacity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3176592
UMLS CUI [1,2]
C1519255
UMLS CUI [2,1]
C0231170
UMLS CUI [2,2]
C1519255
Congenital anomaly/birth defect
Beschreibung

Congenital anomaly/birth defect

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
Other, specify within general narrative comment
Beschreibung

Other

Datentyp

float

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C0205394
Relevant Concomitant Treatment/Medications Entry
Beschreibung

Relevant Concomitant Treatment/Medications Entry

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2347946
UMLS CUI-3
C0013227
UMLS CUI-4
C0087111
CM sequence number
Beschreibung

CM: concomitant agent

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C2347852
Drug Name (Trade Name preferred)
Beschreibung

Drug Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0027365
UMLS CUI [2,1]
C0592503
UMLS CUI [2,2]
C0013227
Dose
Beschreibung

Dose

Datentyp

float

Unit
Beschreibung

Unit

Datentyp

integer

Frequency
Beschreibung

Frequency

Datentyp

integer

Alias
UMLS CUI [1,1]
C2826654
UMLS CUI [1,2]
C2347946
UMLS CUI [2,1]
C2347946
UMLS CUI [2,2]
C0013216
UMLS CUI [2,3]
C0439603
Route
Beschreibung

Route

Datentyp

integer

Alias
UMLS CUI [1,1]
C2347946
UMLS CUI [1,2]
C2826730
UMLS CUI [2,1]
C2347946
UMLS CUI [2,2]
C0013216
UMLS CUI [2,3]
C0013153
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2347946
UMLS CUI [1,2]
C2826734
UMLS CUI [2,1]
C0808070
UMLS CUI [2,2]
C2347946
UMLS CUI [2,3]
C0013216
Ongoing?
Beschreibung

Ongoing

Datentyp

integer

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C2347946
UMLS CUI [2,1]
C2347946
UMLS CUI [2,2]
C0013216
UMLS CUI [2,3]
C0549178
Ongoing relevant concomitant/treatment medication End Date
Beschreibung

Ongoing End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C2826744
UMLS CUI [2,1]
C2347946
UMLS CUI [2,2]
C0013216
UMLS CUI [2,3]
C0549178
UMLS CUI [2,4]
C0806020
Primary Indication
Beschreibung

Primary Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C2826696
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C3146298
UMLS CUI [2,3]
C0205225
Drug Type
Beschreibung

Drug Type

Datentyp

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0457591
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0457591
Relevant Medical Conditions/Risk Factors Entry
Beschreibung

Relevant Medical Conditions/Risk Factors Entry

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0262926
UMLS CUI-3
C0035648
UMLS CUI-4
C2347946
MHx Sequence Number
Beschreibung

MHx: Medical History

Datentyp

integer

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

Specific Condition Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0027365
Date of Onset
Beschreibung

Date of Onset

Datentyp

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C0574845
UMLS CUI [2,2]
C0035648
Continuing?
Beschreibung

Continuing?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0549178
Not continuing, date of last occurence
Beschreibung

Not continuing, date of last occurence

Datentyp

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C1517741
UMLS CUI [1,5]
C0011008
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0549178
UMLS CUI [2,3]
C2745955
UMLS CUI [2,4]
C1517741
UMLS CUI [2,5]
C0011008
Relevant Medical History/Risk Factors not noted above
Beschreibung

Relevant Medical History/Risk Factors not noted above

Datentyp

text

Alias
UMLS CUI [1,1]
C2347946
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C2347946
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0035648
Relevant Diagnostic Results Entry
Beschreibung

Relevant Diagnostic Results Entry

Alias
UMLS CUI-1
C2347946
UMLS CUI-2
C0430022
UMLS CUI-3
C0456984
UMLS CUI-4
C1519255
Lab Sequence Number
Beschreibung

Lab Sequence Number

Datentyp

integer

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

Test Name

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C2826273
Test Date
Beschreibung

Test Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0011008
Test Result
Beschreibung

Test Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
Test Units
Beschreibung

Test Units

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0430022
Normal Low Range
Beschreibung

Normal Low Range

Datentyp

float

Alias
UMLS CUI [1,1]
C1272773
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C2347946
Normal High Range
Beschreibung

Normal High Range

Datentyp

float

Alias
UMLS CUI [1,1]
C1519815
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C2347946
Relevant diagnostic results not noted above
Beschreibung

Relevant diagnostic results not noted above

Datentyp

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205394
Investigational Products
Beschreibung

Investigational Products

Alias
UMLS CUI-1
C0013230
If investigational product(s) stopped, did the reported event(s) occur after further investigational product(s) were administered?
Beschreibung

Investigational product(s)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1947925
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C0687676
UMLS CUI [1,5]
C0205394
UMLS CUI [1,6]
C2348003
General Narrative Comments
Beschreibung

General Narrative Comments

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

General narrative comments

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Non Clinical
Beschreibung

Non Clinical

Alias
UMLS CUI-1
C0205210
UMLS CUI-2
C0205160
UMLS CUI-3
C1519255
Send incomplete SAE data to GSK Safety
Beschreibung

This item is optional.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519246
UMLS CUI [1,2]
C0205257
UMLS CUI [1,3]
C1519255
UMLS CUI [1,4]
C1511726
UMLS CUI [1,5]
C2347796
Receipt by GSK date
Beschreibung

Receipt by GSK date

Datentyp

datetime

Alias
UMLS CUI [1,1]
C2985846
UMLS CUI [1,2]
C2347796
Was the event serious?
Beschreibung

Was the event serious?

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1547644
SAE Sequence Number
Beschreibung

SAE Sequence Number

Datentyp

integer

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

Version Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0333052
UMLS CUI [1,3]
C0237753
Case ID
Beschreibung

Case ID

Datentyp

text

Alias
UMLS CUI [1,1]
C0868928
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C1519255
Randomisation Number
Beschreibung

Randomisation Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1519255
OCEANS Code
Beschreibung

OCEANS Code

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C1516728
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Ähnliche Modelle

Serious Adverse Events - Repeating Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Type of Report
C3897642 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
Item
Type of Report
integer
C3897642 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Report
Code List
Type of Report
CL Item
Initial (1)
CL Item
Follow-up (2)
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Item
Did SAE occur after initiation of study medication?
integer
C1519255 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1704686 (UMLS CUI [1,4])
Did SAE occur after initiation of study medication?
Code List
Did SAE occur after initiation of study medication?
CL Item
No (1)
CL Item
Yes (2)
Item Group
Serious Adverse Event Entry
C1519255 (UMLS CUI-1)
C1705654 (UMLS CUI-2)
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Diagnosis or Sign/Symptom
Item
Serious Adverse Event Diagnosis (if known) Otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
Modified Term
Item
Modified Term
text
C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Start Time and Date
Item
Start Time and Date
partialDatetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Outcome / End
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome / End
Code List
Outcome / End
CL Item
Recovered/Resolved (provide End Date and Time in the next question) (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (provide End Date and Time in the next question) (4)
CL Item
Fatal (record Date and Time of Death in the next question) (5)
Outcome / End Date and Time
Item
Outcome / End Date and Time
partialDatetime
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C2826793 (UMLS CUI [1,3])
Item
Maximum Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Maximum Grade
integer
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Maximum Grade
Code List
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
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])
Maximum Grade or Intensity
Code List
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])
Action Taken with Investigational Product(s) as a Result of the AE
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)
Item
Did the subject withdraw from study as a result of this AE?
integer
C1710677 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Did the subject withdraw from study as a result of this AE?
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes, specify End Date in the next question (1)
CL Item
No (2)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
integer
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1705910 (UMLS CUI [1,4])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (1)
CL Item
No (2)
Duration of AE if < 24 hours
Item
Duration of AE if < 24 hours
text
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose
text
C1519255 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
SAE caused by activities related to study participation
Code List
Was SAE caused by activities related to study participation (e.g. procedures)?
CL Item
Yes (1)
CL Item
No (2)
Item
Was the event serious?
integer
C1519255 (UMLS CUI [1])
Did the subject withdraw from study as a result of this AE?
Code List
Was the event serious?
CL Item
Yes, specify End Date in the next question (1)
CL Item
No (2)
Item Group
Seriousness
C1710056 (UMLS CUI-1)
Results in Death
Item
Results in Death
boolean
C1320832 (UMLS CUI [1])
Is life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1])
Requires hospitalisation or prolongation of existing hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C3176592 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0231170 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other
Item
Other, specify within general narrative comment
float
C1710056 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Relevant Concomitant Treatment/Medications Entry
C2347852 (UMLS CUI-1)
C2347946 (UMLS CUI-2)
C0013227 (UMLS CUI-3)
C0087111 (UMLS CUI-4)
CM sequence number
Item
CM sequence number
integer
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug Name
Item
Drug Name (Trade Name preferred)
text
C0013227 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
C0592503 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Dose
Item
Dose
float
Item
Unit
integer
Unit
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
C2826654 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C2347946 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C0439603 (UMLS CUI [2,3])
Frequency
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
C2347946 (UMLS CUI [1,1])
C2826730 (UMLS CUI [1,2])
C2347946 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C0013153 (UMLS CUI [2,3])
Route
Code List
Route
CL Item
Both Eyes (1)
CL Item
Epidural (2)
CL Item
Gastronomy 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)
Start Date
Item
Start Date
date
C2347946 (UMLS CUI [1,1])
C2826734 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0013216 (UMLS CUI [2,3])
Item
Ongoing?
integer
C2826666 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C2347946 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C0549178 (UMLS CUI [2,3])
Did the subject withdraw from study as a result of this AE?
Code List
Ongoing?
CL Item
Yes, specify End Date in the next question (1)
CL Item
No (2)
Ongoing End Date
Item
Ongoing relevant concomitant/treatment medication End Date
date
C2826666 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C2826744 (UMLS CUI [1,3])
C2347946 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C0549178 (UMLS CUI [2,3])
C0806020 (UMLS CUI [2,4])
Primary Indication
Item
Primary Indication
text
C2826696 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0013216 (UMLS CUI [2,1])
C3146298 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
Item
Drug Type
integer
C2347852 (UMLS CUI [1,1])
C0457591 (UMLS CUI [1,2])
C0013216 (UMLS CUI [2,1])
C0457591 (UMLS CUI [2,2])
Drug Type
Code List
Drug Type
CL Item
Concomitant (1)
CL Item
Treatment (2)
CL Item
Cause of SAE (3)
Item Group
Relevant Medical Conditions/Risk Factors Entry
C1519255 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C2347946 (UMLS CUI-4)
MHx Sequence Number
Item
MHx Sequence Number
integer
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])
C0027365 (UMLS CUI [1,3])
Date of Onset
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0574845 (UMLS CUI [2,1])
C0035648 (UMLS CUI [2,2])
Item
Continuing?
integer
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Continuing?
Code List
Continuing?
CL Item
Yes (1)
CL Item
No, specify date of last occurence in the next question (2)
CL Item
Unknown (3)
Not continuing, date of last occurence
Item
Not continuing, date of last occurence
date
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0035648 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
C1517741 (UMLS CUI [2,4])
C0011008 (UMLS CUI [2,5])
Relevant Medical History/Risk Factors not noted above
Item
Relevant Medical History/Risk Factors not noted above
text
C2347946 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C2347946 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
Item Group
Relevant Diagnostic Results Entry
C2347946 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C1519255 (UMLS CUI-4)
Lab Sequence Number
Item
Lab Sequence Number
integer
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Test Name
integer
C0430022 (UMLS CUI [1,1])
C2826273 (UMLS CUI [1,2])
Test Name
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
Blody 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-reaktive 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 concentraion (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
C0430022 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Test Result
Item
Test Result
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Normal Low Range
Item
Normal Low Range
float
C1272773 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
Normal High Range
Item
Normal High Range
float
C1519815 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Investigational Products
C0013230 (UMLS CUI-1)
Item
If investigational product(s) stopped, did the reported event(s) occur after further investigational product(s) were administered?
integer
C0304229 (UMLS CUI [1,1])
C1947925 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C2348003 (UMLS CUI [1,6])
Investigational product(s)
Code List
If investigational product(s) stopped, did the reported event(s) occur after further investigational product(s) were administered?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time (3)
CL Item
No applicable (4)
Item Group
General Narrative Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
General narrative comments
Item
General narrative comments
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Non Clinical
C0205210 (UMLS CUI-1)
C0205160 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Item
Send incomplete SAE data to GSK Safety
integer
C1519246 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C2347796 (UMLS CUI [1,5])
Incomplete SAE to GSK Safety
Code List
Send incomplete SAE data to GSK Safety
CL Item
Incomplete SAE (1)
Receipt by GSK date
Item
Receipt by GSK date
datetime
C2985846 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
Item
Was the event serious?
integer
C1519255 (UMLS CUI [1,1])
C1547644 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Code List
Was the event serious?
CL Item
Yes (1)
CL Item
No (2)
SAE Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number
integer
C1519255 (UMLS CUI [1,1])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Case ID
Item
Case ID
text
C0868928 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
OCEANS Code
Item
OCEANS Code
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
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