ID

33701

Description

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 8 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the Serious Adverse Events (SAE). It has to be filled in if a SAE occurs during study.

Link

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Keywords

Versions (3)
  1. 12/20/18 12/20/18 -
  2. 12/20/18 12/20/18 -
  3. 12/21/18 12/21/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 20, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate combination on electrocardiographic parameters in healthy subjects, NCT01209026

English

Serious Adverse Events (SAE)

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Type of report
Description

Type of report

Alias
UMLS CUI-1
C0585733
Initial Report
Description

Item is not required

Data type

boolean

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

Item is not required

Data type

boolean

Alias
UMLS CUI [1]
C1704685
Randomisation
Description

Randomisation

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

Study medication causing SAE

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Serious Adverse Events Entry
Description

Serious Adverse Events Entry

Alias
UMLS CUI-1
C1519255
SAE Sequence Number [hidden]
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
SAE Diagnosis
Description

Diagnosis only (if known) otherwise Sign/Symptom

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Modified term [hidden]
Description

Item is not required

Data type

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym [hidden]
Description

MedDRA synonym

Data type

text

Alias
UMLS CUI [1,1]
C1140263
UMLS CUI [1,2]
C0871468
UMLS CUI [1,3]
C1519255
MedDRA lower level term code [hidden]
Description

MedDRA lower level term code

Data type

text

Alias
UMLS CUI [1]
C3898442
Failed coding [hidden]
Description

Failed coding

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Start date of SAE
Description

day month year. Start time is optional

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Start time of SAE
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Outcome of SAE
Description

Outcome of SAE

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End date of SAE, Date of death
Description

day month year. Please fill in if the SAE is 1) recovered/resolvedor 2) recovered/resolved with sequelae If 3) fatal, please fill in date of death

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C1148348
End time of SAE, Time of death
Description

00:00-23:59 End Time is optional Please fill in if the SAE is 1) recovered/resolvedor 2) recovered/resolved with sequelae If 3) fatal, please fill in time of death

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
UMLS CUI [2]
C1301931
Maximum Intensity of SAE
Description

Item is not required. Optional item: This Item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" Item has been used. Grade 5 Is optional.

Data type

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Maximum Grade [hidden]
Description

Item is not required. Optional item: This Item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" Item has been used. Grade 5 Is optional.

Data type

text

Alias
UMLS CUI [1,1]
C0441800
UMLS CUI [1,2]
C1710066
Maximum Grade or Intensity [hidden]
Description

Item is not required. Optional item: This Item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" Item has been used. Grade 5 Is optional.

Data type

text

Alias
UMLS CUI [1,1]
C0441800
UMLS CUI [1,2]
C1710066
UMLS CUI [2]
C1710056
Action Taken with investigational Product(s) as a Result of the SAE
Description

Action taken with investigational Product(s)

Data type

text

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

Withdrawing as result of SAE

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Description

Investigational product causing SAE

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C1519255
Duration of SAE if < 24 hours (hidden)
Description

hr(s):min(s) Item is not required. If AE start and end time are used this item must be hidden.

Data type

time

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

Hr(s):Min(s) Item is not required. This Item Is optional.

Data type

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1519255
Was SAE caused by activities related to study participation (e.g. procedures)?
Description

Study participation causing SAE

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C1519255
Was the event serious? [hidden]
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Seriousness
Description

Seriousness

Alias
UMLS CUI-1
C1710056
Results in death
Description

Results in death

Data type

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1519255
Is life-threatening
Description

Life-threatening

Data type

boolean

Alias
UMLS CUI [1]
C1517874
Requires hospitalization or prolongation of existing hospitalization
Description

Hospitalization/ prolongation of existing hospitalization

Data type

boolean

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

Results in disability/incapacity

Data type

boolean

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

Congenital anomaly/birth defect

Data type

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
Other
Description

specify within general narrative comment

Data type

boolean

Alias
UMLS CUI [1]
C0205394
Is associated with liver injury and impaired liver function defined as: ALT >= 3xULN, and either total bilirubin >=2xULN or INR > 1.5
Description

Liver injury and impaired liver function, ALT, total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0160390
UMLS CUI [2]
C0086565
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201913
Relevant concomitant/treatment medications Entry
Description

Relevant concomitant/treatment medications Entry

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1519255
CM Sequenz number [hidden]
Description

Item is not required

Data type

text

Alias
UMLS CUI [1]
C2348184
Drug name
Description

(Trade name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Drug Dose
Description

Item is not required

Data type

integer

Alias
UMLS CUI [1,1]
C0869039
UMLS CUI [1,2]
C0013227
Dose unit
Description

Item is not required

Data type

text

Alias
UMLS CUI [1]
C2826646
Frequency
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C0013227
Route
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Date started
Description

day month year. Item is not required

Data type

date

Alias
UMLS CUI [1]
C0808070
Ongoing
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0013227
Primary indication
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1519255
Drug type
Description

Drug type

Data type

text

Alias
UMLS CUI [1,1]
C0457591
UMLS CUI [1,2]
C0013227
Relevant medical conditions/risk factors Entry
Description

Relevant medical conditions/risk factors Entry

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0262926
UMLS CUI-3
C0035648
MHx sequence Number [hidden]
Description

Item is not required

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

day month year. Item is not required

Data type

date

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

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0549178
If no continuing, please specify date of last occurence
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0012634
Relevant medical history/ risk factors not noted above
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C1519255
Relevant diagnostic results Entry
Description

Relevant diagnostic results Entry

Alias
UMLS CUI-1
C0430022
UMLS CUI-2
C0456984
Lab Sequence Number [hidden]
Description

Item is not required

Data type

text

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

day month year

Data type

boolean

Alias
UMLS CUI [1]
C2826247
Test Result
Description

Test Result

Data type

text

Alias
UMLS CUI [1]
C0587081
Test Units
Description

Item is not required

Data type

text

Alias
UMLS CUI [1]
C1519795
Normal Low Range
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C1518030
Normal High Range
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0205250
UMLS CUI [1,3]
C1519815
Relevant diagnostic results not noted above
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0456984
Investigational product
Description

Investigational product

Alias
UMLS CUI-1
C0304229
If investigational product(s) stopped, did one reported event(s) recur fter further investigational product(s) were administered?
Description

Item is not required

Data type

text

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1517331
UMLS CUI [1,4]
C0304229
General narrative comments
Description

General narrative comments

Alias
UMLS CUI-1
C0947611
General narrative comment
Description

General narrative comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Non clinical
Description

Non clinical

Alias
UMLS CUI-1
C0205210
UMLS CUI-2
C1298908
Incomplete SAE [hidden]
Description

Send incomplete SAE data to GSK Safety. Item is not required. This item is optional.

Data type

boolean

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0205257
Receipt by GSK date [hidden]
Description

day month year. Item is not required

Data type

date

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

Item is not required

Data type

text

Alias
UMLS CUI [1]
C1519255
SAE Sequence Number [hidden]
Description

Item is not required

Data type

text

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

Item is not required

Data type

integer

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

Item is not required

Data type

text

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

Item is not required

Data type

text

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

Item is not required

Data type

text

Alias
UMLS CUI [1]
C0805701
Email flag [hidden]
Description

Item is not required

Data type

text

Alias
UMLS CUI [1]
C0013849
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Similar models

Serious Adverse Events (SAE)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Type of report
C0585733 (UMLS CUI-1)
Initial Report
Item
Initial Report
boolean
C0684224 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Follow-Up Report
Item
Follow-Up Report
boolean
C1704685 (UMLS CUI [1])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Item
Did SAE occur after initiation of study medication?
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Study medication causing SAE
Code List
Did SAE occur after initiation of study medication?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Serious Adverse Events Entry
C1519255 (UMLS CUI-1)
SAE Sequence Number
Item
SAE Sequence Number [hidden]
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
SAE Diagnosis
Item
SAE Diagnosis
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Modified term
Item
Modified term [hidden]
text
C2826798 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym [hidden]
text
C1140263 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
MedDRA lower level term code
Item
MedDRA lower level term code [hidden]
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding [hidden]
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Start date of SAE
Item
Start date of SAE
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Start time of SAE
Item
Start time of SAE
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome of SAE
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Outcome of SAE
Code List
Outcome of SAE
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End date of SAE, Date of death
Item
End date of SAE, Date of death
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
End time of SAE, Time of death
Item
End time of SAE, Time of death
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1301931 (UMLS CUI [2])
Item
Maximum Intensity of SAE
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity of SAE
Code List
Maximum Intensity of SAE
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not aplicable (X)
Item
Maximum Grade [hidden]
text
C0441800 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Maximum Grade
Code List
Maximum Grade [hidden]
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 (X)
Item
Maximum Grade or Intensity [hidden]
text
C0441800 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C1710056 (UMLS CUI [2])
Maximum Grade or Intensity
Code List
Maximum Grade or Intensity [hidden]
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 (X)
Item
Action Taken with investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action taken with investigational Product(s)
Code List
Action Taken with investigational Product(s) as a Result of the SAE
CL Item
lnvestigational 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 (X)
Item
Did the subject withdraw from study as a result of this SAE?
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Withdrawing as result of SAE
Code List
Did the subject withdraw from study as a result of this SAE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
text
C0304229 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Investigational product causing SAE
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Duration of SAE
Item
Duration of SAE if < 24 hours (hidden)
time
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
Time to Onset Since Last Dose [hidden]
time
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item
Was SAE caused by activities related to study participation (e.g. procedures)?
text
C1997894 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Study participation causing SAE
Code List
Was SAE caused by activities related to study participation (e.g. procedures)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the event serious? [hidden]
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Event serious
Code List
Was the event serious? [hidden]
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Seriousness
C1710056 (UMLS CUI-1)
Results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Life-threatening
Item
Is life-threatening
boolean
C1517874 (UMLS CUI [1])
Hospitalization/ prolongation of existing hospitalization
Item
Requires hospitalization or prolongation of existing hospitalization
boolean
C0019993 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1])
Liver injury and impaired liver function, ALT, total bilirubin
Item
Is associated with liver injury and impaired liver function defined as: ALT >= 3xULN, and either total bilirubin >=2xULN or INR > 1.5
boolean
C0160390 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
Item Group
Relevant concomitant/treatment medications Entry
C2347852 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
CM Sequenz number
Item
CM Sequenz number [hidden]
text
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name
text
C0013227 (UMLS CUI [1])
Drug Dose
Item
Drug Dose
integer
C0869039 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Dose unit
text
C2826646 (UMLS CUI [1])
Dose unit
Code List
Dose unit
CL Item
Actuation (ACTU)
CL Item
Ampoule (AMP)
CL Item
Application (AP)
CL Item
Bottle (BT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Drops (031)
CL Item
Gram (002)
CL Item
International units (025)
CL Item
International units per kilogram (028)
CL Item
International units per millilitre (IUML)
CL Item
Litre (011)
CL Item
Litre per minute (LM)
CL Item
Lozenge (LOZ)
CL Item
Megaunits (million units) (MEGU)
CL Item
Microgram (UG) (004)
CL Item
Microgram (UG) (004)
CL Item
Microgram/kilogram (008)
CL Item
Microgram/kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Microlitre (013)
CL Item
Milliequivalent (029)
CL Item
Milliequivalent per 24 hours (MEQ24)
CL Item
Milligram (003)
CL Item
Milligrams percent (MGPER)
CL Item
Milligram per hour (MGH)
CL Item
Milligram/kilogram (007)
CL Item
Milligram/kilogram per hour (MGKH)
CL Item
Milligram/kilogram per minute (MGKM)
CL Item
Milligram/metre squared (009)
CL Item
Milligram/millilitre (MGML)
CL Item
Millilitre (012)
CL Item
Millilitre per hour (MLH)
CL Item
Millilitre per minute (MLM)
CL Item
Millimole (023)
CL Item
Million International units (027)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Nebule (NEB)
CL Item
Patch (PAT)
CL Item
Percent (030)
CL Item
Puff (PUFF)
CL Item
Sachet (SAC)
CL Item
Spray (SPR)
CL Item
Suppository (SUP)
CL Item
Tablespoon (TBS)
CL Item
Tablet (TAB)
CL Item
Teaspoon (TSP)
CL Item
Units (UNT)
CL Item
Unknown (U)
CL Item
Vial (VIA)
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Frequency
Code List
Frequency
CL Item
2 times per week (2W)
CL Item
3 times per week (3W)
CL Item
4 times per week (4W)
CL Item
5 times per day (5D)
CL Item
5 times per week (5W)
CL Item
AC (AC)
CL Item
Q12H (2D)
CL Item
Continuous infusion (CO)
CL Item
Every 2 weeks (FO)
CL Item
Every 3 weeks (Q3WK)
CL Item
Every 3 months (Q3M)
CL Item
Every other day (AD)
CL Item
QPM (1N)
CL Item
Once a month (MO)
CL Item
Once aweek (WE)
CL Item
Once daily (1D)
CL Item
Once only (1S)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q2H (12D)
CL Item
Q3D (Q3D)
CL Item
Q4D (Q4D)
CL Item
Q4H (6D)
CL Item
QID (4D)
CL Item
TID (3D)
CL Item
Q12H (2D)
CL Item
QAM (1M)
CL Item
QH (24D)
CL Item
QID (4D)
CL Item
QPM (1N)
CL Item
TID (3D)
CL Item
Unknown (U)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Both eyes (047)
CL Item
Epidural (008)
CL Item
Gastrostomy tube (GT)
CL Item
Inhalation (055)
CL Item
Injection (INJ)
CL Item
Intra-arterial (013)
CL Item
Intra-bursa (IBU)
CL Item
Intralesional (026)
CL Item
Intramuscular (030)
CL Item
Nasal (045)
CL Item
Intraocular (031)
CL Item
lntraosteal (IOS)
CL Item
Intraperitoneal (033)
CL Item
Intrathecal (037)
CL Item
Intrauterine (015)
CL Item
Intravenous (042)
CL Item
Nasal (045)
CL Item
Oral (048)
CL Item
Rectal (054)
CL Item
Subcutaneous (058)
CL Item
Subtingual (060)
CL Item
Topical (061)
CL Item
Transdermal (062)
CL Item
Unknown (065)
CL Item
Vaginal (067)
Date started
Item
Date started
date
C0808070 (UMLS CUI [1])
Item
Ongoing
text
C0549178 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Ongoing
Code List
Ongoing
CL Item
Yes (Y)
CL Item
No (N)
Primary indication
Item
Primary indication
text
C3146298 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Drug type
text
C0457591 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Drug type
Code List
Drug type
CL Item
Cause of SAE (1)
CL Item
Concomitant (2)
CL Item
Treatment (T)
Item Group
Relevant medical conditions/risk factors Entry
C0012634 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
MHx sequence Number
Item
MHx sequence Number [hidden]
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
date
C0574845 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item
Continuing?
text
C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Continuing
Code List
Continuing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Date of last occurence
Item
If no continuing, please specify date of last occurence
date
C2745955 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
Relevant medical history/ risk factors
Item
Relevant medical history/ risk factors not noted above
text
C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item Group
Relevant diagnostic results Entry
C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
Lab Sequence Number
Item
Lab Sequence Number [hidden]
text
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Test Name
integer
C0022885 (UMLS CUI [1])
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
Blllrubln 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
CDS lymphocytes (17)
CL Item
Chloride (18)
CL Item
Cholesterol total (19)
CL Item
C-reactlve 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
FEV1 (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
pC02 (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
boolean
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])
C1518030 (UMLS CUI [1,3])
Normal High Range
Item
Normal High Range
text
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
Relevant diagnostic results
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Item Group
Investigational product
C0304229 (UMLS CUI-1)
Item
If investigational product(s) stopped, did one reported event(s) recur fter further investigational product(s) were administered?
text
C0034897 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Recurrence of Adverse event after further investigational product
Code List
If investigational product(s) stopped, did one reported event(s) recur fter further investigational product(s) were administered?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
General narrative comments
C0947611 (UMLS CUI-1)
General narrative comment
Item
General narrative comment
text
C0947611 (UMLS CUI [1])
Item Group
Non clinical
C0205210 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
Incomplete SAE
Item
Incomplete SAE [hidden]
boolean
C1710056 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
Receipt by GSK date
Item
Receipt by GSK date [hidden]
date
C2985846 (UMLS CUI [1])
Item
Was the event serious? [hidden]
text
C1519255 (UMLS CUI [1])
Event serious
Code List
Was the event serious? [hidden]
CL Item
Yes (Y)
CL Item
No (N)
SAE Sequence Number
Item
SAE Sequence Number [hidden]
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
Version Number [hidden]
integer
C0333052 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Case ID
Item
Case ID [hidden]
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number [hidden]
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
OCEANS Code [hidden]
text
C0805701 (UMLS CUI [1])
Email flag
Item
Email flag [hidden]
text
C0013849 (UMLS CUI [1])
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