ID
33172
Description
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma
Keywords
Versions (2)
- 11/2/18 11/2/18 -
- 11/30/18 11/30/18 -
Copyright Holder
GSK group of companies
Uploaded on
November 30, 2018
DOI
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License
Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837
Initial Serious Adverse Event Form
- StudyEvent: ODM
Description
Serious Adverse Event Entry
Alias
- UMLS CUI-1
- C1519255
Description
Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2697888
Description
Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Description
if FATAL, Date of Death
Data type
date
Alias
- UMLS CUI [1,1]
- C2697886
- UMLS CUI [1,2]
- C1519255
Description
Maximum Intensity of Serious Adverse Event
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
Intensity at onset of event
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0332162
Description
Maximum Grade
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806909
- UMLS CUI [1,3]
- C0441800
Description
Grade at onset of event
Data type
integer
Alias
- UMLS CUI [1,1]
- C0806909
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0332162
Description
Record maximum grade or intensity throughout duration of event
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0441800
- UMLS CUI [1,4]
- C0806909
Description
Record grade of intensity at the onset of the event
Data type
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0332162
Description
Action taken with Investigational Product(s) as a result of AE?
Data type
integer
Alias
- UMLS CUI [1]
- C2826626
Description
Did the subject withdraw from the study as a result of AE?
Data type
boolean
Alias
- UMLS CUI [1]
- C0422727
- UMLS CUI [2]
- C1519255
Description
Use best judgement at initial entry. May be amended when additional information becomes available.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1518404
Description
HH:MM
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Description
Time to Onset since last Dose
Data type
time
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C1517741
Description
Was the SAE caused by activities related to study participation other than investigational product (e.g., procedures, blood draws, washout, etc)?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [2,1]
- C2603343
- UMLS CUI [2,2]
- C0679823
- UMLS CUI [3]
- C0304229
- UMLS CUI [4]
- C2700391
- UMLS CUI [5]
- C0005834
- UMLS CUI [6]
- C1710661
Description
Was the event serious?
Data type
boolean
Alias
- UMLS CUI [1]
- C1710056
Description
Related Investigational Product
Data type
text
Alias
- UMLS CUI [1]
- C0304229
Description
Seriousness
Alias
- UMLS CUI-1
- C1710056
Description
Relevant Concomitant/Treatment Medication
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0013227
Description
Iclude any details of any medication that may help explain the SAE, may have caused the SAE or was used to treat the SAE.
Data type
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Description
Enter drug name, not description (Generic name preferred. If combination product, enter Trade Name).
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Modified reported term
Data type
text
Alias
- UMLS CUI [1]
- C2826819
Description
Dose
Data type
float
Alias
- UMLS CUI [1]
- C3174092
Description
Unit
Data type
text
Alias
- UMLS CUI [1]
- C2826646
Description
Frequency
Data type
integer
Alias
- UMLS CUI [1]
- C3476109
Description
Medication Route
Data type
integer
Alias
- UMLS CUI [1]
- C0013153
Description
Medication Start Date
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Is medication ongoing?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
If NO, specify End Date
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
Enter a medical diagnosis not description
Data type
text
Alias
- UMLS CUI [1]
- C2826696
Description
Modified reported term
Data type
text
Alias
- UMLS CUI [1]
- C2826819
Description
Drug Type
Data type
text
Alias
- UMLS CUI [1]
- C0457591
Description
Relevant Medical Conditions/Risk Factors
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0035648
Description
MHx Sequence Number
Data type
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Description
Enter a medical diagnosis not description.
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Modified reported term
Data type
text
Alias
- UMLS CUI [1]
- C2826923
Description
Date of onset
Data type
date
Alias
- UMLS CUI [1]
- C0574845
Description
Continuing?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Description
If NO, specify date of last occurrence
Data type
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Description
Relevant Diagnosis Results
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0456984
Description
Provide details of any tests or procedures carried out to diagnose the SAE.
Data type
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Description
Test Name
Data type
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0027365
Description
Test Date
Data type
date
Alias
- UMLS CUI [1]
- C2826247
Description
Test Result
Data type
text
Alias
- UMLS CUI [1]
- C0587081
Description
Test Units
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Description
Normal Low Range
Data type
integer
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Description
Normal High Range
Data type
integer
Alias
- UMLS CUI [1,1]
- C0205251
- UMLS CUI [1,2]
- C0205250
Description
Relevant diagnostic results not noted above
Data type
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0205394
Description
Rechallenge
Alias
- UMLS CUI-1
- C2347900
Description
If the investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C2745955
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
Study Drug
Data type
text
Alias
- UMLS CUI [1]
- C0304229
Description
Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
Stop Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
Regimen
Data type
text
Alias
- UMLS CUI [1]
- C1276413
Description
General narrative comments
Alias
- UMLS CUI-1
- C0947611
Description
Non Clinical
Alias
- UMLS CUI-1
- C0205210
- UMLS CUI-2
- C1298908
Description
Send incomplete SAE data to GSK Safety
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Description
Receipt by GSK date
Data type
date
Alias
- UMLS CUI [1]
- C2985846
Description
Was the event serious?
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
SAE Sequence number
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Version Number
Data type
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Description
Case ID
Data type
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Description
Randomisation Number
Data type
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
OCEANS Code
Data type
text
Alias
- UMLS CUI [1]
- C0805701
Similar models
Initial Serious Adverse Event Form
- StudyEvent: ODM
C0304229 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C2697888 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
C0441800 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,2])
C2603343 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3])
C2700391 (UMLS CUI [4])
C0005834 (UMLS CUI [5])
C1710661 (UMLS CUI [6])
C0013227 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C0035648 (UMLS CUI-2)
C0262926 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0456984 (UMLS CUI-2)
C2348184 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])