ID
29524
Description
Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: Serious Adverse Event
Keywords
Versions (2)
- 3/4/18 3/4/18 -
- 4/5/18 4/5/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 5, 2018
DOI
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License
Creative Commons BY-NC 3.0
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GSK Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) NCT01009463
Serious Adverse Event
- StudyEvent: ODM
Description
Intensity Changes
Alias
- UMLS CUI-1
- C1710066
- UMLS CUI-2
- C0518690
- UMLS CUI-3
- C1519255
Description
Serious Adverse Event
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Start Date of event segment
Data type
date
Alias
- UMLS CUI [1]
- C2697888
Description
Start Time of event segment
Data type
time
Alias
- UMLS CUI [1]
- C2697889
Description
Intensity of event segment
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
Description
Grade of event segment
Data type
integer
Alias
- UMLS CUI [1]
- C2985911
Description
Grade or Intensity of event segment
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C2985911
Description
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Description
Unit
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1519795
Description
Frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Drug Type
Data type
text
Alias
- UMLS CUI [1]
- C0457591
Description
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
eg. 500 mg
Data type
float
Alias
- UMLS CUI [1]
- C2348070
Description
Primary Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C0011900
Description
start date of medication
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
End Date of medication
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
If a medication was marked ‘Continuing’ at a previous visit, but has since had a dosage change or has been stopped, it must be recorded as a change below with the new start and end date.
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Relevant medical conditions/Risk factors
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Description
Specific Condition name
Data type
text
Alias
- UMLS CUI [1]
- C0012634
Description
Date of onset
Data type
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Description
Continuing?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Description
date of last occurrence
Data type
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
Description
Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0456984
Description
Normal High Range
Data type
text
Alias
- UMLS CUI [1]
- C0086715
Description
Relevant diagnostic results not noted above
Data type
text
Alias
- UMLS CUI [1]
- C0587081
Description
Test Name
Data type
text
Alias
- UMLS CUI [1]
- C0022885
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
text
Alias
- UMLS CUI [1]
- C0086715
Description
Rechallenge
Alias
- UMLS CUI-1
- C2347900
- UMLS CUI-2
- C0304229
Description
event recur after investigational products were restarted
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
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
integer
Alias
- UMLS CUI [1,1]
- C0237125
- UMLS CUI [1,2]
- C0304229
Similar models
Serious Adverse Event
- StudyEvent: ODM
C0304229 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0518690 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C2985911 (UMLS CUI [2])
C1519795 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0574845 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0456984 (UMLS CUI-2)
C0587081 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])