ID
29524
Beschrijving
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
Trefwoorden
Versies (2)
- 04-03-18 04-03-18 -
- 05-04-18 05-04-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
5 april 2018
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Intensity Changes
Alias
- UMLS CUI-1
- C1710066
- UMLS CUI-2
- C0518690
- UMLS CUI-3
- C1519255
Beschrijving
Serious Adverse Event
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Start Date of event segment
Datatype
date
Alias
- UMLS CUI [1]
- C2697888
Beschrijving
Start Time of event segment
Datatype
time
Alias
- UMLS CUI [1]
- C2697889
Beschrijving
Intensity of event segment
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
Beschrijving
Grade of event segment
Datatype
integer
Alias
- UMLS CUI [1]
- C2985911
Beschrijving
Grade or Intensity of event segment
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C2985911
Beschrijving
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1519795
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Drug Type
Datatype
text
Alias
- UMLS CUI [1]
- C0457591
Beschrijving
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
eg. 500 mg
Datatype
float
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
Primary Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C0011900
Beschrijving
start date of medication
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
End Date of medication
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Relevant medical conditions/Risk factors
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Beschrijving
Specific Condition name
Datatype
text
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Date of onset
Datatype
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Beschrijving
Continuing?
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beschrijving
date of last occurrence
Datatype
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
Beschrijving
Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0456984
Beschrijving
Normal High Range
Datatype
text
Alias
- UMLS CUI [1]
- C0086715
Beschrijving
Relevant diagnostic results not noted above
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Test Name
Datatype
text
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Test Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826247
Beschrijving
Test Result
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Test Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beschrijving
Normal Low Range
Datatype
text
Alias
- UMLS CUI [1]
- C0086715
Beschrijving
Rechallenge
Alias
- UMLS CUI-1
- C2347900
- UMLS CUI-2
- C0304229
Beschrijving
event recur after investigational products were restarted
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
Beschrijving
Investigational product
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Study Drug
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
stop date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschrijving
Regimen
Datatype
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])