ID
29524
Beschreibung
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
Stichworte
Versionen (2)
- 04.03.18 04.03.18 -
- 05.04.18 05.04.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
5. April 2018
DOI
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Lizenz
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
Beschreibung
Intensity Changes
Alias
- UMLS CUI-1
- C1710066
- UMLS CUI-2
- C0518690
- UMLS CUI-3
- C1519255
Beschreibung
Serious Adverse Event
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Start Date of event segment
Datentyp
date
Alias
- UMLS CUI [1]
- C2697888
Beschreibung
Start Time of event segment
Datentyp
time
Alias
- UMLS CUI [1]
- C2697889
Beschreibung
Intensity of event segment
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
Beschreibung
Grade of event segment
Datentyp
integer
Alias
- UMLS CUI [1]
- C2985911
Beschreibung
Grade or Intensity of event segment
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C2985911
Beschreibung
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Unit
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1519795
Beschreibung
Frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Drug Type
Datentyp
text
Alias
- UMLS CUI [1]
- C0457591
Beschreibung
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Datentyp
text
Alias
- UMLS CUI [1]
- C2360065
Beschreibung
eg. 500 mg
Datentyp
float
Alias
- UMLS CUI [1]
- C2348070
Beschreibung
Primary Indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C0011900
Beschreibung
start date of medication
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
End Date of medication
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Relevant medical conditions/Risk factors
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Beschreibung
Specific Condition name
Datentyp
text
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
Date of onset
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Beschreibung
Continuing?
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beschreibung
date of last occurrence
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
Beschreibung
Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0456984
Beschreibung
Normal High Range
Datentyp
text
Alias
- UMLS CUI [1]
- C0086715
Beschreibung
Relevant diagnostic results not noted above
Datentyp
text
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Test Name
Datentyp
text
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Test Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826247
Beschreibung
Test Result
Datentyp
text
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Test Units
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beschreibung
Normal Low Range
Datentyp
text
Alias
- UMLS CUI [1]
- C0086715
Beschreibung
Rechallenge
Alias
- UMLS CUI-1
- C2347900
- UMLS CUI-2
- C0304229
Beschreibung
event recur after investigational products were restarted
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
Beschreibung
Investigational product
Alias
- UMLS CUI-1
- C0304229
Beschreibung
Study Drug
Datentyp
text
Alias
- UMLS CUI [1]
- C0304229
Beschreibung
start date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschreibung
stop date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschreibung
Regimen
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0237125
- UMLS CUI [1,2]
- C0304229
Ähnliche Modelle
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])