ID

33356

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)
  1. 11/5/18 11/5/18 -
  2. 12/6/18 12/6/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 6, 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

English

IP Device Malfunction Data

1 forms  
IP Device Malfunction
Description

IP Device Malfunction

Alias
UMLS CUI-1
C1881681
Investigation Product Container Number
Description

Complete a new form for each device that malfunctioned during the study

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Mark all applicable reasons for this device
Description

Mark all applicable reasons for this device

Alias
UMLS CUI-1
C1881681
UMLS CUI-2
C0392360
Mouthpiece cover does not stay at the fully actuated position
Description

Mouthpiece cover does not stay at the fully actuated position

Data type

boolean

Alias
UMLS CUI [1,1]
C1572267
UMLS CUI [1,2]
C3888055
UMLS CUI [1,3]
C1550045
Mouthpiece cover came apart from the mechanism
Description

Mouthpiece cover came apart from the mechanism

Data type

boolean

Alias
UMLS CUI [1,1]
C1572267
UMLS CUI [1,2]
C3888055
UMLS CUI [1,3]
C0441712
Inhaler is cracked or broken apart
Description

Inhaler is cracked or broken apart

Data type

boolean

Alias
UMLS CUI [1,1]
C0021461
UMLS CUI [1,2]
C1706353
Difficult to open mouthpiece cover/force to actuate was too high
Description

Difficult to open mouthpiece cover/force to actuate was too high

Data type

boolean

Alias
UMLS CUI [1,1]
C1572267
UMLS CUI [1,2]
C3888055
UMLS CUI [1,3]
C0332218
UMLS CUI [1,4]
C0175566
Difficult to close mouthpiece cover
Description

Difficult to close mouthpiece cover

Data type

boolean

Alias
UMLS CUI [1,1]
C1572267
UMLS CUI [1,2]
C3888055
UMLS CUI [1,3]
C0332218
UMLS CUI [1,4]
C3810854
Powder fell out prior to use
Description

Powder fell out prior to use

Data type

boolean

Alias
UMLS CUI [1,1]
C0991575
UMLS CUI [1,2]
C0439787
No powder came out
Description

No powder came out

Data type

boolean

Alias
UMLS CUI [1,1]
C0991575
UMLS CUI [1,2]
C0439787
Device squeaks in operation
Description

Device squeaks in operation

Data type

boolean

Alias
UMLS CUI [1,1]
C0699733
UMLS CUI [1,2]
C0028263
Device rattles in operation
Description

Device rattles in operation

Data type

boolean

Alias
UMLS CUI [1,1]
C0699733
UMLS CUI [1,2]
C0028263
Dose counter did not count
Description

Dose counter did not count

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
Dose counter is ambiguous
Description

Dose counter is ambiguous

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0332241
Dose counter overcounted
Description

Dose counter overcounted

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0205136
UMLS CUI [1,4]
C0750480
Dose counter undercounted
Description

Dose counter undercounted

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0439092
Difficult to pull air through the device as described in the leaflet
Description

Difficult to pull air through the device as described in the leaflet

Data type

boolean

Alias
UMLS CUI [1,1]
C0332218
UMLS CUI [1,2]
C3536832
UMLS CUI [1,3]
C0699733
Device smelt/bad odour when pack opened
Description

Device smelt/bad odour when pack opened

Data type

boolean

Alias
UMLS CUI [1,1]
C0699733
UMLS CUI [1,2]
C0037361
Other, specify
Description

Other, specify

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
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Similar models

IP Device Malfunction Data

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
IP Device Malfunction
C1881681 (UMLS CUI-1)
Investigation Product Container Number
Item
Investigation Product Container Number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
Mark all applicable reasons for this device
C1881681 (UMLS CUI-1)
C0392360 (UMLS CUI-2)
Mouthpiece cover does not stay at the fully actuated position
Item
Mouthpiece cover does not stay at the fully actuated position
boolean
C1572267 (UMLS CUI [1,1])
C3888055 (UMLS CUI [1,2])
C1550045 (UMLS CUI [1,3])
Mouthpiece cover came apart from the mechanism
Item
Mouthpiece cover came apart from the mechanism
boolean
C1572267 (UMLS CUI [1,1])
C3888055 (UMLS CUI [1,2])
C0441712 (UMLS CUI [1,3])
Inhaler is cracked or broken apart
Item
Inhaler is cracked or broken apart
boolean
C0021461 (UMLS CUI [1,1])
C1706353 (UMLS CUI [1,2])
Difficult to open mouthpiece cover/force to actuate was too high
Item
Difficult to open mouthpiece cover/force to actuate was too high
boolean
C1572267 (UMLS CUI [1,1])
C3888055 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
C0175566 (UMLS CUI [1,4])
Difficult to close mouthpiece cover
Item
Difficult to close mouthpiece cover
boolean
C1572267 (UMLS CUI [1,1])
C3888055 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
C3810854 (UMLS CUI [1,4])
Powder fell out prior to use
Item
Powder fell out prior to use
boolean
C0991575 (UMLS CUI [1,1])
C0439787 (UMLS CUI [1,2])
No powder came out
Item
No powder came out
boolean
C0991575 (UMLS CUI [1,1])
C0439787 (UMLS CUI [1,2])
Device squeaks in operation
Item
Device squeaks in operation
boolean
C0699733 (UMLS CUI [1,1])
C0028263 (UMLS CUI [1,2])
Device rattles in operation
Item
Device rattles in operation
boolean
C0699733 (UMLS CUI [1,1])
C0028263 (UMLS CUI [1,2])
Dose counter did not count
Item
Dose counter did not count
boolean
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Dose counter is ambiguous
Item
Dose counter is ambiguous
boolean
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0332241 (UMLS CUI [1,3])
Dose counter overcounted
Item
Dose counter overcounted
boolean
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0205136 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,4])
Dose counter undercounted
Item
Dose counter undercounted
boolean
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0439092 (UMLS CUI [1,3])
Difficult to pull air through the device as described in the leaflet
Item
Difficult to pull air through the device as described in the leaflet
boolean
C0332218 (UMLS CUI [1,1])
C3536832 (UMLS CUI [1,2])
C0699733 (UMLS CUI [1,3])
Device smelt/bad odour when pack opened
Item
Device smelt/bad odour when pack opened
boolean
C0699733 (UMLS CUI [1,1])
C0037361 (UMLS CUI [1,2])
Other, specify
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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