ID

33356

Descrição

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

Palavras-chave

Versões (2)
  1. 5/11/18 5/11/18 -
  2. 6/12/18 6/12/18 -
Titular dos direitos

GSK group of companies

Transferido a

6 de diciembre de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

Inglês

IP Device Malfunction Data

1 Formulários  
IP Device Malfunction
Descrição

IP Device Malfunction

Alias
UMLS CUI-1
C1881681
Investigation Product Container Number
Descrição

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

Tipo de dados

text

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

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
Descrição

Mouthpiece cover does not stay at the fully actuated position

Tipo de dados

boolean

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

Mouthpiece cover came apart from the mechanism

Tipo de dados

boolean

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

Inhaler is cracked or broken apart

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

Difficult to close mouthpiece cover

Tipo de dados

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
Descrição

Powder fell out prior to use

Tipo de dados

boolean

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

No powder came out

Tipo de dados

boolean

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

Device squeaks in operation

Tipo de dados

boolean

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

Device rattles in operation

Tipo de dados

boolean

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

Dose counter did not count

Tipo de dados

boolean

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

Dose counter is ambiguous

Tipo de dados

boolean

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

Dose counter overcounted

Tipo de dados

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
Descrição

Dose counter undercounted

Tipo de dados

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
Descrição

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

Tipo de dados

boolean

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

Device smelt/bad odour when pack opened

Tipo de dados

boolean

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

Other, specify

Tipo de dados

text

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

IP Device Malfunction Data

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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