ID

32504

Descripción

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

Palabras clave

Versiones (2)
  1. 5/11/18 5/11/18 -
  2. 6/12/18 6/12/18 -
Titular de derechos de autor

GSK group of companies

Subido en

5 de noviembre de 2018

DOI

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Licencia

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

Inglés

IP Device Malfunction Data

1 formularios  
IP Device Malfunction
Descripción

IP Device Malfunction

Investigation Product Container Number
Descripción

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

Tipo de datos

text

Mark all applicable reasons for this device
Descripción

Mark all applicable reasons for this device

Mouthpiece cover does not stay at the fully actuated position
Descripción

Mouthpiece cover does not stay at the fully actuated position

Tipo de datos

boolean

Mouthpiece cover came apart from the mechanism
Descripción

Mouthpiece cover came apart from the mechanism

Tipo de datos

boolean

Inhaler is cracked or broken apart
Descripción

Inhaler is cracked or broken apart

Tipo de datos

boolean

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

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

Tipo de datos

boolean

Difficult to close mouthpiece cover
Descripción

Difficult to close mouthpiece cover

Tipo de datos

boolean

Powder fell out prior to use
Descripción

Powder fell out prior to use

Tipo de datos

boolean

No powder came out
Descripción

No powder came out

Tipo de datos

boolean

Device squeaks in operation
Descripción

Device squeaks in operation

Tipo de datos

boolean

Device rattles in operation
Descripción

Device rattles in operation

Tipo de datos

boolean

Dose counter did not count
Descripción

Dose counter did not count

Tipo de datos

boolean

Dose counter is ambiguous
Descripción

Dose counter is ambiguous

Tipo de datos

boolean

Dose counter overcounted
Descripción

Dose counter overcounted

Tipo de datos

boolean

Dose counter undercounted
Descripción

Dose counter undercounted

Tipo de datos

boolean

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

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

Tipo de datos

boolean

Device smelt/bad odour when pack opened
Descripción

Device smelt/bad odour when pack opened

Tipo de datos

boolean

Other, specify
Descripción

Other, specify

Tipo de datos

text

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Similar models

IP Device Malfunction Data

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
IP Device Malfunction
Investigation Product Container Number
Item
Investigation Product Container Number
text
Item Group
Mark all applicable reasons for this device
Mouthpiece cover does not stay at the fully actuated position
Item
Mouthpiece cover does not stay at the fully actuated position
boolean
Mouthpiece cover came apart from the mechanism
Item
Mouthpiece cover came apart from the mechanism
boolean
Inhaler is cracked or broken apart
Item
Inhaler is cracked or broken apart
boolean
Difficult to open mouthpiece cover/force to actuate was too high
Item
Difficult to open mouthpiece cover/force to actuate was too high
boolean
Difficult to close mouthpiece cover
Item
Difficult to close mouthpiece cover
boolean
Powder fell out prior to use
Item
Powder fell out prior to use
boolean
No powder came out
Item
No powder came out
boolean
Device squeaks in operation
Item
Device squeaks in operation
boolean
Device rattles in operation
Item
Device rattles in operation
boolean
Dose counter did not count
Item
Dose counter did not count
boolean
Dose counter is ambiguous
Item
Dose counter is ambiguous
boolean
Dose counter overcounted
Item
Dose counter overcounted
boolean
Dose counter undercounted
Item
Dose counter undercounted
boolean
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
Device smelt/bad odour when pack opened
Item
Device smelt/bad odour when pack opened
boolean
Other, specify
Item
Other, specify
text
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