ID

32504

Descrizione

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

versioni (2)
  1. 05/11/18 05/11/18 -
  2. 06/12/18 06/12/18 -
Titolare del copyright

GSK group of companies

Caricato su

5 novembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

IP Device Malfunction Data

1 moduli  
IP Device Malfunction
Descrizione

IP Device Malfunction

Investigation Product Container Number
Descrizione

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

Tipo di dati

text

Mark all applicable reasons for this device
Descrizione

Mark all applicable reasons for this device

Mouthpiece cover does not stay at the fully actuated position
Descrizione

Mouthpiece cover does not stay at the fully actuated position

Tipo di dati

boolean

Mouthpiece cover came apart from the mechanism
Descrizione

Mouthpiece cover came apart from the mechanism

Tipo di dati

boolean

Inhaler is cracked or broken apart
Descrizione

Inhaler is cracked or broken apart

Tipo di dati

boolean

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

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

Tipo di dati

boolean

Difficult to close mouthpiece cover
Descrizione

Difficult to close mouthpiece cover

Tipo di dati

boolean

Powder fell out prior to use
Descrizione

Powder fell out prior to use

Tipo di dati

boolean

No powder came out
Descrizione

No powder came out

Tipo di dati

boolean

Device squeaks in operation
Descrizione

Device squeaks in operation

Tipo di dati

boolean

Device rattles in operation
Descrizione

Device rattles in operation

Tipo di dati

boolean

Dose counter did not count
Descrizione

Dose counter did not count

Tipo di dati

boolean

Dose counter is ambiguous
Descrizione

Dose counter is ambiguous

Tipo di dati

boolean

Dose counter overcounted
Descrizione

Dose counter overcounted

Tipo di dati

boolean

Dose counter undercounted
Descrizione

Dose counter undercounted

Tipo di dati

boolean

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

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

Tipo di dati

boolean

Device smelt/bad odour when pack opened
Descrizione

Device smelt/bad odour when pack opened

Tipo di dati

boolean

Other, specify
Descrizione

Other, specify

Tipo di dati

text

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Similar models

IP Device Malfunction Data

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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