ID

32504

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2018-11-05 2018-11-05 -
  2. 2018-12-06 2018-12-06 -
Rättsinnehavare

GSK group of companies

Uppladdad den

5 november 2018

DOI

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Licens

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

Engelsk

IP Device Malfunction Data

1 Formulär  
IP Device Malfunction
Beskrivning

IP Device Malfunction

Investigation Product Container Number
Beskrivning

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

Datatyp

text

Mark all applicable reasons for this device
Beskrivning

Mark all applicable reasons for this device

Mouthpiece cover does not stay at the fully actuated position
Beskrivning

Mouthpiece cover does not stay at the fully actuated position

Datatyp

boolean

Mouthpiece cover came apart from the mechanism
Beskrivning

Mouthpiece cover came apart from the mechanism

Datatyp

boolean

Inhaler is cracked or broken apart
Beskrivning

Inhaler is cracked or broken apart

Datatyp

boolean

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

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

Datatyp

boolean

Difficult to close mouthpiece cover
Beskrivning

Difficult to close mouthpiece cover

Datatyp

boolean

Powder fell out prior to use
Beskrivning

Powder fell out prior to use

Datatyp

boolean

No powder came out
Beskrivning

No powder came out

Datatyp

boolean

Device squeaks in operation
Beskrivning

Device squeaks in operation

Datatyp

boolean

Device rattles in operation
Beskrivning

Device rattles in operation

Datatyp

boolean

Dose counter did not count
Beskrivning

Dose counter did not count

Datatyp

boolean

Dose counter is ambiguous
Beskrivning

Dose counter is ambiguous

Datatyp

boolean

Dose counter overcounted
Beskrivning

Dose counter overcounted

Datatyp

boolean

Dose counter undercounted
Beskrivning

Dose counter undercounted

Datatyp

boolean

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

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

Datatyp

boolean

Device smelt/bad odour when pack opened
Beskrivning

Device smelt/bad odour when pack opened

Datatyp

boolean

Other, specify
Beskrivning

Other, specify

Datatyp

text

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Similar models

IP Device Malfunction Data

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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