ID

32504

Beschreibung

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

Stichworte

Versionen (2)
  1. 05.11.18 05.11.18 -
  2. 06.12.18 06.12.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

5. November 2018

DOI

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

Englisch

IP Device Malfunction Data

1 Formulare  
IP Device Malfunction
Beschreibung

IP Device Malfunction

Investigation Product Container Number
Beschreibung

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

Datentyp

text

Mark all applicable reasons for this device
Beschreibung

Mark all applicable reasons for this device

Mouthpiece cover does not stay at the fully actuated position
Beschreibung

Mouthpiece cover does not stay at the fully actuated position

Datentyp

boolean

Mouthpiece cover came apart from the mechanism
Beschreibung

Mouthpiece cover came apart from the mechanism

Datentyp

boolean

Inhaler is cracked or broken apart
Beschreibung

Inhaler is cracked or broken apart

Datentyp

boolean

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

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

Datentyp

boolean

Difficult to close mouthpiece cover
Beschreibung

Difficult to close mouthpiece cover

Datentyp

boolean

Powder fell out prior to use
Beschreibung

Powder fell out prior to use

Datentyp

boolean

No powder came out
Beschreibung

No powder came out

Datentyp

boolean

Device squeaks in operation
Beschreibung

Device squeaks in operation

Datentyp

boolean

Device rattles in operation
Beschreibung

Device rattles in operation

Datentyp

boolean

Dose counter did not count
Beschreibung

Dose counter did not count

Datentyp

boolean

Dose counter is ambiguous
Beschreibung

Dose counter is ambiguous

Datentyp

boolean

Dose counter overcounted
Beschreibung

Dose counter overcounted

Datentyp

boolean

Dose counter undercounted
Beschreibung

Dose counter undercounted

Datentyp

boolean

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

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

Datentyp

boolean

Device smelt/bad odour when pack opened
Beschreibung

Device smelt/bad odour when pack opened

Datentyp

boolean

Other, specify
Beschreibung

Other, specify

Datentyp

text

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Ähnliche Modelle

IP Device Malfunction Data

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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