ID

29544

Descrição

Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: IP Device Malfunction

Palavras-chave

Versões (2)
  1. 21/03/2018 21/03/2018 -
  2. 05/04/2018 05/04/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

5 de abril de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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GSK Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) NCT01009463

Inglês

IP Device Malfunction

1 Formulários  
  1. StudyEvent: ODM
    1. IP Device Malfunction
IP Device Malfunction
Descrição

IP Device Malfunction

Alias
UMLS CUI-1
C1881681
Investigational product container number
Descrição

Investigational product container number

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 device malfunction
Descrição

Device Malfunction reason

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1881681
UMLS CUI [1,2]
C0392360
Other Device Malfunction reason, specify
Descrição

Device Malfunction reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1881681
UMLS CUI [1,2]
C0392360
Voltar ao início da página

Similar models

IP Device Malfunction

1 Formulários
  1. StudyEvent: ODM
    1. IP Device Malfunction
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
IP Device Malfunction
C1881681 (UMLS CUI-1)
Investigational product container number
Item
Investigational product container number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Mark all applicable reasons for device malfunction
integer
C1881681 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Device Malfunction reason
Code List
Mark all applicable reasons for device malfunction
CL Item
Mouthpiece Cover does not stay at the fully actuated position (1)
CL Item
Mouthpiece cover came apart rrom the mechanism (2)
CL Item
Inhaler is cracked or broken apart (3)
CL Item
Difficult to open mouthpiece cover/force to actuate was too high (4)
CL Item
Difficult to close mouthpiece cover (5)
CL Item
Powder fell out prior to use (6)
CL Item
No powder came out (7)
CL Item
Device squeaks In operation (8)
CL Item
Device rattles in operation (9)
CL Item
Dose counter did not count (10)
CL Item
Dose counter is ambiguous (11)
CL Item
Dose counter overcounted (12)
CL Item
Dose counter undercounted (13)
CL Item
Difficult to pull air through the device as described in the leaflet (14)
CL Item
Device smelt/bad odour when pack opened (15)
CL Item
Other, specify (16)
Device Malfunction reason
Item
Other Device Malfunction reason, specify
text
C1881681 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Voltar ao início da página 

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