ID

32557

Description

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

Mots-clés

Versions (2)
  1. 06/11/2018 06/11/2018 -
  2. 06/12/2018 06/12/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

6 novembre 2018

DOI

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Licence

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

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Study conclusion

1 Formulaires  
  1. StudyEvent: ODM
    1. Study conclusion
Study conclusion details
Description

Study conclusion details

Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Type de données

date

Was the subject withdrawn from the study?
Description

Was the subject withdrawn from the study?

Type de données

boolean

If YES, complete primary reason for withdrawal
Description

If YES, complete primary reason for withdrawal

1. Adverse event
Description

record details on AE or SAE forms as appropriate)

Type de données

boolean

2. Lack of efficacy
Description

Check all that apply. If none, select "No Subreasons"

Type de données

text

3. Protocol Deviation
Description

Check all that apply. If none, select "No Subreasons"

Type de données

text

4. Subject reached protocol defined stopping criteria
Description

4. Subject reached protocol defined stopping criteria

Type de données

text

5. Study closed/terminated
Description

5. Study closed/terminated

Type de données

boolean

6. Lost to Follow-Up
Description

6. Lost to Follow-Up

Type de données

boolean

7. Investigator discretion, specify
Description

Select this reason if none of the other primary reasons are appropriate

Type de données

text

8. Withdrew consent, specify
Description

Select this reason if none of the other primary reasons are appropriate

Type de données

text

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Similar models

Study conclusion

1 Formulaires
  1. StudyEvent: ODM
    1. Study conclusion
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Study conclusion details
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
Item Group
If YES, complete primary reason for withdrawal
1. Adverse event
Item
1. Adverse event
boolean
Item
2. Lack of efficacy
text
2. Lack of efficacy
Code List
2. Lack of efficacy
CL Item
No subreasons (1)
CL Item
Exacerbation (2)
Item
3. Protocol Deviation
text
3. Protocol Deviation
Code List
3. Protocol Deviation
CL Item
No subreasons (1)
CL Item
Pregnancy (2)
CL Item
Lack of adherence (3)
CL Item
Prohibited medication use (4)
Item
4. Subject reached protocol defined stopping criteria
text
Subject reached protocol defined stopping criteria
Code List
4. Subject reached protocol defined stopping criteria
CL Item
Yes (1)
CL Item
No (2)
CL Item
Liver function test abnormality (3)
5. Study closed/terminated
Item
5. Study closed/terminated
boolean
6. Lost to Follow-Up
Item
6. Lost to Follow-Up
boolean
7. Investigator discretion, specify
Item
7. Investigator discretion, specify
text
8. Withdrew consent, specify
Item
8. Withdrew consent, specify
text
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