ID

32557

Beschrijving

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

Trefwoorden

Versies (2)
  1. 06-11-18 06-11-18 -
  2. 06-12-18 06-12-18 -
Houder van rechten

GSK group of companies

Geüploaded op

6 november 2018

DOI

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Licentie

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

Engels

Study conclusion

1 Formulieren  
  1. StudyEvent: ODM
    1. Study conclusion
Study conclusion details
Beschrijving

Study conclusion details

Date of subject completion or withdrawal
Beschrijving

Date of subject completion or withdrawal

Datatype

date

Was the subject withdrawn from the study?
Beschrijving

Was the subject withdrawn from the study?

Datatype

boolean

If YES, complete primary reason for withdrawal
Beschrijving

If YES, complete primary reason for withdrawal

1. Adverse event
Beschrijving

record details on AE or SAE forms as appropriate)

Datatype

boolean

2. Lack of efficacy
Beschrijving

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

Datatype

text

3. Protocol Deviation
Beschrijving

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

Datatype

text

4. Subject reached protocol defined stopping criteria
Beschrijving

4. Subject reached protocol defined stopping criteria

Datatype

text

5. Study closed/terminated
Beschrijving

5. Study closed/terminated

Datatype

boolean

6. Lost to Follow-Up
Beschrijving

6. Lost to Follow-Up

Datatype

boolean

7. Investigator discretion, specify
Beschrijving

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

Datatype

text

8. Withdrew consent, specify
Beschrijving

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

Datatype

text

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Similar models

Study conclusion

1 Formulieren
  1. StudyEvent: ODM
    1. Study conclusion
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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