ID

29927

Descrição

Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Study Conclusion.

Palavras-chave

Versões (1)
  1. 27/04/2018 27/04/2018 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

27 de abril de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123

Inglês

Study Conclusion

1 Formulários  
  1. StudyEvent: ODM
    1. Study Conclusion
Study Conclusion
Descrição

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion of withdrawal
Descrição

If subject completed study the date must match the last scheduled study visit date. If subject withdrew and a withdrawal visit was conducted the date must match the date of subject withdrawal. If subject lost to follow-up the date must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.

Tipo de dados

date

Alias
UMLS CUI [1]
C2983670
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0422727
Was the subject withdrawn from study?
Descrição

Subject withdrawn from study

Tipo de dados

text

Alias
UMLS CUI [1]
C0422727
If the subject was withdrawn from trial, what was the primary reason?
Descrição

If Adverse Event was the reason, record details on the Non-Serious or Serious Adverse Events pages as appropriate.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
If other primary reason for withdrawal, specify
Descrição

Other Primary reason for withdrawal

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Pregnancy Information
Descrição

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Descrição

If Yes, complete Pregnancy Notification form.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Investigator's Signature
Descrição

Investigator's Signature

Alias
UMLS CUI-1
C2346576
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Descrição

The Investigator is accountable for CRF data. However, the Principal Investigator may delegate CRF signature authority to a medically qualified Sub-investigator (as indicated on the Site Staff Signature Sheet).

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Date of Investigator's signature
Descrição

Date of Investigator's signature

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's Name (print)
Descrição

Investigator's Name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Study Conclusion

1 Formulários
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion of withdrawal
Item
Date of subject completion of withdrawal
date
C2983670 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
Item
Was the subject withdrawn from study?
text
C0422727 (UMLS CUI [1])
Subject withdrawn from study
Code List
Was the subject withdrawn from study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If the subject was withdrawn from trial, what was the primary reason?
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
If the subject was withdrawn from trial, what was the primary reason?
CL Item
Adverse Event (1)
CL Item
Lost to Follow-up (2)
CL Item
Protocol Violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
CL Item
Other (Z)
Item
If other primary reason for withdrawal, specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
If other primary reason for withdrawal, specify
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Pregnancy during trial
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (not of childbearing potential or male) (X)
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
text
C2346576 (UMLS CUI [1])
Date of Investigator's signature
Item
Date of Investigator's signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's Name
Item
Investigator's Name (print)
text
C2826892 (UMLS CUI [1])
Voltar ao início da página 

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