ID

30191

Description

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 Administrative Data (Visit 1).

Keywords

Versions (1)
  1. 5/18/18 5/18/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

May 18, 2018

DOI

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License

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

English

Administrative Data - Visit 1

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Pick the racial group which best describes the subject’s racial origin.
Description

The racial groups below are based on the subject’s genotypical racial origin, not nationality or where they currently reside. American Hispanic: With racial origin in Central or South America Arabic/North African: With racial origin in North Africa/Middle East Black: With racial origin in Central, East or West Africa East and South East Asian: With racial origin in East and South East Asia, e.g., Chinese, Korean, Thai, Vietnamese Japanese: With racial origin in Japan South Asian: With racial origin in South Asia e.g., Indian, Pakistani White/Caucasian: With racial origin in Europe Other: With racial origin not represented above or whose predominate origin can not be determined

Data type

text

Alias
UMLS CUI [1]
C0034510
Screen Failure
Description

Screen Failure

Alias
UMLS CUI-1
C1710476
Was this subject a screen failure?
Description

A subject who is assigned a subject number, but is not randomised has failed screening.

Data type

text

Alias
UMLS CUI [1]
C1710476
Screen Failure Date
Description

Screen Failure Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710476
If screen failure, what was the primary reason?
Description

If adverse event, record details in the Non-Serious Adverse Events or Serious Adverse Event forms as appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0392360
If other reason for screen failure, specify:
Description

Other Reason for Screen Failure

Data type

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0392360
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Similar models

Administrative Data - Visit 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Pick the racial group which best describes the subject’s racial origin.
text
C0034510 (UMLS CUI [1])
Race
Code List
Pick the racial group which best describes the subject’s racial origin.
CL Item
American Hispanic (1)
CL Item
Arabic/North African (2)
CL Item
Black (3)
CL Item
East and South East Asian (4)
CL Item
Japanese (5)
CL Item
South Asian (6)
CL Item
White/Caucasian (7)
CL Item
Other (Z)
Item Group
Screen Failure
C1710476 (UMLS CUI-1)
Item
Was this subject a screen failure?
text
C1710476 (UMLS CUI [1])
Screen failure
Code List
Was this subject a screen failure?
CL Item
Yes (Y)
CL Item
No (N)
Screen Failure Date
Item
Screen Failure Date
date
C0011008 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
Item
If screen failure, what was the primary reason?
text
C1710476 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for screen failure
Code List
If screen failure, 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 study (4)
CL Item
Did not fulfill eligibility criteria (6)
CL Item
Other (OT)
Other Reason for Screen Failure
Item
If other reason for screen failure, specify:
text
C1710476 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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