ID

29929

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 Repeat Ophthalmic Examination.

Keywords

Versions (1)
  1. 4/27/18 4/27/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 27, 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

Repeat Opthalmic Examination

1 forms  
Repeat Ophthalmic Examination
Description

Repeat Ophthalmic Examination

Alias
UMLS CUI-1
C0200149
UMLS CUI-2
C0205341
Date of Repeat Ophthalmic Examination
Description

Date of Repeat Ophthalmic Examination

Data type

date

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0011008
Time of Repeat Opthalmic Examination
Description

Time of Repeat Opthalmic Examination

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0200149
Name of Ophthalmologist/Optometrist performing the examination
Description

Name of Ophthalmologist/Optometrist

Data type

text

Alias
UMLS CUI [1,1]
C1704292
UMLS CUI [1,2]
C2826892
UMLS CUI [2,1]
C1704292
UMLS CUI [2,2]
C0029146
Examined Side
Description

Answer each of the following items of this itemgroup for both sides

Data type

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0200149
Intraocular Pressure
Description

Tonometry (Goldmann Applanation)

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0578862
mmHg
Macula
Description

Macula

Data type

integer

Alias
UMLS CUI [1]
C0423419
Cup Disc
Description

Cup Disc

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0278233
%
Pigment/Naevus
Description

Pigment/Naevus

Data type

integer

Alias
UMLS CUI [1]
C0423417
Retinal Vessels
Description

Retinal Vessels

Data type

integer

Alias
UMLS CUI [1]
C0035330
Exudates
Description

Exudates

Data type

integer

Alias
UMLS CUI [1]
C0240897
Microaneurysms
Description

Microaneurysms

Data type

integer

Alias
UMLS CUI [1]
C0154834
Retinal haemorrhage
Description

Retinal haemorrhage

Data type

integer

Alias
UMLS CUI [1]
C0035317
Cornea
Description

Cornea

Data type

integer

Alias
UMLS CUI [1]
C0010031
If abnormal cornea, indicate if epithelial location.
Description

Epithelial Abnormality of Cornea

Data type

text

Alias
UMLS CUI [1,1]
C1855670
UMLS CUI [1,2]
C0459875
If abnormal cornea, indicate if stromal location.
Description

Stromal Abnormality of Cornea

Data type

text

Alias
UMLS CUI [1,1]
C1855670
UMLS CUI [1,2]
C0010040
If abnormal cornea, indicate if endothelial location.
Description

Endothelial Abnormality of Cornea

Data type

text

Alias
UMLS CUI [1,1]
C1855670
UMLS CUI [1,2]
C0014259
Iris
Description

Iris

Data type

integer

Alias
UMLS CUI [1]
C0022077
Pupil
Description

Pupil

Data type

integer

Alias
UMLS CUI [1]
C0034121
Cataract
Description

Cataract

Data type

text

Alias
UMLS CUI [1]
C0086543
If there is a cataract present, indicate the type
Description

Cataract type

Data type

integer

Alias
UMLS CUI [1,1]
C0086543
UMLS CUI [1,2]
C0332307
If posterior subcapsular cataract, how extensive?
Description

Extent of posterior subcapsular cataract

Data type

integer

Alias
UMLS CUI [1,1]
C0858617
UMLS CUI [1,2]
C0439792
Conjunctival Cyst
Description

Conjunctival Cyst

Data type

integer

Alias
UMLS CUI [1]
C0155170
Pterygium
Description

Pterygium

Data type

integer

Alias
UMLS CUI [1]
C0033999
Pinguecula
Description

Pinguecula

Data type

integer

Alias
UMLS CUI [1]
C0152255
Conjunctival Naevus
Description

Conjunctival Naevus

Data type

integer

Alias
UMLS CUI [1]
C0346363
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Similar models

Repeat Opthalmic Examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Repeat Ophthalmic Examination
C0200149 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Date of Repeat Ophthalmic Examination
Item
Date of Repeat Ophthalmic Examination
date
C0200149 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Repeat Opthalmic Examination
Item
Time of Repeat Opthalmic Examination
time
C0040223 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0200149 (UMLS CUI [1,3])
Name of Ophthalmologist/Optometrist
Item
Name of Ophthalmologist/Optometrist performing the examination
text
C1704292 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
C1704292 (UMLS CUI [2,1])
C0029146 (UMLS CUI [2,2])
Item
Examined Side
text
C0441987 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
Examined Side
Code List
Examined Side
CL Item
Left Eye (OS)
CL Item
Right Eye (OD)
Intraocular Pressure
Item
Intraocular Pressure
integer
C0578862 (UMLS CUI [1])
Item
Macula
integer
C0423419 (UMLS CUI [1])
Macula
Code List
Macula
CL Item
Normal (1)
CL Item
Abnormal (2)
Cup Disc
Item
Cup Disc
integer
C0278233 (UMLS CUI [1])
Item
Pigment/Naevus
integer
C0423417 (UMLS CUI [1])
Pigment/Naevus
Code List
Pigment/Naevus
CL Item
absent (0)
CL Item
present (1)
Item
Retinal Vessels
integer
C0035330 (UMLS CUI [1])
Macula
Code List
Retinal Vessels
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Exudates
integer
C0240897 (UMLS CUI [1])
Mucosal oedema left nostril
Code List
Exudates
CL Item
absent (0)
CL Item
present (1)
Item
Microaneurysms
integer
C0154834 (UMLS CUI [1])
Mucosal oedema left nostril
Code List
Microaneurysms
CL Item
absent (0)
CL Item
present (1)
Item
Retinal haemorrhage
integer
C0035317 (UMLS CUI [1])
Mucosal oedema left nostril
Code List
Retinal haemorrhage
CL Item
absent (0)
CL Item
present (1)
Item
Cornea
integer
C0010031 (UMLS CUI [1])
Macula
Code List
Cornea
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
If abnormal cornea, indicate if epithelial location.
text
C1855670 (UMLS CUI [1,1])
C0459875 (UMLS CUI [1,2])
Patency of Left Nostril
Code List
If abnormal cornea, indicate if epithelial location.
CL Item
Yes (Y)
CL Item
No (N)
Item
If abnormal cornea, indicate if stromal location.
text
C1855670 (UMLS CUI [1,1])
C0010040 (UMLS CUI [1,2])
Patency of Left Nostril
Code List
If abnormal cornea, indicate if stromal location.
CL Item
Yes (Y)
CL Item
No (N)
Item
If abnormal cornea, indicate if endothelial location.
text
C1855670 (UMLS CUI [1,1])
C0014259 (UMLS CUI [1,2])
Patency of Left Nostril
Code List
If abnormal cornea, indicate if endothelial location.
CL Item
Yes (Y)
CL Item
No (N)
Item
Iris
integer
C0022077 (UMLS CUI [1])
Macula
Code List
Iris
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Pupil
integer
C0034121 (UMLS CUI [1])
Macula
Code List
Pupil
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Cataract
text
C0086543 (UMLS CUI [1])
Patency of Left Nostril
Code List
Cataract
CL Item
Yes (Y)
CL Item
No (N)
Item
If there is a cataract present, indicate the type
integer
C0086543 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Cataract type
Code List
If there is a cataract present, indicate the type
CL Item
Cortical (1)
CL Item
Nuclear Sclerotic (2)
CL Item
Posterior subcapsular (3)
Item
If posterior subcapsular cataract, how extensive?
integer
C0858617 (UMLS CUI [1,1])
C0439792 (UMLS CUI [1,2])
Extent of posterior subcapsular cataract
Code List
If posterior subcapsular cataract, how extensive?
CL Item
Trace (1)
CL Item
Definite plaque (under 2 mm) (2)
CL Item
Definite plaque (2 mm or more) (3)
Item
Conjunctival Cyst
integer
C0155170 (UMLS CUI [1])
Pigment/Naevus
Code List
Conjunctival Cyst
CL Item
absent (0)
CL Item
present (1)
Item
Pterygium
integer
C0033999 (UMLS CUI [1])
Mucosal oedema left nostril
Code List
Pterygium
CL Item
absent (0)
CL Item
present (1)
Item
Pinguecula
integer
C0152255 (UMLS CUI [1])
Mucosal oedema left nostril
Code List
Pinguecula
CL Item
absent (0)
CL Item
present (1)
Item
Conjunctival Naevus
integer
C0346363 (UMLS CUI [1])
Mucosal oedema left nostril
Code List
Conjunctival Naevus
CL Item
absent (0)
CL Item
present (1)
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