ID
30192
Beschrijving
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 Nasal Examination, Vital Signs, ECG and Laboratory (Visit 1).
Trefwoorden
Versies (1)
- 18-05-18 18-05-18 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
18 mei 2018
DOI
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Licentie
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
Nasal Examination, Vital Signs, ECG, Laboratory - Visit 1
- StudyEvent: ODM
Beschrijving
Nasal Examination
Alias
- UMLS CUI-1
- C0558826
Beschrijving
Patency of Left Nostril
Datatype
text
Alias
- UMLS CUI [1,1]
- C0429212
- UMLS CUI [1,2]
- C0205091
Beschrijving
Patency of Right Nostril
Datatype
text
Alias
- UMLS CUI [1,1]
- C0429212
- UMLS CUI [1,2]
- C0205090
Beschrijving
Septum
Datatype
text
Alias
- UMLS CUI [1]
- C0027432
Beschrijving
Septum Deviation
Datatype
integer
Alias
- UMLS CUI [1]
- C0549397
Beschrijving
Mucosal oedema left nostril
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0521481
- UMLS CUI [1,2]
- C0028429
- UMLS CUI [1,3]
- C0205091
Beschrijving
Mucosal oedema right nostril
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0521481
- UMLS CUI [1,2]
- C0028429
- UMLS CUI [1,3]
- C0205090
Beschrijving
Crusting of left nasal Mucosa
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205204
- UMLS CUI [1,2]
- C0027428
- UMLS CUI [1,3]
- C0205091
Beschrijving
Crusting of right nasal Mucosa
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205204
- UMLS CUI [1,2]
- C0027428
- UMLS CUI [1,3]
- C0205090
Beschrijving
Bleeding of Left Nasal Mucosa
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0014591
- UMLS CUI [1,2]
- C0205091
Beschrijving
Bleeding of right Nasal Mucosa
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0014591
- UMLS CUI [1,2]
- C0205090
Beschrijving
Secretion from left nostril
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1546724
- UMLS CUI [1,2]
- C0205091
Beschrijving
Color of Secretion from left nostril
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1880121
- UMLS CUI [1,2]
- C1546724
- UMLS CUI [1,3]
- C0205091
Beschrijving
Secretion from right Nostril
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1546724
- UMLS CUI [1,2]
- C0205090
Beschrijving
Color of Secretion from right Nostril
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1880121
- UMLS CUI [1,2]
- C1546724
- UMLS CUI [1,3]
- C0205090
Beschrijving
Ulcers on left turbinates
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1407910
- UMLS CUI [1,2]
- C0205091
Beschrijving
Ulcers on left nasal septum
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0264268
- UMLS CUI [1,2]
- C0205091
Beschrijving
Ulcers on right turbinates
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1407910
- UMLS CUI [1,2]
- C0205090
Beschrijving
Ulcers on right nasal septum
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0264268
- UMLS CUI [1,2]
- C0205090
Beschrijving
Size of the largest polyp, if present
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C2087484
- UMLS CUI [1,3]
- C0205091
Beschrijving
Size of the largest polyp, if present
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0027432
- UMLS CUI [1,3]
- C0205091
Beschrijving
Size of the largest polyp, if present
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C2087484
- UMLS CUI [1,3]
- C0205090
Beschrijving
Size of the largest polyp, if present
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0027432
- UMLS CUI [1,3]
- C0205090
Beschrijving
Nasal Candidiasis Examination
Alias
- UMLS CUI-1
- C2239140
- UMLS CUI-2
- C0006840
Beschrijving
Subjects with evidence of Candidiasis are not eligible for the study. f there is clinical evidence of nasal candidiasis: Ensure that a swab has been taken. Ensure that all medications used to treat the infection are recorded on the Concomitant Medications page. Ensure that nasal candidiasis when present is recorded on the Current Medical Conditions page.
Datatype
text
Alias
- UMLS CUI [1]
- C0919658
Beschrijving
Nasal Swab taken
Datatype
text
Alias
- UMLS CUI [1]
- C3669207
Beschrijving
Ensure that only one result of the swab has been recorded and is correct. If swab result will never be known ensure that ’Not Available’ is marked.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3669207
- UMLS CUI [1,2]
- C1274040
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Date of ECG
Datatype
date
Alias
- UMLS CUI [1]
- C2826640
Beschrijving
Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0040223
Beschrijving
If clinically significant abnormality, record medical condition in the (Past/current) Medical Conditions form.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C0430456
Beschrijving
Central Laboratory
Alias
- UMLS CUI-1
- C1880016
Similar models
Nasal Examination, Vital Signs, ECG, Laboratory - Visit 1
- StudyEvent: ODM
C0205091 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,2])
C0028429 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C0028429 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C0027428 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C0027428 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C0205091 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,2])
C1546724 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C0205090 (UMLS CUI [1,2])
C1546724 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C0205091 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,2])
C2087484 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C0027432 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C2087484 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C0027432 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C0006840 (UMLS CUI-2)
C1274040 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])