ID
30192
Beschreibung
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).
Stichworte
Versionen (1)
- 18.05.18 18.05.18 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
18. Mai 2018
DOI
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Lizenz
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
Beschreibung
Nasal Examination
Alias
- UMLS CUI-1
- C0558826
Beschreibung
Patency of Left Nostril
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0429212
- UMLS CUI [1,2]
- C0205091
Beschreibung
Patency of Right Nostril
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0429212
- UMLS CUI [1,2]
- C0205090
Beschreibung
Septum
Datentyp
text
Alias
- UMLS CUI [1]
- C0027432
Beschreibung
Septum Deviation
Datentyp
integer
Alias
- UMLS CUI [1]
- C0549397
Beschreibung
Mucosal oedema left nostril
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0521481
- UMLS CUI [1,2]
- C0028429
- UMLS CUI [1,3]
- C0205091
Beschreibung
Mucosal oedema right nostril
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0521481
- UMLS CUI [1,2]
- C0028429
- UMLS CUI [1,3]
- C0205090
Beschreibung
Crusting of left nasal Mucosa
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205204
- UMLS CUI [1,2]
- C0027428
- UMLS CUI [1,3]
- C0205091
Beschreibung
Crusting of right nasal Mucosa
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205204
- UMLS CUI [1,2]
- C0027428
- UMLS CUI [1,3]
- C0205090
Beschreibung
Bleeding of Left Nasal Mucosa
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0014591
- UMLS CUI [1,2]
- C0205091
Beschreibung
Bleeding of right Nasal Mucosa
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0014591
- UMLS CUI [1,2]
- C0205090
Beschreibung
Secretion from left nostril
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1546724
- UMLS CUI [1,2]
- C0205091
Beschreibung
Color of Secretion from left nostril
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1880121
- UMLS CUI [1,2]
- C1546724
- UMLS CUI [1,3]
- C0205091
Beschreibung
Secretion from right Nostril
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1546724
- UMLS CUI [1,2]
- C0205090
Beschreibung
Color of Secretion from right Nostril
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1880121
- UMLS CUI [1,2]
- C1546724
- UMLS CUI [1,3]
- C0205090
Beschreibung
Ulcers on left turbinates
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1407910
- UMLS CUI [1,2]
- C0205091
Beschreibung
Ulcers on left nasal septum
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0264268
- UMLS CUI [1,2]
- C0205091
Beschreibung
Ulcers on right turbinates
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1407910
- UMLS CUI [1,2]
- C0205090
Beschreibung
Ulcers on right nasal septum
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0264268
- UMLS CUI [1,2]
- C0205090
Beschreibung
Size of the largest polyp, if present
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C2087484
- UMLS CUI [1,3]
- C0205091
Beschreibung
Size of the largest polyp, if present
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0027432
- UMLS CUI [1,3]
- C0205091
Beschreibung
Size of the largest polyp, if present
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C2087484
- UMLS CUI [1,3]
- C0205090
Beschreibung
Size of the largest polyp, if present
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0027432
- UMLS CUI [1,3]
- C0205090
Beschreibung
Nasal Candidiasis Examination
Alias
- UMLS CUI-1
- C2239140
- UMLS CUI-2
- C0006840
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C0919658
Beschreibung
Nasal Swab taken
Datentyp
text
Alias
- UMLS CUI [1]
- C3669207
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3669207
- UMLS CUI [1,2]
- C1274040
Beschreibung
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Date of ECG
Datentyp
date
Alias
- UMLS CUI [1]
- C2826640
Beschreibung
Time of ECG
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0040223
Beschreibung
If clinically significant abnormality, record medical condition in the (Past/current) Medical Conditions form.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C0430456
Beschreibung
Central Laboratory
Alias
- UMLS CUI-1
- C1880016
Ähnliche Modelle
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])