ID
30200
Descripción
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 and Ophthalmic Examination, Vital Signs, ECG and Laboratory; Visit 8, Week 24, Day 169+/-2 days.
Palabras clave
Versiones (1)
- 18/5/18 18/5/18 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
18 de mayo de 2018
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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 and Opthalmic Examination, Vital Signs, ECG - Visit 8
- StudyEvent: ODM
Descripción
Nasal Examination
Alias
- UMLS CUI-1
- C0558826
Descripción
Patency of Left Nostril
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0429212
- UMLS CUI [1,2]
- C0205091
Descripción
Patency of Right Nostril
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0429212
- UMLS CUI [1,2]
- C0205090
Descripción
Septum
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0027432
Descripción
Septum Deviation
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0549397
Descripción
Mucosal oedema left nostril
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0521481
- UMLS CUI [1,2]
- C0028429
- UMLS CUI [1,3]
- C0205091
Descripción
Mucosal oedema right nostril
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0521481
- UMLS CUI [1,2]
- C0028429
- UMLS CUI [1,3]
- C0205090
Descripción
Crusting of left nasal Mucosa
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0205204
- UMLS CUI [1,2]
- C0027428
- UMLS CUI [1,3]
- C0205091
Descripción
Crusting of right nasal Mucosa
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0205204
- UMLS CUI [1,2]
- C0027428
- UMLS CUI [1,3]
- C0205090
Descripción
Bleeding of Left Nasal Mucosa
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0014591
- UMLS CUI [1,2]
- C0205091
Descripción
Bleeding of right Nasal Mucosa
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0014591
- UMLS CUI [1,2]
- C0205090
Descripción
Secretion from left nostril
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1546724
- UMLS CUI [1,2]
- C0205091
Descripción
Color of Secretion from left nostril
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1880121
- UMLS CUI [1,2]
- C1546724
- UMLS CUI [1,3]
- C0205091
Descripción
Secretion from right Nostril
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1546724
- UMLS CUI [1,2]
- C0205090
Descripción
Color of Secretion from right Nostril
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1880121
- UMLS CUI [1,2]
- C1546724
- UMLS CUI [1,3]
- C0205090
Descripción
Ulcers on left turbinates
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1407910
- UMLS CUI [1,2]
- C0205091
Descripción
Ulcers on left nasal septum
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0264268
- UMLS CUI [1,2]
- C0205091
Descripción
Ulcers on right turbinates
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1407910
- UMLS CUI [1,2]
- C0205090
Descripción
Ulcers on right nasal septum
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0264268
- UMLS CUI [1,2]
- C0205090
Descripción
Size of the largest polyp, if present
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C2087484
- UMLS CUI [1,3]
- C0205091
Descripción
Size of the largest polyp, if present
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0027432
- UMLS CUI [1,3]
- C0205091
Descripción
Size of the largest polyp, if present
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C2087484
- UMLS CUI [1,3]
- C0205090
Descripción
Size of the largest polyp, if present
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0027432
- UMLS CUI [1,3]
- C0205090
Descripción
Nasal Candidiasis Examination
Alias
- UMLS CUI-1
- C2239140
- UMLS CUI-2
- C0006840
Descripción
If 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 Non-Serious Adverse Events or Serious Adverse Events page(s) if applicable.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0919658
Descripción
Nasal Swab taken
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3669207
Descripción
Ensure that only one result of the swab has been recorded and is correct; results of previous swabs have to be recorded at the appropriate visit. If swab result will never be known ensure that ’Not Available’ is marked.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3669207
- UMLS CUI [1,2]
- C1274040
Descripción
Ophthalmic Examination
Alias
- UMLS CUI-1
- C0200149
Descripción
Answer once
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0200149
- UMLS CUI [1,2]
- C0011008
Descripción
Answer once
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200149
Descripción
Answer once
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1704292
- UMLS CUI [1,2]
- C2826892
- UMLS CUI [2,1]
- C1704292
- UMLS CUI [2,2]
- C0029146
Descripción
Answer each of the following items of this itemgroup for both sides
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0200149
Descripción
Tonometry (Goldmann Applanation)
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0578862
Descripción
Macula
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0423419
Descripción
Cup Disc
Tipo de datos
integer
Unidades de medida
- %
Alias
- UMLS CUI [1]
- C0278233
Descripción
Pigment/Naevus
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0423417
Descripción
Retinal Vessels
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0035330
Descripción
Exudates
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0240897
Descripción
Microaneurysms
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0154834
Descripción
Retinal haemorrhage
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0035317
Descripción
Cornea
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0010031
Descripción
Epithelial Abnormality of Cornea
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1855670
- UMLS CUI [1,2]
- C0459875
Descripción
Stromal Abnormality of Cornea
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1855670
- UMLS CUI [1,2]
- C0010040
Descripción
Endothelial Abnormality of Cornea
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1855670
- UMLS CUI [1,2]
- C0014259
Descripción
Iris
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0022077
Descripción
Pupil
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0034121
Descripción
Cataract
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0086543
Descripción
Cataract type
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C0332307
Descripción
Extent of posterior subcapsular cataract
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0858617
- UMLS CUI [1,2]
- C0439792
Descripción
Conjunctival Cyst
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0155170
Descripción
Pterygium
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0033999
Descripción
Pinguecula
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0152255
Descripción
Conjunctival Naevus
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0346363
Descripción
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Descripción
Date of ECG
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Descripción
Time of ECG
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0040223
Descripción
ECG must be repeated should any clinically significant abnormality/worsening be noted by the investigator post-randomisation or the ECG is flagged as unreadable by the central independent cardiologist. Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Descripción
Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0392747
Similar models
Nasal and Opthalmic Examination, Vital Signs, ECG - Visit 8
- 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])
C0011008 (UMLS CUI [1,2])
C0200149 (UMLS CUI [1,2])
C2826892 (UMLS CUI [1,2])
C1704292 (UMLS CUI [2,1])
C0029146 (UMLS CUI [2,2])
C0459875 (UMLS CUI [1,2])
C0010040 (UMLS CUI [1,2])
C0014259 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0439792 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])