ID
30200
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 Nasal and Ophthalmic Examination, Vital Signs, ECG and Laboratory; Visit 8, Week 24, Day 169+/-2 days.
Mots-clés
Versions (1)
- 18/05/2018 18/05/2018 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
18 mai 2018
DOI
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Licence
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
Description
Nasal Examination
Alias
- UMLS CUI-1
- C0558826
Description
Patency of Left Nostril
Type de données
text
Alias
- UMLS CUI [1,1]
- C0429212
- UMLS CUI [1,2]
- C0205091
Description
Patency of Right Nostril
Type de données
text
Alias
- UMLS CUI [1,1]
- C0429212
- UMLS CUI [1,2]
- C0205090
Description
Septum
Type de données
text
Alias
- UMLS CUI [1]
- C0027432
Description
Septum Deviation
Type de données
integer
Alias
- UMLS CUI [1]
- C0549397
Description
Mucosal oedema left nostril
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0521481
- UMLS CUI [1,2]
- C0028429
- UMLS CUI [1,3]
- C0205091
Description
Mucosal oedema right nostril
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0521481
- UMLS CUI [1,2]
- C0028429
- UMLS CUI [1,3]
- C0205090
Description
Crusting of left nasal Mucosa
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0205204
- UMLS CUI [1,2]
- C0027428
- UMLS CUI [1,3]
- C0205091
Description
Crusting of right nasal Mucosa
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0205204
- UMLS CUI [1,2]
- C0027428
- UMLS CUI [1,3]
- C0205090
Description
Bleeding of Left Nasal Mucosa
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0014591
- UMLS CUI [1,2]
- C0205091
Description
Bleeding of right Nasal Mucosa
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0014591
- UMLS CUI [1,2]
- C0205090
Description
Secretion from left nostril
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1546724
- UMLS CUI [1,2]
- C0205091
Description
Color of Secretion from left nostril
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1880121
- UMLS CUI [1,2]
- C1546724
- UMLS CUI [1,3]
- C0205091
Description
Secretion from right Nostril
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1546724
- UMLS CUI [1,2]
- C0205090
Description
Color of Secretion from right Nostril
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1880121
- UMLS CUI [1,2]
- C1546724
- UMLS CUI [1,3]
- C0205090
Description
Ulcers on left turbinates
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1407910
- UMLS CUI [1,2]
- C0205091
Description
Ulcers on left nasal septum
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0264268
- UMLS CUI [1,2]
- C0205091
Description
Ulcers on right turbinates
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1407910
- UMLS CUI [1,2]
- C0205090
Description
Ulcers on right nasal septum
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0264268
- UMLS CUI [1,2]
- C0205090
Description
Size of the largest polyp, if present
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C2087484
- UMLS CUI [1,3]
- C0205091
Description
Size of the largest polyp, if present
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0027432
- UMLS CUI [1,3]
- C0205091
Description
Size of the largest polyp, if present
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C2087484
- UMLS CUI [1,3]
- C0205090
Description
Size of the largest polyp, if present
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0027430
- UMLS CUI [1,2]
- C0027432
- UMLS CUI [1,3]
- C0205090
Description
Nasal Candidiasis Examination
Alias
- UMLS CUI-1
- C2239140
- UMLS CUI-2
- C0006840
Description
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.
Type de données
text
Alias
- UMLS CUI [1]
- C0919658
Description
Nasal Swab taken
Type de données
text
Alias
- UMLS CUI [1]
- C3669207
Description
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.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3669207
- UMLS CUI [1,2]
- C1274040
Description
Ophthalmic Examination
Alias
- UMLS CUI-1
- C0200149
Description
Answer once
Type de données
date
Alias
- UMLS CUI [1,1]
- C0200149
- UMLS CUI [1,2]
- C0011008
Description
Answer once
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200149
Description
Answer once
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704292
- UMLS CUI [1,2]
- C2826892
- UMLS CUI [2,1]
- C1704292
- UMLS CUI [2,2]
- C0029146
Description
Answer each of the following items of this itemgroup for both sides
Type de données
text
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0200149
Description
Tonometry (Goldmann Applanation)
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0578862
Description
Macula
Type de données
integer
Alias
- UMLS CUI [1]
- C0423419
Description
Cup Disc
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0278233
Description
Pigment/Naevus
Type de données
integer
Alias
- UMLS CUI [1]
- C0423417
Description
Retinal Vessels
Type de données
integer
Alias
- UMLS CUI [1]
- C0035330
Description
Exudates
Type de données
integer
Alias
- UMLS CUI [1]
- C0240897
Description
Microaneurysms
Type de données
integer
Alias
- UMLS CUI [1]
- C0154834
Description
Retinal haemorrhage
Type de données
integer
Alias
- UMLS CUI [1]
- C0035317
Description
Cornea
Type de données
integer
Alias
- UMLS CUI [1]
- C0010031
Description
Epithelial Abnormality of Cornea
Type de données
text
Alias
- UMLS CUI [1,1]
- C1855670
- UMLS CUI [1,2]
- C0459875
Description
Stromal Abnormality of Cornea
Type de données
text
Alias
- UMLS CUI [1,1]
- C1855670
- UMLS CUI [1,2]
- C0010040
Description
Endothelial Abnormality of Cornea
Type de données
text
Alias
- UMLS CUI [1,1]
- C1855670
- UMLS CUI [1,2]
- C0014259
Description
Iris
Type de données
integer
Alias
- UMLS CUI [1]
- C0022077
Description
Pupil
Type de données
integer
Alias
- UMLS CUI [1]
- C0034121
Description
Cataract
Type de données
text
Alias
- UMLS CUI [1]
- C0086543
Description
Cataract type
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C0332307
Description
Extent of posterior subcapsular cataract
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0858617
- UMLS CUI [1,2]
- C0439792
Description
Conjunctival Cyst
Type de données
integer
Alias
- UMLS CUI [1]
- C0155170
Description
Pterygium
Type de données
integer
Alias
- UMLS CUI [1]
- C0033999
Description
Pinguecula
Type de données
integer
Alias
- UMLS CUI [1]
- C0152255
Description
Conjunctival Naevus
Type de données
integer
Alias
- UMLS CUI [1]
- C0346363
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
Date of ECG
Type de données
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Description
Time of ECG
Type de données
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0040223
Description
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.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Description
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.
Type de données
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])