ID
30200
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 and Ophthalmic Examination, Vital Signs, ECG and Laboratory; Visit 8, Week 24, Day 169+/-2 days.
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 and Opthalmic Examination, Vital Signs, ECG - Visit 8
- 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
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.
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; 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.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3669207
- UMLS CUI [1,2]
- C1274040
Beschrijving
Ophthalmic Examination
Alias
- UMLS CUI-1
- C0200149
Beschrijving
Answer once
Datatype
date
Alias
- UMLS CUI [1,1]
- C0200149
- UMLS CUI [1,2]
- C0011008
Beschrijving
Answer once
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200149
Beschrijving
Answer once
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704292
- UMLS CUI [1,2]
- C2826892
- UMLS CUI [2,1]
- C1704292
- UMLS CUI [2,2]
- C0029146
Beschrijving
Answer each of the following items of this itemgroup for both sides
Datatype
text
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0200149
Beschrijving
Tonometry (Goldmann Applanation)
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0578862
Beschrijving
Macula
Datatype
integer
Alias
- UMLS CUI [1]
- C0423419
Beschrijving
Cup Disc
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0278233
Beschrijving
Pigment/Naevus
Datatype
integer
Alias
- UMLS CUI [1]
- C0423417
Beschrijving
Retinal Vessels
Datatype
integer
Alias
- UMLS CUI [1]
- C0035330
Beschrijving
Exudates
Datatype
integer
Alias
- UMLS CUI [1]
- C0240897
Beschrijving
Microaneurysms
Datatype
integer
Alias
- UMLS CUI [1]
- C0154834
Beschrijving
Retinal haemorrhage
Datatype
integer
Alias
- UMLS CUI [1]
- C0035317
Beschrijving
Cornea
Datatype
integer
Alias
- UMLS CUI [1]
- C0010031
Beschrijving
Epithelial Abnormality of Cornea
Datatype
text
Alias
- UMLS CUI [1,1]
- C1855670
- UMLS CUI [1,2]
- C0459875
Beschrijving
Stromal Abnormality of Cornea
Datatype
text
Alias
- UMLS CUI [1,1]
- C1855670
- UMLS CUI [1,2]
- C0010040
Beschrijving
Endothelial Abnormality of Cornea
Datatype
text
Alias
- UMLS CUI [1,1]
- C1855670
- UMLS CUI [1,2]
- C0014259
Beschrijving
Iris
Datatype
integer
Alias
- UMLS CUI [1]
- C0022077
Beschrijving
Pupil
Datatype
integer
Alias
- UMLS CUI [1]
- C0034121
Beschrijving
Cataract
Datatype
text
Alias
- UMLS CUI [1]
- C0086543
Beschrijving
Cataract type
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C0332307
Beschrijving
Extent of posterior subcapsular cataract
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0858617
- UMLS CUI [1,2]
- C0439792
Beschrijving
Conjunctival Cyst
Datatype
integer
Alias
- UMLS CUI [1]
- C0155170
Beschrijving
Pterygium
Datatype
integer
Alias
- UMLS CUI [1]
- C0033999
Beschrijving
Pinguecula
Datatype
integer
Alias
- UMLS CUI [1]
- C0152255
Beschrijving
Conjunctival Naevus
Datatype
integer
Alias
- UMLS CUI [1]
- C0346363
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Date of ECG
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Beschrijving
Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0040223
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Beschrijving
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.
Datatype
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])