ID
30211
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 and Ophthalmic Examination, Vital Signs, ECG; Visit 15, Week 52, Day 365+/-2 days.
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 and Opthalmic Examination, Vital Signs, ECG - Visit 15
- 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
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.
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; 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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3669207
- UMLS CUI [1,2]
- C1274040
Beschreibung
Ophthalmic Examination
Alias
- UMLS CUI-1
- C0200149
Beschreibung
Answer once
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0200149
- UMLS CUI [1,2]
- C0011008
Beschreibung
Answer once
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200149
Beschreibung
Answer once
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704292
- UMLS CUI [1,2]
- C2826892
- UMLS CUI [2,1]
- C1704292
- UMLS CUI [2,2]
- C0029146
Beschreibung
Answer each of the following items of this itemgroup for both sides
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0200149
Beschreibung
Tonometry (Goldmann Applanation)
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0578862
Beschreibung
Macula
Datentyp
integer
Alias
- UMLS CUI [1]
- C0423419
Beschreibung
Cup Disc
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0278233
Beschreibung
Pigment/Naevus
Datentyp
integer
Alias
- UMLS CUI [1]
- C0423417
Beschreibung
Retinal Vessels
Datentyp
integer
Alias
- UMLS CUI [1]
- C0035330
Beschreibung
Exudates
Datentyp
integer
Alias
- UMLS CUI [1]
- C0240897
Beschreibung
Microaneurysms
Datentyp
integer
Alias
- UMLS CUI [1]
- C0154834
Beschreibung
Retinal haemorrhage
Datentyp
integer
Alias
- UMLS CUI [1]
- C0035317
Beschreibung
Cornea
Datentyp
integer
Alias
- UMLS CUI [1]
- C0010031
Beschreibung
Epithelial Abnormality of Cornea
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1855670
- UMLS CUI [1,2]
- C0459875
Beschreibung
Stromal Abnormality of Cornea
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1855670
- UMLS CUI [1,2]
- C0010040
Beschreibung
Endothelial Abnormality of Cornea
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1855670
- UMLS CUI [1,2]
- C0014259
Beschreibung
Iris
Datentyp
integer
Alias
- UMLS CUI [1]
- C0022077
Beschreibung
Pupil
Datentyp
integer
Alias
- UMLS CUI [1]
- C0034121
Beschreibung
Cataract
Datentyp
text
Alias
- UMLS CUI [1]
- C0086543
Beschreibung
Cataract type
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C0332307
Beschreibung
Extent of posterior subcapsular cataract
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0858617
- UMLS CUI [1,2]
- C0439792
Beschreibung
Conjunctival Cyst
Datentyp
integer
Alias
- UMLS CUI [1]
- C0155170
Beschreibung
Pterygium
Datentyp
integer
Alias
- UMLS CUI [1]
- C0033999
Beschreibung
Pinguecula
Datentyp
integer
Alias
- UMLS CUI [1]
- C0152255
Beschreibung
Conjunctival Naevus
Datentyp
integer
Alias
- UMLS CUI [1]
- C0346363
Beschreibung
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Date of ECG
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Beschreibung
Time of ECG
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0040223
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0392747
Ähnliche Modelle
Nasal and Opthalmic Examination, Vital Signs, ECG - Visit 15
- 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])