ID

29931

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 Repeat 12-lead-ECG.

Trefwoorden

Versies (1)
  1. 27-04-18 27-04-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

27 april 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

Engels

Repeat 12-lead-ECG

1 Formulieren  
  1. StudyEvent: ODM
    1. Repeat 12-lead-ECG
12-Lead ECG Repeat
Beschrijving

12-Lead ECG Repeat

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0205341
Date of ECG
Beschrijving

Date of ECG

Datatype

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0011008
Time of ECG
Beschrijving

Time of ECG

Datatype

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0040223
Result of ECG
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. If the original ECG at Visit 1 is classified as ’abnormal, clinically significant’, the subject should not be randomised - even if a repeat ECG is ’normal’ or ’abnormal, clinically insignificant’." 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]
C0205341
UMLS CUI [1,3]
C1274040
Change in ECG result
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
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Similar models

Repeat 12-lead-ECG

1 Formulieren
  1. StudyEvent: ODM
    1. Repeat 12-lead-ECG
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
12-Lead ECG Repeat
C0430456 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Date of ECG
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Result of ECG
integer
C0430456 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
ECG Results
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
Item
Change in ECG result
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
Change in ECG result
Code List
Change in ECG result
CL Item
Clinically significant change from baseline - favourable (1)
CL Item
Clinically significant change from baseline - unfavourable (2)
CL Item
No change or insignificant change from baseline (3)
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