ID

29933

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 Unscheduled / Emergency Clinic Contacts.

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

Unscheduled / Emergency Clinic Contacts

1 Formulieren  
Unscheduled / Emergency Clinic Contacts
Beschrijving

Unscheduled / Emergency Clinic Contacts

Alias
UMLS CUI-1
C1552423
Did the subject make any unscheduled emergency contact with the clinic during the study?
Beschrijving

The other items of this form/itemgroup should be completed each time the subject makes an unscheduled / emergency visit or telephone contact to the clinic (this question answered with YES). Ensure that any adverse events and/or changes in concomitant medications are also documented on the appropriate pages of the CRF. If the subject is withdrawn, complete Early Withdrawal pages and make an appointment for the subject to return for a follow-up visit in 1 week (± 2 days) time.

Datatype

text

Alias
UMLS CUI [1,1]
C1552423
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C0681850
Date of unscheduled/emergency contact
Beschrijving

Date of unscheduled/emergency contact

Datatype

date

Alias
UMLS CUI [1,1]
C1552423
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C0681850
UMLS CUI [1,4]
C0011008
Type of Contact
Beschrijving

Type of Contact

Datatype

text

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0332307
Reason for Contact
Beschrijving

e.g., headache

Datatype

text

Alias
UMLS CUI [1]
C1547629
Subject withdrawn?
Beschrijving

Subject withdrawn

Datatype

text

Alias
UMLS CUI [1]
C0422727
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Similar models

Unscheduled / Emergency Clinic Contacts

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Unscheduled / Emergency Clinic Contacts
C1552423 (UMLS CUI-1)
Item
Did the subject make any unscheduled emergency contact with the clinic during the study?
text
C1552423 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
unscheduled / emergency clinic contact
Code List
Did the subject make any unscheduled emergency contact with the clinic during the study?
CL Item
yes (Y)
CL Item
no (N)
Date of unscheduled/emergency contact
Item
Date of unscheduled/emergency contact
date
C1552423 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Type of Contact
text
C0332158 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Contact
Code List
Type of Contact
CL Item
Visit (V)
CL Item
Telephone (T)
Reason for Contact
Item
Reason for Contact
text
C1547629 (UMLS CUI [1])
Item
Subject withdrawn?
text
C0422727 (UMLS CUI [1])
unscheduled / emergency clinic contact
Code List
Subject withdrawn?
CL Item
yes (Y)
CL Item
no (N)
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