ID

29933

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 Unscheduled / Emergency Clinic Contacts.

Keywords

Versions (1)
  1. 4/27/18 4/27/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 27, 2018

DOI

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License

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

English

Unscheduled / Emergency Clinic Contacts

1 forms  
Unscheduled / Emergency Clinic Contacts
Description

Unscheduled / Emergency Clinic Contacts

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

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 If the subject is withdrawn, complete Early Withdrawal pages and make an appointment for the subject to return for a follow-up visit in 1 week (± 2 days) time.

Data type

text

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

Date of unscheduled/emergency contact

Data type

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
Description

Type of Contact

Data type

text

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

e.g., headache

Data type

text

Alias
UMLS CUI [1]
C1547629
Subject withdrawn?
Description

Subject withdrawn

Data type

text

Alias
UMLS CUI [1]
C0422727
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Similar models

Unscheduled / Emergency Clinic Contacts

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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