ID

34001

Beschreibung

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the Pharmacogenetic (PGx) research withdrawl of consent (PGx withdrawl) form. It has to be filled in for the end of study.

Link

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Stichworte

Versionen (3)
  1. 08.01.19 08.01.19 -
  2. 10.01.19 10.01.19 - Sarah Riepenhausen
  3. 10.01.19 10.01.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Januar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

Englisch

Pharmacogenetic (PGx) research withdrawl of consent (PGx withdrawl)

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Pharmacogenetic (PGx) research withdrawl of consent
Beschreibung

Pharmacogenetic (PGx) research withdrawl of consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C1707492
Has subject withdrawn consent for PGx research?
Beschreibung

Withdrawl of consent for PGx

Datentyp

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347500
If consent for PGx was withdrawn, please note the date of informed consent withdrawn
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
Has a request been made for sample destruction?
Beschreibung

Request to sample destruction

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If request to sample destruction was made, please check reasons
Beschreibung

Screen failure is an optional choice.

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
If other reason for request sample destruction, please specify
Beschreibung

Other reason for request to sample destruction

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
UMLS CUI [1,5]
C0205394
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Ähnliche Modelle

Pharmacogenetic (PGx) research withdrawl of consent (PGx withdrawl)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Pharmacogenetic (PGx) research withdrawl of consent
C2347500 (UMLS CUI-1)
C1707492 (UMLS CUI-2)
Item
Has subject withdrawn consent for PGx research?
text
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Withdrawl of consent for PGx
Code List
Has subject withdrawn consent for PGx research?
CL Item
Yes (Y)
CL Item
No (N)
Date of informed consent withdrawn
Item
If consent for PGx was withdrawn, please note the date of informed consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Has a request been made for sample destruction?
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Request to sample destruction
Code List
Has a request been made for sample destruction?
CL Item
Yes (Y)
CL Item
No (N)
Item
If request to sample destruction was made, please check reasons
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Request to sample destruction
Code List
If request to sample destruction was made, please check reasons
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other (Z)
Other reason for request to sample destruction
Item
If other reason for request sample destruction, please specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
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