ID

33979

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 Electronically transferred laboratory data (Lab). It has to be filled in for screening, TP1-4 for each Day -1 and 7, follow-up and if required for Logs/Repeat.

Link

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

Stichworte

Versionen (1)
  1. 09.01.19 09.01.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. 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

Electronically transferred laboratory data (Lab)

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Treatment period and Day
Beschreibung

Treatment type/Treatment period and Day

Datentyp

text

Alias
UMLS CUI [1]
C0087111
Electronically transferred laboratory data (Lab) - Haematology
Beschreibung

Electronically transferred laboratory data (Lab) - Haematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
Sample taken
Beschreibung

If you tick 99 note date and time in following items.

Datentyp

text

Alias
UMLS CUI [1]
C1277698
Date sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Time sample taken
Beschreibung

00:00-23:59. Time is optional. Use this item as the first item on this form. For additional tests, use the second item.

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Electronically transferred laboratory data (Lab) - Clinical chemistry
Beschreibung

Electronically transferred laboratory data (Lab) - Clinical chemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Sample taken
Beschreibung

If you tick 99 note date and time in following items.

Datentyp

text

Alias
UMLS CUI [1]
C1277698
Date sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Time sample taken
Beschreibung

00:00-23:59. Time is optional. Use this Item for all other samples on the form

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Electronically transferred laboratory data (Lab) - Urinalysis
Beschreibung

Electronically transferred laboratory data (Lab) - Urinalysis

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0042014
Sample taken
Beschreibung

If you tick 99 note date and time in following items.

Datentyp

text

Alias
UMLS CUI [1]
C1277698
Date sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Time sample taken
Beschreibung

00:00-23:59. Time is optional. Use this Item as the first Item on this form. For additional tests, use the second Item.

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
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Ähnliche Modelle

Electronically transferred laboratory data (Lab)

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
Treatment period and Day
text
C0087111 (UMLS CUI [1])
Treatment type/Treatment period and Day
Code List
Treatment period and Day
CL Item
Screening (1)
CL Item
TP1D-1  (2)
CL Item
TP1D7 (3)
CL Item
TP2D-1 (4)
CL Item
TP2D7 (5)
CL Item
TP3D-1 (6)
CL Item
TP3D7 (7)
CL Item
TP4D-1 (8)
CL Item
TP4D7 (9)
CL Item
Follow-up (10)
CL Item
Logs/Repeat (11)
Item Group
Electronically transferred laboratory data (Lab) - Haematology
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Item
Sample taken
text
C1277698 (UMLS CUI [1])
Sample taken
Code List
Sample taken
CL Item
Not done (ND)
CL Item
Done (99)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Time sample taken
Item
Time sample taken
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data (Lab) - Clinical chemistry
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Item
Sample taken
text
C1277698 (UMLS CUI [1])
Sample taken
Code List
Sample taken
CL Item
Not done (ND)
CL Item
Done (99)
CL Item
Same as the Heamatology sample (98)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Time sample taken
Item
Time sample taken
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data (Lab) - Urinalysis
C0022885 (UMLS CUI-1)
C0042014 (UMLS CUI-2)
Item
Sample taken
text
C1277698 (UMLS CUI [1])
Sample taken
Code List
Sample taken
CL Item
Not done (ND)
CL Item
Done (99)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Time sample taken
Item
Time sample taken
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
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