ID

33703

Beschrijving

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, 8 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 study conclusion form and the pregnancy information. It has to be filled in for the end of study.

Link

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

Trefwoorden

Versies (2)
  1. 20-12-18 20-12-18 -
  2. 20-12-18 20-12-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

20 december 2018

DOI

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Licentie

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

Engels

Study conclusion, pregnancy information

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Study conclusion
Beschrijving

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of last contact
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Beschrijving

If yes complete the following items for withdrawing information

Datatype

text

Alias
UMLS CUI [1]
C0422727
Date of decision to withdraw
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Primary reason for withdrawal
Beschrijving

If you tick 1: Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. To 5: Select this reason if none of the other primary reasons are appropriate. 5, 7 and 8 are optional.

Datatype

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
If you tick in "reason for withdrawal" investigator discretion, please specify
Beschrijving

Investigator discretion

Datatype

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0022423
Case book ready for signature [hidden]
Beschrijving

Data owner should check the box when data cleaning is complete. Item Is not required

Datatype

text

Alias
UMLS CUI [1]
C1519316
Office Use 1 [hidden)
Beschrijving

Office Use 1

Datatype

text

Alias
UMLS CUI [1]
C0442603
Office Use 2 [hidden]
Beschrijving

Office Use 2

Datatype

integer

Alias
UMLS CUI [1,1]
C0442603
UMLS CUI [1,2]
C0237753
Pregnancy information
Beschrijving

Pregnancy information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beschrijving

For females. If Yes, complete the paper Pregnancy Notification form

Datatype

text

Alias
UMLS CUI [1]
C3828490
Did a female partner of the male subject become pregnant during the study?
Beschrijving

For males. If Yes, complete the paper Pregnancy Notification form. Check Not Applicable if female partner not of childbearing potential or no female partner.

Datatype

text

Alias
UMLS CUI [1]
C3828490
UMLS CUI [2,1]
C0919624
UMLS CUI [2,2]
C0086287
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Similar models

Study conclusion, pregnancy information

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Withdrawing
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes (Y)
Date of decision to withdraw
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Protocol deviation (2)
CL Item
Study closed/terminated (3)
CL Item
Lost to follow-up (4)
CL Item
investigator discretion (5)
CL Item
Withdrew consent (6)
CL Item
Lack of efficacy (7)
CL Item
Subject reached protocol-defined stopping criteria (8)
Investigator discretion
Item
If you tick in "reason for withdrawal" investigator discretion, please specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
Item
Case book ready for signature [hidden]
text
C1519316 (UMLS CUI [1])
Signature
Code List
Case book ready for signature [hidden]
CL Item
Yes (Y)
Item
Office Use 1 [hidden)
text
C0442603 (UMLS CUI [1])
Office Use 1
Code List
Office Use 1 [hidden)
CL Item
No (N)
CL Item
Yes (Y)
Item
Office Use 2 [hidden]
integer
C0442603 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Office Use 2
Code List
Office Use 2 [hidden]
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Pregnancy during study (Preg F)
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did a female partner of the male subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
C0919624 (UMLS CUI [2,1])
C0086287 (UMLS CUI [2,2])
Pregnancy during study (Preg M)
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (X)
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