ID

34941

Beschreibung

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the Serum pregnancy test form. It has to be filled in for screening and for follow-up. It also contains the child-bearing potential form. It only has to be filled in for screening.

Stichworte

Versionen (1)
  1. 04.02.19 04.02.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. Februar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

Englisch

Serum pregnancy test, child-bearing potential

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject identifier
Beschreibung

Subject identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Visit Type
Beschreibung

Visit Type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332307 (Type - attribute)
SNOMED
261664005
UMLS CUI [1,2]
C0545082 (Visit)
Serum pregnancy test
Beschreibung

Serum pregnancy test

Alias
UMLS CUI-1
C0430060 (Serum pregnancy test (B-HCG))
SNOMED
166434005
Date of test
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008 (Date in time)
SNOMED
410671006
UMLS CUI [1,2]
C0430060 (Serum pregnancy test (B-HCG))
SNOMED
166434005
Test result
Beschreibung

Test result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430060 (Serum pregnancy test (B-HCG))
SNOMED
166434005
UMLS CUI [1,2]
C1274040 (Result)
SNOMED
394617004
Child-bearing potential (Complete for Female Subjects Only}
Beschreibung

Child-bearing potential (Complete for Female Subjects Only}

Alias
UMLS CUI-1
C3831118 (Childbearing Potential)
Child-bearing potential
Beschreibung

Tick one. Post-menopausal = Women who have completed menopause at least one year ago. Sterile = Pre-menopausal women who cannot conceive children. (This category includes women who have become sterile through surgical procedures such as tubal ligation. Do not include post-menopausal women in this category.) Note: If the subject is sterile and is not of child-bearing age, then 'post-menopausal' will be the best choice and should be ticked. If the subject is sterile and does not know if she is post-menopausal and is less than 62 years of age, then she is of child-bearing age and 'sterile' should be ticked.

Datentyp

integer

Alias
UMLS CUI [1]
C3831118 (Childbearing Potential)
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Ähnliche Modelle

Serum pregnancy test, child-bearing potential

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Screening (1)
CL Item
Follow-up (2)
Item Group
Serum pregnancy test
C0430060 (UMLS CUI-1)
Date of test
Item
Date of test
date
C0011008 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
Item
Test result
integer
C0430060 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Test result
Code List
Test result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Child-bearing potential (Complete for Female Subjects Only}
C3831118 (UMLS CUI-1)
Item
Child-bearing potential
integer
C3831118 (UMLS CUI [1])
Child-bearing potential
Code List
Child-bearing potential
CL Item
Post-menopausal (1)
CL Item
Sterile (of child-bearing age) (2)
CL Item
Potentially able to bear children (3)
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