ID

34916

Beschrijving

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 Pregnancy notification form (subject). It has to be filled in if a pregnancy occurs during study. This form should be completed according to the protocol reporting requirements. Complete this form for each subject who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject's Case Report Form. Note: This form does not routinely need to be completed for subject's partner pregnancy unless there is specific instruction to do so stated in the protocol.

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  1. 04-02-19 04-02-19 -
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GlaxoSmithKline

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4 februari 2019

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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

Engels

Pregnancy notification form (subject)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschrijving

Centre Number

Datatype

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomisation Number
Beschrijving

Randomisation Number

Datatype

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Mothers relevant medical/family history
Beschrijving

Mothers relevant medical/family history

Alias
UMLS CUI-1
C0026591
UMLS CUI-2
C0262926
UMLS CUI-3
C0241889
Mother's date of birth
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0026591
UMLS CUI [1,2]
C0421451
Date of last menstrual period
Beschrijving

day month year.

Datatype

date

Alias
UMLS CUI [1]
C0425932
Estimated date of delivery
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1287845
Was the mother using a method of contraception?
Beschrijving

Use of contraceptive method

Datatype

text

Alias
UMLS CUI [1]
C0700589
If there was a use of a method of contraception, please specify
Beschrijving

Contraceptive method, specification

Datatype

text

Alias
UMLS CUI [1]
C0700589
Type of conception
Beschrijving

Tick one.

Datatype

integer

Alias
UMLS CUI [1]
C2598844
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures)
Beschrijving

Laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling)

Datatype

text

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C0041618
UMLS CUI [3]
C0002627
UMLS CUI [4]
C0008509
Number of previous pregnancies: Pre-term
Beschrijving

Number of previous pregnancies: Pre-term

Datatype

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C1547235
Number of previous pregnancies: Full-term
Beschrijving

Number of previous pregnancies: Full-term

Datatype

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C3814420
Normal Births
Beschrijving

If applicable, record the number

Datatype

integer

Alias
UMLS CUI [1]
C3665337
Stillbirths
Beschrijving

If applicable, record the number

Datatype

integer

Alias
UMLS CUI [1]
C0595939
Children born with defects
Beschrijving

If applicable, record the number

Datatype

integer

Alias
UMLS CUI [1]
C0000768
Spontaneous abortion
Beschrijving

If applicable, record the number

Datatype

integer

Alias
UMLS CUI [1]
C0000786
Elective abortion
Beschrijving

If applicable, record the number

Datatype

integer

Alias
UMLS CUI [1]
C0269439
Other
Beschrijving

If applicable, record the number

Datatype

integer

Alias
UMLS CUI [1]
C0205394
Record details of children born with defects
Beschrijving

Details of children born with defects

Datatype

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C0000768
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Beschrijving

Additional factors impacting pregnancy outcome

Datatype

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0032972
If there are any additional factors impacting pregnancy outcome, please specify
Beschrijving

Additional factors,specification

Datatype

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0032972
Fathers relevant medical/family history
Beschrijving

Fathers relevant medical/family history

Alias
UMLS CUI-1
C0015671
UMLS CUI-2
C0262926
UMLS CUI-3
C0241889
Fathers relevant medical/family history
Beschrijving

Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic/ chromosomal disorders and medication use

Datatype

text

Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0241889
Drug exposures
Beschrijving

Drug exposures

Alias
UMLS CUI-1
C0743284
Drug Name
Beschrijving

Trade name preferred

Datatype

text

Alias
UMLS CUI [1]
C0013227
Route of Administration or Formulation
Beschrijving

Route of Administration or Formulation

Datatype

text

Alias
UMLS CUI [1]
C0013153
Total Daily Dosis
Beschrijving

Total Daily Dosis

Datatype

text

Alias
UMLS CUI [1]
C2348070
Units, medication
Beschrijving

Units, medication

Datatype

text

Alias
UMLS CUI [1]
C1519795
Started pre-study?
Beschrijving

Start pre-study

Datatype

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
Start date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0808070
Stop date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0806020
Ongoing medication?
Beschrijving

Ongoing medication

Datatype

text

Alias
UMLS CUI [1]
C2826666
Reason for medication
Beschrijving

Reason for medication

Datatype

text

Alias
UMLS CUI [1]
C2826696
Was the subject withdrawn from the study as a result of this pregnancy?
Beschrijving

Withdrawl as result of pregnancy

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0032961
Reporting investigator information
Beschrijving

Reporting investigator information

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1533716
Name
Beschrijving

Name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Title
Beschrijving

Title

Datatype

text

Alias
UMLS CUI [1,1]
C3888414
UMLS CUI [1,2]
C0008961
Speciality
Beschrijving

Speciality

Datatype

text

Alias
UMLS CUI [1,1]
C0037778
UMLS CUI [1,2]
C0008961
Address
Beschrijving

Address

Datatype

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0008961
City or State/Province
Beschrijving

City or State/Province

Datatype

text

Alias
UMLS CUI [1]
C0008848
Country
Beschrijving

Country

Datatype

text

Alias
UMLS CUI [1]
C0454664
Post or Zip Code
Beschrijving

Post or Zip Code

Datatype

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C1514254
UMLS CUI [1,3]
C0600091
Telephone No
Beschrijving

Telephone No

Datatype

text

Alias
UMLS CUI [1]
C1515258
Fax No
Beschrijving

Fax No

Datatype

text

Alias
UMLS CUI [1]
C1549619
Investigator's signature
Beschrijving

confirming that the data on these pages are accurate and complete

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name (print)
Beschrijving

Investigator's name (print)

Datatype

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Pregnancy notification form (subject)

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])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Mothers relevant medical/family history
C0026591 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0241889 (UMLS CUI-3)
Mother's date of birth
Item
Mother's date of birth
date
C0026591 (UMLS CUI [1,1])
C0421451 (UMLS CUI [1,2])
Date of last menstrual period
Item
Date of last menstrual period
date
C0425932 (UMLS CUI [1])
Estimated date of delivery
Item
Estimated date of delivery
date
C1287845 (UMLS CUI [1])
Item
Was the mother using a method of contraception?
text
C0700589 (UMLS CUI [1])
Use of contraceptive method
Code List
Was the mother using a method of contraception?
CL Item
Yes (Y)
CL Item
No (N)
Contraceptive method, specification
Item
If there was a use of a method of contraception, please specify
text
C0700589 (UMLS CUI [1])
Item
Type of conception
integer
C2598844 (UMLS CUI [1])
Type of conception
Code List
Type of conception
CL Item
Normal (includes use of fertility drugs) (1)
CL Item
IVF (in vitro fertilisation) (2)
Laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling)
Item
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures)
text
C0022885 (UMLS CUI [1])
C0041618 (UMLS CUI [2])
C0002627 (UMLS CUI [3])
C0008509 (UMLS CUI [4])
Number of previous pregnancies: Pre-term
Item
Number of previous pregnancies: Pre-term
integer
C0422807 (UMLS CUI [1,1])
C1547235 (UMLS CUI [1,2])
Number of previous pregnancies: Full-term
Item
Number of previous pregnancies: Full-term
integer
C0422807 (UMLS CUI [1,1])
C3814420 (UMLS CUI [1,2])
Normal Births
Item
Normal Births
integer
C3665337 (UMLS CUI [1])
Stillbirths
Item
Stillbirths
integer
C0595939 (UMLS CUI [1])
Children born with defects
Item
Children born with defects
integer
C0000768 (UMLS CUI [1])
Spontaneous abortion
Item
Spontaneous abortion
integer
C0000786 (UMLS CUI [1])
Elective abortion
Item
Elective abortion
integer
C0269439 (UMLS CUI [1])
Other
Item
Other
integer
C0205394 (UMLS CUI [1])
Details of children born with defects
Item
Record details of children born with defects
text
C1522508 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
Item
Are there any additional factors that may have an impact on the outcome of this pregnancy?
text
C0035648 (UMLS CUI [1,1])
C0032972 (UMLS CUI [1,2])
Additional factors impacting pregnancy outcome
Code List
Are there any additional factors that may have an impact on the outcome of this pregnancy?
CL Item
Yes (Y)
CL Item
No (N)
Additional factors,specification
Item
If there are any additional factors impacting pregnancy outcome, please specify
text
C0035648 (UMLS CUI [1,1])
C0032972 (UMLS CUI [1,2])
Item Group
Fathers relevant medical/family history
C0015671 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0241889 (UMLS CUI-3)
Fathers relevant medical/family history
Item
Fathers relevant medical/family history
text
C0015671 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
Item Group
Drug exposures
C0743284 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Route of Administration or Formulation
Item
Route of Administration or Formulation
text
C0013153 (UMLS CUI [1])
Total Daily Dosis
Item
Total Daily Dosis
text
C2348070 (UMLS CUI [1])
Units, medication
Item
Units, medication
text
C1519795 (UMLS CUI [1])
Item
Started pre-study?
text
C0808070 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Start pre-study
Code List
Started pre-study?
CL Item
Yes (Y)
CL Item
No (N)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1])
Item
Ongoing medication?
text
C2826666 (UMLS CUI [1])
Ongoing medication
Code List
Ongoing medication?
CL Item
Yes (Y)
CL Item
No (N)
Reason for medication
Item
Reason for medication
text
C2826696 (UMLS CUI [1])
Item
Was the subject withdrawn from the study as a result of this pregnancy?
text
C0422727 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
Withdrawl as result of pregnancy
Code List
Was the subject withdrawn from the study as a result of this pregnancy?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Reporting investigator information
C0008961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Name
Item
Name
text
C2826892 (UMLS CUI [1])
Title
Item
Title
text
C3888414 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Speciality
Item
Speciality
text
C0037778 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
City or State/Province
Item
City or State/Province
text
C0008848 (UMLS CUI [1])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Post or Zip Code
Item
Post or Zip Code
text
C1442065 (UMLS CUI [1,1])
C1514254 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Telephone No
Item
Telephone No
text
C1515258 (UMLS CUI [1])
Fax No
Item
Fax No
text
C1549619 (UMLS CUI [1])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name (print)
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
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