ID

35645

Beschreibung

Study ID: 103268 Clinical Study ID: 103268 Study Title: An Open Label, Randomised, Single Dose, Three-way Crossover Study to Investigate the Relative Bioavailability of Two Different Formulations of GSK163090 and the Effect of Food on the Pharmacokinetics of a Tablet Formulation in Healthy Male and Female Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00536679 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK163090 capsule, fasted/fed Trade Name: N/A Study Indication: Depression; Depressive Disorder and Anxiety Disorders

Stichworte

Versionen (1)
  1. 13.03.19 13.03.19 -
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GSK group of companies

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13. März 2019

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the Effect of Food on the Pharmacokinetics of a Tablet Formulation - 103268

Englisch

Pregnancy Report

1 Formulare  
  1. StudyEvent: ODM
    1. Pregnancy Report
Administrative data
Beschreibung

Administrative data

Visit Number
Beschreibung

Visit Number

Datentyp

text

Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Pregnancy Notification Form
Beschreibung

Pregnancy Notification Form

Alias
UMLS CUI-1
C0032961
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Mothers date of birth
Beschreibung

Mothers date of birth

Datentyp

date

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

Date of last menstrual period

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0025329
Estimated date of delivery
Beschreibung

Estimated date of delivery

Datentyp

date

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

contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
If Yes, please specify
Beschreibung

Was the mother using a method of contraception?

Datentyp

text

Alias
UMLS CUI [1]
C0700589
Type of conception, check one:
Beschreibung

Type of conception

Datentyp

integer

Alias
UMLS CUI [1]
C2598844
Relevant laboratory tests
Beschreibung

Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).

Datentyp

text

Alias
UMLS CUI [1]
C0022885
laboratory test date
Beschreibung

Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Relevant procedures
Beschreibung

Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).

Datentyp

text

Alias
UMLS CUI [1]
C0430022
procedure date
Beschreibung

Relevant laboratory tests and procedures (e.g., ultrasound, aminocentesis and chorionic villi sampling, including dates of tests and procedures).

Datentyp

date

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0011008
Number of previous pregnancies: Pre-term
Beschreibung

Pre-term pregnancies

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1547235
UMLS CUI [1,3]
C0449788
Number of previous pregnancies: Full-term
Beschreibung

Full-term pregnancy

Datentyp

integer

Alias
UMLS CUI [1,1]
C2114495
UMLS CUI [1,2]
C0449788
Number of: Normal births
Beschreibung

Normal births

Datentyp

integer

Alias
UMLS CUI [1,1]
C3665337
UMLS CUI [1,2]
C0449788
Number of: Stillbirths
Beschreibung

Stillbirths

Datentyp

integer

Alias
UMLS CUI [1,1]
C0595939
UMLS CUI [1,2]
C0449788
Number of: Children born with defects
Beschreibung

Children born with defects

Datentyp

integer

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0449788
Record details of children born with defects
Beschreibung

Children born with defects

Datentyp

text

Alias
UMLS CUI [1]
C0000768
Number of: Spontaneous abortion
Beschreibung

Spontaneous abortion

Datentyp

integer

Alias
UMLS CUI [1,1]
C0000786
UMLS CUI [1,2]
C0449788
Number of: Elective abortion
Beschreibung

Elective abortion

Datentyp

integer

Alias
UMLS CUI [1,1]
C0269439
UMLS CUI [1,2]
C0449788
Number of: Other
Beschreibung

other birth

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005615
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0449788
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Beschreibung

impact on the outcome of this pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032972
UMLS CUI [1,2]
C1521761
If Yes, please specify
Beschreibung

Are there any additional factors that may have an impact on the outcome of this pregnancy?

Datentyp

text

Alias
UMLS CUI [1,1]
C0032972
UMLS CUI [1,2]
C1521761
Fathers relevant medical/family history
Beschreibung

Fathers relevant medical/family history

Datentyp

text

Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C0241889
Was the subject withdrawn from the study as a result of this pregnancy?
Beschreibung

withdrawn from the study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0032961
Drug Exposures
Beschreibung

Drug Exposures

Alias
UMLS CUI-1
C0743284
Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Route of Admin. or Formulation
Beschreibung

Route of Admin. or Formulation

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

text

Alias
UMLS CUI [1]
C2348070
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Started Pre-Study
Beschreibung

Started Pre-Study

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0451613
Start Date
Beschreibung

Start Date

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Day Month Year
Stop Date
Beschreibung

Stop Date

Datentyp

date

Maßeinheiten
  • Day Month Year
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Day Month Year
Ongoing Medication
Beschreibung

Ongoing Medication

Datentyp

text

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
REPORTING INVESTIGATOR INFORMATION
Beschreibung

REPORTING INVESTIGATOR INFORMATION

Alias
UMLS CUI-1
C1955348
UMLS CUI-2
C0008961
Name
Beschreibung

Name

Datentyp

text

Alias
UMLS CUI [1]
C0008961
Title
Beschreibung

Title

Datentyp

text

Alias
UMLS CUI [1]
C3888414
Speciality
Beschreibung

Speciality

Datentyp

text

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

Address

Datentyp

text

Alias
UMLS CUI [1]
C1442065
City or State/Province
Beschreibung

City

Datentyp

text

Alias
UMLS CUI [1]
C0008848
Country
Beschreibung

Country

Datentyp

text

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

Zip Code

Datentyp

integer

Alias
UMLS CUI [1]
C0421454
Telephone No
Beschreibung

Telephone No

Datentyp

integer

Alias
UMLS CUI [1]
C1515258
Fax No
Beschreibung

Fax No

Datentyp

integer

Alias
UMLS CUI [1]
C1549619
Investigator’s signature
Beschreibung

Investigator signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator’s name
Beschreibung

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
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Ähnliche Modelle

Pregnancy Report

1 Formulare
  1. StudyEvent: ODM
    1. Pregnancy Report
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
Visit 1 (1)
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Pregnancy Notification Form
C0032961 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Mothers date of birth
Item
Mothers 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
C0011008 (UMLS CUI [1,1])
C0025329 (UMLS CUI [1,2])
Estimated date of delivery
Item
Estimated date of delivery
date
C1287845 (UMLS CUI [1])
contraception
Item
Was the mother using a method of contraception?
boolean
C0700589 (UMLS CUI [1])
contraception
Item
If Yes, please specify
text
C0700589 (UMLS CUI [1])
Item
Type of conception, check one:
integer
C2598844 (UMLS CUI [1])
Type of conception
Code List
Type of conception, check one:
CL Item
Normal (includes use of fertility drugs) (1)
CL Item
IVF (in vitro fertilisation) (2)
laboratory tests
Item
Relevant laboratory tests
text
C0022885 (UMLS CUI [1])
laboratory test date
Item
laboratory test date
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
procedure
Item
Relevant procedures
text
C0430022 (UMLS CUI [1])
procedure date
Item
procedure date
date
C0430022 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pre-term pregnancies
Item
Number of previous pregnancies: Pre-term
integer
C0032961 (UMLS CUI [1,1])
C1547235 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Full-term pregnancy
Item
Number of previous pregnancies: Full-term
integer
C2114495 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Normal births
Item
Number of: Normal births
integer
C3665337 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Stillbirths
Item
Number of: Stillbirths
integer
C0595939 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Children born with defects
Item
Number of: Children born with defects
integer
C0000768 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Children born with defects
Item
Record details of children born with defects
text
C0000768 (UMLS CUI [1])
Spontaneous abortion
Item
Number of: Spontaneous abortion
integer
C0000786 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Elective abortion
Item
Number of: Elective abortion
integer
C0269439 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
other birth
Item
Number of: Other
integer
C0005615 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
impact on the outcome of this pregnancy
Item
Are there any additional factors that may have an impact on the outcome of this pregnancy?
boolean
C0032972 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
impact on the outcome of this pregnancy
Item
If Yes, please specify
text
C0032972 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
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 [2])
withdrawn from the study
Item
Was the subject withdrawn from the study as a result of this pregnancy?
boolean
C0422727 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
Item Group
Drug Exposures
C0743284 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Route of Admin. or Formulation
Item
Route of Admin. or Formulation
text
C0013153 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Started Pre-Study
text
C0013227 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
Started Pre-Study
Code List
Started Pre-Study
CL Item
Yes (Y)
CL Item
No (N)
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
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
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
REPORTING INVESTIGATOR INFORMATION
C1955348 (UMLS CUI-1)
C0008961 (UMLS CUI-2)
Name
Item
Name
text
C0008961 (UMLS CUI [1])
Title
Item
Title
text
C3888414 (UMLS CUI [1])
Speciality
Item
Speciality
text
C0037778 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Address
Item
Address
text
C1442065 (UMLS CUI [1])
City
Item
City or State/Province
text
C0008848 (UMLS CUI [1])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Zip Code
Item
Post or Zip Code
integer
C0421454 (UMLS CUI [1])
Telephone No
Item
Telephone No
integer
C1515258 (UMLS CUI [1])
Fax No
Item
Fax No
integer
C1549619 (UMLS CUI [1])
Investigator signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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