ID

42302

Descrição

Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases

Palavras-chave

Versões (1)
  1. 18/05/2021 18/05/2021 -
Titular dos direitos

GlaxoSmithKline

Transferido a

18 de maio de 2021

DOI

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Licença

Creative Commons BY 4.0
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Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812

Inglês

Pregnancy Notification Form (Subject's Partner)

1 Formulários  
Administrative
Descrição

Administrative

Alias
UMLS CUI-1
C1320722
Protocol Identifier
Descrição

Protocol Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Descrição

Centre Number

Tipo de dados

text

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

Randomisation Number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Pregnancy Notification Form (Subject's Partner) - Mother's Relevant Medical/Family History
Descrição

Pregnancy Notification Form (Subject's Partner) - Mother's Relevant Medical/Family History

Alias
UMLS CUI-1
C0032961
UMLS CUI-3
C1533716
UMLS CUI-5
C3887537
UMLS CUI-7
C0026591
UMLS CUI-9
C0262926
UMLS CUI-11
C0241889
Mother's date of birth
Descrição

Mother's date of birth

Tipo de dados

date

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

Date of last menstrual period

Tipo de dados

date

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

Estimated date of delivery

Tipo de dados

date

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

Was the mother using a method of contraception?

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
If mother was using method of contraception, please specify.
Descrição

If mother was using method of contraception, please specify.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C2348235
Type of conception
Descrição

Check one

Tipo de dados

integer

Alias
UMLS CUI [1]
C2598844
Relevant laboratory tests and procedures
Descrição

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

Tipo de dados

text

Alias
UMLS CUI [1]
C0022885
Number of previous pregnancies (Pre-term)
Descrição

Number of previous pregnancies (Pre-term)

Tipo de dados

integer

Alias
UMLS CUI [1]
C0422807
UMLS CUI [2]
C1547235
Number of previous pregnancies (Full-term)
Descrição

Number of previous pregnancies (Full-term)

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2114495
UMLS CUI [1,2]
C0449788
Number of normal births
Descrição

Number of normal births

Tipo de dados

integer

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

Number of Stillbirths

Tipo de dados

integer

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

Number of Children born with defects

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C2229974
Number of Spontaneous abortions
Descrição

Number of Spontaneous abortions

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0000786
UMLS CUI [1,2]
C0449788
Number of Elective abortions
Descrição

Number of Elective abortions

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0269439
UMLS CUI [1,2]
C0449788
Number of other births
Descrição

Number of other births

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C3172256
UMLS CUI [1,2]
C0205394
Record details of children born with birth defects
Descrição

Record details of children born with birth defects

Tipo de dados

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?
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032972
UMLS CUI [2]
C1521761
Specify factor that may have an impact on the outcome of this pregnancy
Descrição

Specify factor that may have an impact on the outcome of this pregnancy

Tipo de dados

text

Alias
UMLS CUI [1]
C0032972
UMLS CUI [2]
C1521761
UMLS CUI [3]
C2348235
Pregnancy Notification Form (Subject's Partner) - Father's Relevant Medical/Family History
Descrição

Pregnancy Notification Form (Subject's Partner) - Father's Relevant Medical/Family History

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
UMLS CUI-3
C3887537
UMLS CUI-4
C0015671
UMLS CUI-5
C0262926
UMLS CUI-6
C0241889
Father's Relevant Medical/Family History
Descrição

Father's Relevant Medical/Family History

Tipo de dados

text

Alias
UMLS CUI [1]
C0015671
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0241889
Pregnancy Notification Form (Subject's Partner) - Drug Exposures
Descrição

Pregnancy Notification Form (Subject's Partner) - Drug Exposures

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
UMLS CUI-3
C3887537
UMLS CUI-4
C0743284
Drug Name
Descrição

Drug Name

Tipo de dados

text

Alias
UMLS CUI [1]
C2360065
Route of Administration or Formulation
Descrição

Route of Administration or Formulation

Tipo de dados

text

Alias
UMLS CUI [1]
C0013153
UMLS CUI [2]
C1705957
Total Daily Dose
Descrição

Total Daily Dose

Tipo de dados

float

Alias
UMLS CUI [1]
C2348070
Units
Descrição

Units

Tipo de dados

text

Alias
UMLS CUI [1]
C1519795
Medication Started Pre-Study
Descrição

Medication Started Pre-Study

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2,1]
C0808070
UMLS CUI [2,2]
C0332152
UMLS CUI [3]
C2347804
Medication Start Date
Descrição

Medication Start Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication Stop Date
Descrição

Medication Stop Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Ongoing Medication
Descrição

Ongoing Medication

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Descrição

Reason for Medication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Was the subject withdrawn from the study as a result of this pregnancy?
Descrição

Was the subject withdrawn from the study as a result of this pregnancy?

Alias
UMLS CUI-1
C0422727
UMLS CUI-3
C0032961
Was the subject withdrawn from the study as a result of this pregnancy?
Descrição

Was the subject withdrawn from the study as a result of this pregnancy?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0032961
Pregnancy Notification Form (Subject's Partner) - Reporting Investigator Information
Descrição

Pregnancy Notification Form (Subject's Partner) - Reporting Investigator Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
UMLS CUI-3
C3887537
UMLS CUI-5
C0008961
UMLS CUI-6
C1533716
Name
Descrição

Name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
Title
Descrição

Title

Tipo de dados

text

Alias
UMLS CUI [1]
C3888414
Speciality
Descrição

Speciality

Tipo de dados

text

Alias
UMLS CUI [1]
C0037778
Adress
Descrição

Adress

Tipo de dados

text

Alias
UMLS CUI [1]
C1301826
City or State/Province
Descrição

City or State/Province

Tipo de dados

text

Alias
UMLS CUI [1]
C0008848
UMLS CUI [2]
C1547742
Country
Descrição

Country

Tipo de dados

text

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

Post or Zip Code

Tipo de dados

text

Alias
UMLS CUI [1]
C0421454
Telephone No
Descrição

Telephone No

Tipo de dados

integer

Alias
UMLS CUI [1]
C1515258
Fax No
Descrição

Fax No

Tipo de dados

integer

Alias
UMLS CUI [1]
C1549619
Investigator's Signature
Descrição

(confirming that the data on these pages are accurate and complete)

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Descrição

Investigator's Signature Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name
Descrição

Investigator's name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Pregnancy Notification Form (Subject's Partner)

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Protocol Identifier
Item
Protocol Identifier
text
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
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
Pregnancy Notification Form (Subject's Partner) - Mother's Relevant Medical/Family History
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-3)
C3887537 (UMLS CUI-5)
C0026591 (UMLS CUI-7)
C0262926 (UMLS CUI-9)
C0241889 (UMLS CUI-11)
Mother's date of birth
Item
Mother's date of birth
date
C0026591 (UMLS CUI [1])
C0421451 (UMLS CUI [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])
Was the mother using a method of contraception?
Item
Was the mother using a method of contraception?
boolean
C0700589 (UMLS CUI [1])
If mother was using method of contraception, please specify.
Item
If mother was using method of contraception, please specify.
text
C0700589 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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)
Relevant laboratory tests and procedures
Item
Relevant laboratory tests and procedures
text
C0022885 (UMLS CUI [1])
Number of previous pregnancies (Pre-term)
Item
Number of previous pregnancies (Pre-term)
integer
C0422807 (UMLS CUI [1])
C1547235 (UMLS CUI [2])
Number of previous pregnancies (Full-term)
Item
Number of previous pregnancies (Full-term)
integer
C2114495 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of normal births
Item
Number of normal births
integer
C3665337 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of Stillbirths
Item
Number of Stillbirths
integer
C0595939 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of Children born with defects
Item
Number of Children born with defects
integer
C0000768 (UMLS CUI [1,1])
C2229974 (UMLS CUI [1,2])
Number of Spontaneous abortions
Item
Number of Spontaneous abortions
integer
C0000786 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of Elective abortions
Item
Number of Elective abortions
integer
C0269439 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of other births
Item
Number of other births
integer
C3172256 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Record details of children born with birth defects
Item
Record details of children born with birth defects
text
C1522508 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
Are there any additional factors that may have an 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])
C1521761 (UMLS CUI [2])
Specify factor that may have an impact on the outcome of this pregnancy
Item
Specify factor that may have an impact on the outcome of this pregnancy
text
C0032972 (UMLS CUI [1])
C1521761 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item Group
Pregnancy Notification Form (Subject's Partner) - Father's Relevant Medical/Family History
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C3887537 (UMLS CUI-3)
C0015671 (UMLS CUI-4)
C0262926 (UMLS CUI-5)
C0241889 (UMLS CUI-6)
Father's Relevant Medical/Family History
Item
Father's Relevant Medical/Family History
text
C0015671 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0241889 (UMLS CUI [3])
Item Group
Pregnancy Notification Form (Subject's Partner) - Drug Exposures
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C3887537 (UMLS CUI-3)
C0743284 (UMLS CUI-4)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Route of Administration or Formulation
Item
Route of Administration or Formulation
text
C0013153 (UMLS CUI [1])
C1705957 (UMLS CUI [2])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Medication Started Pre-Study
Item
Medication Started Pre-Study
boolean
C0013227 (UMLS CUI [1])
C0808070 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C2347804 (UMLS CUI [3])
Medication Start Date
Item
Medication Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication Stop Date
Item
Medication Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Ongoing Medication
Item
Ongoing Medication
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Was the subject withdrawn from the study as a result of this pregnancy?
C0422727 (UMLS CUI-1)
C0032961 (UMLS CUI-3)
Was the subject withdrawn from the study as a result of this pregnancy?
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
Pregnancy Notification Form (Subject's Partner) - Reporting Investigator Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C3887537 (UMLS CUI-3)
C0008961 (UMLS CUI-5)
C1533716 (UMLS CUI-6)
Name
Item
Name
text
C2826892 (UMLS CUI [1])
Title
Item
Title
text
C3888414 (UMLS CUI [1])
Speciality
Item
Speciality
text
C0037778 (UMLS CUI [1])
Adress
Item
Adress
text
C1301826 (UMLS CUI [1])
City or State/Province
Item
City or State/Province
text
C0008848 (UMLS CUI [1])
C1547742 (UMLS CUI [2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Post or Zip Code
Item
Post or Zip Code
text
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's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
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