ID

42302

Beschreibung

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

Stichworte

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  1. 18.05.21 18.05.21 -
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GlaxoSmithKline

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18. Mai 2021

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Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812

Englisch

Pregnancy Notification Form (Subject's Partner)

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Protocol Identifier
Beschreibung

Protocol Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

text

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

Randomisation Number

Datentyp

text

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

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
Beschreibung

Mother's date of birth

Datentyp

date

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

Date of last menstrual period

Datentyp

date

Alias
UMLS CUI [1]
C0425932
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

Was the mother using a method of contraception?

Datentyp

boolean

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

If mother was using method of contraception, please specify.

Datentyp

text

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

Check one

Datentyp

integer

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

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

Datentyp

text

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

Number of previous pregnancies (Pre-term)

Datentyp

integer

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

Number of previous pregnancies (Full-term)

Datentyp

integer

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

Number of normal births

Datentyp

integer

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

Number of Stillbirths

Datentyp

integer

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

Number of Children born with defects

Datentyp

integer

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

Number of Spontaneous abortions

Datentyp

integer

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

Number of Elective abortions

Datentyp

integer

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

Number of other births

Datentyp

integer

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

Record details of children born with birth defects

Datentyp

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?
Beschreibung

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

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

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
Beschreibung

Father's Relevant Medical/Family History

Datentyp

text

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

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
Beschreibung

Drug Name

Datentyp

text

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

Route of Administration or Formulation

Datentyp

text

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

Total Daily Dose

Datentyp

float

Alias
UMLS CUI [1]
C2348070
Units
Beschreibung

Units

Datentyp

text

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

Medication Started Pre-Study

Datentyp

boolean

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

Medication Start Date

Datentyp

date

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

Medication Stop Date

Datentyp

date

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

Ongoing Medication

Datentyp

boolean

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

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?
Beschreibung

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

Datentyp

boolean

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

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
Beschreibung

Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Title
Beschreibung

Title

Datentyp

text

Alias
UMLS CUI [1]
C3888414
Speciality
Beschreibung

Speciality

Datentyp

text

Alias
UMLS CUI [1]
C0037778
Adress
Beschreibung

Adress

Datentyp

text

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

City or State/Province

Datentyp

text

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

Country

Datentyp

text

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

Post or Zip Code

Datentyp

text

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

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

Datentyp

text

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

Investigator's Signature Date

Datentyp

date

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

Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Pregnancy Notification Form (Subject's Partner)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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