ID

30929

Beskrivning

This ODM file contains pregnancy notification form for the female partner of a male subject as well as a female subject. This form should be completed according to the protocol reporting requirements. Complete this form for each subject(’s partner) 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. All of the header information must be completed before sending back to GSK. 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. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Länk

https://clinicaltrials.gov/ct2/show/NCT01039454

Nyckelord

Versioner (2)
  1. 2018-07-03 2018-07-03 - Sarah Riepenhausen
  2. 2018-07-03 2018-07-03 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 juli 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

Engelsk

Pregnancy Notification Form

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Protocol Identifier
Beskrivning

Protocol Identifier

Datatyp

text

Alias
UMLS CUI [1]
C4331034
Centre number
Beskrivning

Centre number

Datatyp

text

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

Randomisation Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Who is pregnant? Subject or Subject's Partner?
Beskrivning

Pregnant Person

Datatyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1997894
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0682323
Mother's relevant medical/family history
Beskrivning

Mother's relevant medical/family history

Alias
UMLS CUI-1
C0026591
UMLS CUI-2
C0262926
UMLS CUI-3
C0241889
Mother's Date of Birth
Beskrivning

Mother's Date of Birth

Datatyp

date

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

Date of last menstrual period

Datatyp

date

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

Estimated date of delivery

Datatyp

date

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

Contraception

Datatyp

text

Alias
UMLS CUI [1]
C0420837
If Yes, specify
Beskrivning

Method of Contraception

Datatyp

text

Alias
UMLS CUI [1]
C0700589
Type of Conception
Beskrivning

Type of Conception

Datatyp

text

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

Relevant laboratory tests and procedures

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0032961
UMLS CUI [2,1]
C0430022
UMLS CUI [2,2]
C0032961
Number of Previous Pre-term pregnancies
Beskrivning

Number of Previous Pre-term pregnancies

Datatyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C1547235
Number of Previous Full-term pregnancies
Beskrivning

Number of Previous Full-term pregnancies

Datatyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C3814420
Number of normal births
Beskrivning

Number of normal births

Datatyp

integer

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

Number of Stillbirths

Datatyp

integer

Alias
UMLS CUI [1,1]
C0595939
UMLS CUI [1,2]
C0449788
Number of children born with defects
Beskrivning

Number of children born with defects

Datatyp

integer

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

Details of birth defects in children

Datatyp

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C0000768
Number of Spontaneous abortions
Beskrivning

Number of Spontaneous abortions

Datatyp

integer

Alias
UMLS CUI [1,1]
C0000786
UMLS CUI [1,2]
C0449788
Number of Elective Abortions
Beskrivning

Number of Elective Abortions

Datatyp

integer

Alias
UMLS CUI [1,1]
C0269439
UMLS CUI [1,2]
C0449788
Number of other pregnancies/births
Beskrivning

Number of other pregnancies/births

Datatyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C0205394
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Beskrivning

additional risk factors for this pregnancy

Datatyp

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0747843
If yes, specify
Beskrivning

additional risk factors for this pregnancy, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0747843
UMLS CUI [1,3]
C1521902
Father's Relevant Medical/Family History
Beskrivning

Father's Relevant Medical/Family History

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0241889
UMLS CUI-3
C0015671
Father's Relevant Medical/Family History
Beskrivning

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

Datatyp

text

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

Drug exposures

Alias
UMLS CUI-1
C0743284
UMLS CUI-2
C0032961
Drug Name
Beskrivning

Trade Name preferred. List all medications (including study medications) the subject received during the study period (e.g. prescription, OTC, vaccines, recreational, alcohol, etc.) and fill out the other items of this itemgroup for each drug. Enter the investigational product details on the first line (if the investigational product is blinded, enter ’Investigational Product’ on this line). If there are extensive concomitant medications, attach a copy of the Concomitant Medications CRF page.

Datatyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0013227
Route of Admin. or Formulation
Beskrivning

Route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Total Daily Dose
Beskrivning

Total Daily Dose

Datatyp

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0013227
Started Pre-Study
Beskrivning

Started Pre-Study

Datatyp

boolean

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

Start Date

Datatyp

date

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

Stop Date

Datatyp

date

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

Ongoing Medication

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beskrivning

Reason for Medication

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Subject withdrawal
Beskrivning

Subject withdrawal

Alias
UMLS CUI-1
C0422727
UMLS CUI-2
C0032961
Was the subject withdrawn from the study as a result of this pregnancy?
Beskrivning

Subject withdrawal

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0032961
REPORTING INVESTIGATOR INFORMATION
Beskrivning

REPORTING INVESTIGATOR INFORMATION

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

Name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Title
Beskrivning

Title

Datatyp

text

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

Speciality

Datatyp

text

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

Address

Datatyp

text

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

City

Datatyp

text

Alias
UMLS CUI [1,1]
C0008848
UMLS CUI [1,2]
C0008961
Country
Beskrivning

Country

Datatyp

text

Alias
UMLS CUI [1,1]
C0454664
UMLS CUI [1,2]
C0008961
Post or Zip Code
Beskrivning

Zip Code

Datatyp

text

Alias
UMLS CUI [1,1]
C0421454
UMLS CUI [1,2]
C0008961
Telephone No
Beskrivning

Telephone No

Datatyp

integer

Alias
UMLS CUI [1,1]
C1515258
UMLS CUI [1,2]
C0008961
Fax No
Beskrivning

Fax No

Datatyp

integer

Alias
UMLS CUI [1,1]
C1549619
UMLS CUI [1,2]
C0008961
Investigator’s signature confirming that the data on these pages are accurate and complete
Beskrivning

Investigator signature

Datatyp

text

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

Investigator name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Pregnancy Notification Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Protocol Identifier
Item
Protocol Identifier
text
C4331034 (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
Who is pregnant? Subject or Subject's Partner?
text
C0032961 (UMLS CUI [1,1])
C1997894 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
Pregnant Person
Code List
Who is pregnant? Subject or Subject's Partner?
CL Item
Subject (Subject)
CL Item
Subject's Partner (Subject's Partner)
Item Group
Mother's 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
C0420837 (UMLS CUI [1])
Contraception
Code List
Was the mother using a method of contraception?
CL Item
Yes (Y)
CL Item
No (N)
Method of Contraception
Item
If Yes, specify
text
C0700589 (UMLS CUI [1])
Item
Type of Conception
text
C2598844 (UMLS CUI [1])
Type of Conception
Code List
Type of Conception
CL Item
Normal (includes use of fertility drugs) (Normal (includes use of fertility drugs))
CL Item
IVF (in vitro fertilisation) (IVF (in vitro fertilisation))
Relevant laboratory tests and procedures
Item
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
text
C0022885 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0430022 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
Number of Previous Pre-term pregnancies
Item
Number of Previous Pre-term pregnancies
integer
C0422807 (UMLS CUI [1,1])
C1547235 (UMLS CUI [1,2])
Number of Previous Full-term pregnancies
Item
Number of Previous Full-term pregnancies
integer
C0422807 (UMLS CUI [1,1])
C3814420 (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])
C0449788 (UMLS CUI [1,2])
Details of birth defects in children
Item
Record details of children born with defects
text
C1522508 (UMLS CUI [1,1])
C0000768 (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 pregnancies/births
Item
Number of other pregnancies/births
integer
C0422807 (UMLS CUI [1,1])
C0205394 (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])
C0747843 (UMLS CUI [1,2])
Contraception
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 risk factors for this pregnancy, specify
Item
If yes, specify
text
C0035648 (UMLS CUI [1,1])
C0747843 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Father's Relevant Medical/Family History
C0262926 (UMLS CUI-1)
C0241889 (UMLS CUI-2)
C0015671 (UMLS CUI-3)
Father's Relevant Medical/Family History
Item
Father's Relevant Medical/Family History
text
C0262926 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0015671 (UMLS CUI [1,3])
Item Group
Drug exposures
C0743284 (UMLS CUI-1)
C0032961 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Route
Item
Route of Admin. or Formulation
text
C0013153 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Units
Item
Units
text
C1519795 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Started Pre-Study
Item
Started Pre-Study
boolean
C0013227 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
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])
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
Subject withdrawal
C0422727 (UMLS CUI-1)
C0032961 (UMLS CUI-2)
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])
Subject withdrawal
Code List
Was the subject withdrawn from the study as a result of this pregnancy?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
REPORTING INVESTIGATOR INFORMATION
C1955348 (UMLS CUI-1)
C0008961 (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
Item
City or State/Province
text
C0008848 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Zip Code
Item
Post or Zip Code
text
C0421454 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Telephone No
Item
Telephone No
integer
C1515258 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Fax No
Item
Fax No
integer
C1549619 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Investigator signature
Item
Investigator’s signature confirming that the data on these pages are accurate and complete
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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