ID

23863

Beskrivning

Study part: Pregnancy Notification Form (Subject) Week 36/ Early Withdrawal Visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Nyckelord

Versioner (1)
  1. 2017-07-15 2017-07-15 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 juli 2017

DOI

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Creative Commons BY-NC 3.0
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Pregnancy Notification Form (Subject) Week 36 Mepolizumab HES NCT00086658

Engelsk

Pregnancy Notification Form (Subject) Week 36

1 Formulär  
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
Beskrivning

MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY

Alias
UMLS CUI-1
C0241889
UMLS CUI-2
C0026591
Subject ID
Beskrivning

Subject ID

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beskrivning

Centre Number

Datatyp

integer

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

Randomisation Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0034656
Mother’s date of birth
Beskrivning

date of birth mother

Datatyp

date

Alias
UMLS CUI [1,1]
C0421451
UMLS CUI [1,2]
C0026591
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

method of contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
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

laboratory tests

Datatyp

text

Alias
UMLS CUI [1]
C0022885
Number of previous pregnancies-Pre-term
Beskrivning

Number of previous pregnancies Pre-term

Datatyp

integer

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

Number of previous pregnancies Full-term

Datatyp

integer

Alias
UMLS CUI [1,1]
C0422807
UMLS CUI [1,2]
C3814420
Normal births
Beskrivning

Normal births

Datatyp

integer

Alias
UMLS CUI [1]
C3665337
Stillbirths
Beskrivning

Stillbirths

Datatyp

integer

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

Children born with defects

Datatyp

integer

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C2229974
Spontaneous abortion
Beskrivning

Spontaneous abortion

Datatyp

integer

Alias
UMLS CUI [1]
C0000786
Elective abortion
Beskrivning

Elective abortion

Datatyp

integer

Alias
UMLS CUI [1]
C0269439
If other, please specify
Beskrivning

Other

Datatyp

text

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

Children born with defects

Datatyp

text

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C2229974
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Beskrivning

pregnancy outcome

Datatyp

text

Alias
UMLS CUI [1]
C0032972
If Yes, specify
Beskrivning

pregnancy outcome

Datatyp

text

Alias
UMLS CUI [1]
C0032972
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
Beskrivning

FATHER’S RELEVANT MEDICAL/FAMILY HISTORY

Alias
UMLS CUI-1
C0241889
UMLS CUI-2
C0015671
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY (Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic/chromosomal disorders and medication use)
Beskrivning

Family history father substance use disorder

Datatyp

text

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0015671
UMLS CUI [1,3]
C0038586
Drug Name
Beskrivning

Drug Name

Datatyp

text

Alias
UMLS CUI [1]
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]
C2348070
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1]
C1519795
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]
C0808070
Stop Date
Beskrivning

Stop Date

Datatyp

date

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

withdrawn from the study

Datatyp

boolean

Alias
UMLS CUI [1]
C0422727
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]
C0008961
Title
Beskrivning

Title

Datatyp

text

Alias
UMLS CUI [1]
C3888414
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]
C1442065
City or State/Province
Beskrivning

City

Datatyp

text

Alias
UMLS CUI [1]
C0008848
Country
Beskrivning

Country

Datatyp

text

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

Zip Code

Datatyp

integer

Alias
UMLS CUI [1]
C0421454
Telephone No
Beskrivning

Telephone No

Datatyp

integer

Alias
UMLS CUI [1]
C1515258
Fax No
Beskrivning

Fax No

Datatyp

integer

Alias
UMLS CUI [1]
C1549619
Investigator’s signature
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]
C0011008
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Similar models

Pregnancy Notification Form (Subject) Week 36

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
C0241889 (UMLS CUI-1)
C0026591 (UMLS CUI-2)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0449788 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
date of birth mother
Item
Mother’s date of birth
date
C0421451 (UMLS CUI [1,1])
C0026591 (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])
method of contraception
Item
Was the mother using a method of contraception?
boolean
C0700589 (UMLS CUI [1])
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))
C0015915 (UMLS CUI-1)
laboratory tests
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])
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 [1,1])
C2229974 (UMLS CUI [1,2])
Spontaneous abortion
Item
Spontaneous abortion
integer
C0000786 (UMLS CUI [1])
Elective abortion
Item
Elective abortion
integer
C0269439 (UMLS CUI [1])
Other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
Children born with defects
Item
Record details of children born with defects
text
C0000768 (UMLS CUI [1,1])
C2229974 (UMLS CUI [1,2])
pregnancy outcome
Item
Are there any additional factors that may have an impact on the outcome of this pregnancy?
text
C0032972 (UMLS CUI [1])
pregnancy outcome
Item
If Yes, specify
text
C0032972 (UMLS CUI [1])
Item Group
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
C0241889 (UMLS CUI-1)
C0015671 (UMLS CUI-2)
Family history father substance use disorder
Item
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY (Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic/chromosomal disorders and medication use)
text
C0241889 (UMLS CUI [1,1])
C0015671 (UMLS CUI [1,2])
C0038586 (UMLS CUI [1,3])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Route
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])
Started Pre-Study
Item
Started Pre-Study
boolean
C0013227 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
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])
withdrawn from the study
Item
Was the subject withdrawn from the study as a result of this pregnancy?
boolean
C0422727 (UMLS CUI [1])
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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