ID

23862

Description

Study part: Pregnancy Follow- Up Form- Current Pregnancy Information 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.

Keywords

  1. 7/15/17 7/15/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 15, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Pregnancy Follow- Up Form- Current Pregnancy Information Week 36 Mepolizumab HES NCT00086658

Pregnancy Follow- Up Form- Current Pregnancy Information Week 36

PREGNANCY FOLLOW-UP FORM
Description

PREGNANCY FOLLOW-UP FORM

Alias
UMLS CUI-1
C1522577
UMLS CUI-2
C0032961
Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

integer

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

Randomisation Number

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0034656
PREGNANCY STATUS
Description

PREGNANCY STATUS

Data type

text

Alias
UMLS CUI [1]
C0552579
Method used for delivery, specify
Description

delivery method

Data type

text

Alias
UMLS CUI [1]
C0565867
Early termination
Description

Abortion

Data type

text

Alias
UMLS CUI [1]
C0156543
If other, please specify
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
FOETAL/NEONATAL STATUS
Description

NEONATAL STATUS

Data type

text

Alias
UMLS CUI [1]
C3533197
If birth defects are diagnosed, is the origin of the defect known?
Description

birth defect

Data type

boolean

Alias
UMLS CUI [1]
C0000768
If Yes, specify
Description

birth defect

Data type

text

Alias
UMLS CUI [1]
C0000768
INFANT INFORMATION
Description

INFANT INFORMATION

Alias
UMLS CUI-1
C3840300
Date of birth/miscarriage/termination
Description

Date of birth

Data type

date

Alias
UMLS CUI [1,1]
C0421451
UMLS CUI [1,2]
C0000814
Gestational weeks at birth/miscarriage/termination
Description

Gestational weeks at birth miscarriage

Data type

integer

Measurement units
  • Weeks
Alias
UMLS CUI [1,1]
C2011191
UMLS CUI [1,2]
C0000814
Weeks
Infant’s sex
Description

sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Length
Description

Length

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C1444754
cm
Weight
Description

Weight

Data type

float

Measurement units
  • g
Alias
UMLS CUI [1]
C0005910
g
Apgar score (0 - 10) First assessment
Description

Apgar score

Data type

integer

Alias
UMLS CUI [1]
C0003533
Apgar score (0 - 10) Second assessment
Description

Apgar score

Data type

integer

Alias
UMLS CUI [1]
C0003533
PREGNANCY INFORMATION
Description

PREGNANCY INFORMATION

Alias
UMLS CUI-1
C0032961
ADDITIONAL DETAILS (Provide additional details on current labour/delivery/discharge notes etc.)
Description

Information labour delivery discharge

Data type

text

Alias
UMLS CUI [1,1]
C1533716
UMLS CUI [1,2]
C0022864
UMLS CUI [1,3]
C0011209
UMLS CUI [1,4]
C0030685
DRUG EXPOSURES DURING PREGNANCY
Description

DRUG EXPOSURES DURING PREGNANCY

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

Drug Name

Data type

text

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

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Total Daily Dose
Description

Total Daily Dose

Data type

text

Alias
UMLS CUI [1]
C2348070
Units
Description

Units

Data type

text

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

Started Pre-Study

Data type

boolean

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

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Description

Reason for Medication

Data type

text

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

REPORTING INVESTIGATOR INFORMATION

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

Name

Data type

text

Alias
UMLS CUI [1]
C0008961
Title
Description

Title

Data type

text

Alias
UMLS CUI [1]
C3888414
Speciality
Description

Speciality

Data type

text

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

Address

Data type

text

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

City

Data type

text

Alias
UMLS CUI [1]
C0008848
Country
Description

Country

Data type

text

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

Zip Code

Data type

integer

Alias
UMLS CUI [1]
C0421454
Telephone No
Description

Telephone No

Data type

integer

Alias
UMLS CUI [1]
C1515258
Fax No
Description

Fax No

Data type

integer

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

Investigator signature

Data type

text

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

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008

Similar models

Pregnancy Follow- Up Form- Current Pregnancy Information Week 36

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PREGNANCY FOLLOW-UP FORM
C1522577 (UMLS CUI-1)
C0032961 (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])
Item
PREGNANCY STATUS
text
C0552579 (UMLS CUI [1])
Code List
PREGNANCY STATUS
CL Item
Stillbirth (Stillbirth)
CL Item
Foetal death (Foetal death)
CL Item
Method used for delivery, specify (Method used for delivery, specify)
delivery method
Item
Method used for delivery, specify
text
C0565867 (UMLS CUI [1])
Item
Early termination
text
C0156543 (UMLS CUI [1])
Code List
Early termination
CL Item
Spontaneous abortion (Spontaneous abortion)
C0000786 (UMLS CUI-1)
CL Item
Elective abortion (Elective abortion)
C0269439 (UMLS CUI-1)
CL Item
Other, specify (Other, specify)
Other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
Item
FOETAL/NEONATAL STATUS
text
C3533197 (UMLS CUI [1])
Code List
FOETAL/NEONATAL STATUS
CL Item
Normal (Normal)
CL Item
Birth defect (i.e., structural/chromosomal disorder) Complete Serious Adverse Event pages (Birth defect (i.e., structural/chromosomal disorder) Complete Serious Adverse Event pages)
CL Item
Other disorder (e.g., non-structural, premature birth, intrauterine death/stillbirth) (Other disorder (e.g., non-structural, premature birth, intrauterine death/stillbirth))
birth defect
Item
If birth defects are diagnosed, is the origin of the defect known?
boolean
C0000768 (UMLS CUI [1])
birth defect
Item
If Yes, specify
text
C0000768 (UMLS CUI [1])
Item Group
INFANT INFORMATION
C3840300 (UMLS CUI-1)
Date of birth
Item
Date of birth/miscarriage/termination
date
C0421451 (UMLS CUI [1,1])
C0000814 (UMLS CUI [1,2])
Gestational weeks at birth miscarriage
Item
Gestational weeks at birth/miscarriage/termination
integer
C2011191 (UMLS CUI [1,1])
C0000814 (UMLS CUI [1,2])
Item
Infant’s sex
text
C0079399 (UMLS CUI [1])
Code List
Infant’s sex
CL Item
Male (Male)
CL Item
Female (Female)
CL Item
Unknown (Unknown)
Length
Item
Length
float
C1444754 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Apgar score
Item
Apgar score (0 - 10) First assessment
integer
C0003533 (UMLS CUI [1])
Apgar score
Item
Apgar score (0 - 10) Second assessment
integer
C0003533 (UMLS CUI [1])
Item Group
PREGNANCY INFORMATION
C0032961 (UMLS CUI-1)
Information labour delivery discharge
Item
ADDITIONAL DETAILS (Provide additional details on current labour/delivery/discharge notes etc.)
text
C1533716 (UMLS CUI [1,1])
C0022864 (UMLS CUI [1,2])
C0011209 (UMLS CUI [1,3])
C0030685 (UMLS CUI [1,4])
Item Group
DRUG EXPOSURES DURING PREGNANCY
C0743284 (UMLS CUI-1)
C0032961 (UMLS CUI-2)
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])
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial