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Fehler:
ID
23862
Beschreibung
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.
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Versionen (1)
- 15.07.17 15.07.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
15. Juli 2017
DOI
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Creative Commons BY-NC 3.0
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Pregnancy Follow- Up Form- Current Pregnancy Information Week 36 Mepolizumab HES NCT00086658
Pregnancy Follow- Up Form- Current Pregnancy Information Week 36
- StudyEvent: ODM
Ähnliche Modelle
Pregnancy Follow- Up Form- Current Pregnancy Information Week 36
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0449788 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,2])
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])
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])
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])
Date of birth
Item
Date of birth/miscarriage/termination
date
C0421451 (UMLS CUI [1,1])
C0000814 (UMLS CUI [1,2])
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])
C0000814 (UMLS CUI [1,2])
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])
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])
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)
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])
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])
C0013227 (UMLS CUI [1,2])
Item Group
REPORTING INVESTIGATOR INFORMATION
C1955348 (UMLS CUI-1)
C0008961 (UMLS CUI-2)
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])
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])