Informatie:
Fout:
ID
41625
Beschrijving
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2
Trefwoorden
Versies (2)
- 25-11-20 25-11-20 -
- 29-11-20 29-11-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
29 november 2020
DOI
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Licentie
Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692
Pregnancy Information
- StudyEvent: ODM
Similar models
Pregnancy Information
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Subject
Item
Subject
text
C2348585 (UMLS CUI [1])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Doc#
Item
Doc#
integer
C1301746 (UMLS CUI [1])
Is Page Blank?
Item
Is Page Blank?
boolean
C1704732 (UMLS CUI [1,1])
C0750479 (UMLS CUI [1,2])
C0750479 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demography and Medical History (Pregnancy Notification Form)
C0011298 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
C0262926 (UMLS CUI-2)
C0032961 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
Subject ID Number
Item
Subject ID Number
text
C2348585 (UMLS CUI [1])
Race
Item
Race
text
C0034510 (UMLS CUI [1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Weight (kg)
Item
Weight (kg)
float
C0005910 (UMLS CUI [1])
Weight (pounds)
Item
Weight (pounds)
float
C0005910 (UMLS CUI [1])
Height (cm)
Item
Height (cm)
integer
C0005890 (UMLS CUI [1])
Height (inches)
Item
Height (inches)
integer
C0005890 (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])
Specify method of contraception
Item
Specify method of contraception
text
C0700589 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Normal (includes use of fertility drugs) (1)
CL Item
IVF (in vitro fertilization) (2)
Relevant laboratory tests and procedures:
Item
Relevant laboratory tests and procedures:
text
C0022885 (UMLS CUI [1])
Known allergies
Item
Known allergies
boolean
C0020517 (UMLS CUI [1])
Specify allergies
Item
Specify allergies
text
C0020517 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Alcohol intake
Item
Alcohol intake
boolean
C0001948 (UMLS CUI [1])
Specify alcohol intake
Item
Specify alcohol intake
text
C0001948 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Other significant prior or co-existent medical conditions or history
Item
Other significant prior or co-existent medical conditions or history
boolean
C0012634 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Specify other significant prior or co-existent medical conditions or history
Item
Specify other significant prior or co-existent medical conditions or history
text
C0012634 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3])
Item Group
Pregnancy Information (Pregnancy Notification Form)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C0032961 (UMLS CUI-4)
C1533716 (UMLS CUI-5)
C1533716 (UMLS CUI-2)
C0032961 (UMLS CUI-4)
C1533716 (UMLS CUI-5)
Start date of last menstrual period
Item
Start date of last menstrual period
date
C0425932 (UMLS CUI [1])
Date of positive pregnancy test:
Item
Date of positive pregnancy test:
date
C0240802 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Date of last negative pregnancy test:
Item
Date of last negative pregnancy test:
date
C0427780 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Was pregnancy terminated?
Item
Was pregnancy terminated?
boolean
C0032961 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,2])
Date of pregnancy termination
Item
Date of pregnancy termination
date
C0032961 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
If Yes, clarify if elective or spontaneous termination?
integer
C0444930 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0439608 (UMLS CUI [1,3])
C0444930 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0205359 (UMLS CUI [2,3])
C0032961 (UMLS CUI [1,2])
C0439608 (UMLS CUI [1,3])
C0444930 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0205359 (UMLS CUI [2,3])
Code List
If Yes, clarify if elective or spontaneous termination?
CL Item
Elective (1)
CL Item
Spontaneous (2)
Date of expected delivery:
Item
Date of expected delivery:
date
C1287845 (UMLS CUI [1])
Number of previous pregnancies: (If none, enter a zero)
Item
Number of previous pregnancies: (If none, enter a zero)
integer
C0422807 (UMLS CUI [1])
Number of live births: (If none, enter a zero)
Item
Number of live births: (If none, enter a zero)
integer
C2114488 (UMLS CUI [1])
Has subject experienced complications during this or previous pregnancies?
Item
Has subject experienced complications during this or previous pregnancies?
boolean
C0009566 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,2])
Specify complications during pregnancy
Item
Specify complications during pregnancy
text
C0009566 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0032961 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Specify congenital abnormality
Item
Specify congenital abnormality
text
C0000768 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item Group
Demography and Medical History (Pregnancy Outcome Form)
C0011298 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0032972 (UMLS CUI-4)
C0262926 (UMLS CUI-2)
C0032972 (UMLS CUI-4)
Subject ID Number
Item
Subject ID Number
text
C2348585 (UMLS CUI [1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Weight (kg)
Item
Weight (kg)
float
C0005910 (UMLS CUI [1])
Weight (pounds)
Item
Weight (pounds)
float
C0005910 (UMLS CUI [1])
Height (cm)
Item
Height (cm)
integer
C0005890 (UMLS CUI [1])
Height (inches)
Item
Height (inches)
integer
C0005890 (UMLS CUI [1])
Race
Item
Race
text
C0034510 (UMLS CUI [1])
Item Group
Child Information (Pregnancy Outcome Form)
C0008059 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C0032972 (UMLS CUI-3)
C1533716 (UMLS CUI-2)
C0032972 (UMLS CUI-3)
Baby #
Item
Baby #
integer
C0021270 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
CL Item
Male (M)
CL Item
Female (F)
Height (cm)
Item
Height (cm)
integer
C0005890 (UMLS CUI [1])
Height (inches)
Item
Height (inches)
integer
C0005890 (UMLS CUI [1])
Weight (kg)
Item
Weight (kg)
float
C0005910 (UMLS CUI [1])
Weight (Ibs/oz)
Item
Weight (Ibs/oz)
float
C0005910 (UMLS CUI [1])
Apgar score 1 min
Item
Apgar score 1 min
integer
C0003533 (UMLS CUI [1])
Apgar score 5 min
Item
Apgar score 5 min
integer
C0003533 (UMLS CUI [1])
CL Item
Spontaneous abortion (1)
CL Item
Elective abortion (2)
CL Item
Normal (3)
CL Item
Abnormal baby (specify below) (4)
CL Item
Congenital abnormality (specify below) (5)
CL Item
Stillborn (specify below) (6)
CL Item
Died at birth (specify below) (7)
Date of abortion
Item
Date of abortion
date
C0269439 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0000786 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C0000786 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Specify abnormal baby
Item
Specify abnormal baby
text
C0021270 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Specify stillborn
Item
Specify stillborn
text
C0595939 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Specify died at birth
Item
Specify died at birth
text
C3841004 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Date congenital abnormality identified/diagnosed:
Item
Date congenital abnormality identified/diagnosed:
date
C0000768 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
Item Group
Pregnancy Outcome Information (Pregnancy Outcome Form)
C0032972 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1533716 (UMLS CUI-2)
Date of delivery
Item
Date of delivery
date
C2053594 (UMLS CUI [1])
Length of gestation
Item
Length of gestation
integer
C0460089 (UMLS CUI [1])
Item
Method of delivery (select one):
integer
C2825496 (UMLS CUI [1])
CL Item
Vaginal (1)
CL Item
Cesarean section (2)
Number of births as a result of this pregnancy:
Item
Number of births as a result of this pregnancy:
integer
C3172256 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032961 (UMLS CUI [2])
Comments:
Item
Comments:
text
C0947611 (UMLS CUI [1])