ID

41625

Beschreibung

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

Stichworte

Versionen (2)
  1. 25.11.20 25.11.20 -
  2. 29.11.20 29.11.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

29. November 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

Englisch

Pregnancy Information

1 Formulare  
  1. StudyEvent: ODM
    1. Pregnancy Information
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Subject
Beschreibung

Subject

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Status
Beschreibung

Status

Datentyp

text

Alias
UMLS CUI [1]
C0449438
Doc#
Beschreibung

Doc#

Datentyp

integer

Alias
UMLS CUI [1]
C1301746
Is Page Blank?
Beschreibung

Is Page Blank?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0750479
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Demography and Medical History (Pregnancy Notification Form)
Beschreibung

Demography and Medical History (Pregnancy Notification Form)

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C0262926
UMLS CUI-3
C0032961
UMLS CUI-4
C1533716
Subject ID Number
Beschreibung

Subject ID Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Race
Beschreibung

Race

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Age
Beschreibung

Age

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1]
C0001779
years
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Weight (kg)
Beschreibung

Weight (kg)

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight (pounds)
Beschreibung

Weight (pounds)

Datentyp

float

Maßeinheiten
  • pounds
Alias
UMLS CUI [1]
C0005910
pounds
Height (cm)
Beschreibung

Height (cm)

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Height (inches)
Beschreibung

Height (inches)

Datentyp

integer

Maßeinheiten
  • inches
Alias
UMLS CUI [1]
C0005890
inches
Was the mother using a method of contraception?
Beschreibung

Was the mother using a method of contraception?

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
Specify method of contraception
Beschreibung

Specify method of contraception

Datentyp

text

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C2348235
Type of conception, select one
Beschreibung

Type of conception, select one

Datentyp

integer

Alias
UMLS CUI [1]
C2598844
Relevant laboratory tests and procedures:
Beschreibung

(e.g. ultrasound, amniocentesis, chronic villi sampling, including dates of test and procedures)

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Known allergies
Beschreibung

Known allergies

Datentyp

boolean

Alias
UMLS CUI [1]
C0020517
Specify allergies
Beschreibung

Specify allergies

Datentyp

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2348235
Alcohol intake
Beschreibung

Alcohol intake

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
Specify alcohol intake
Beschreibung

Specify alcohol intake

Datentyp

text

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C2348235
Other significant prior or co-existent medical conditions or history
Beschreibung

Other significant prior or co-existent medical conditions or history

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0205394
Specify other significant prior or co-existent medical conditions or history
Beschreibung

Specify other significant prior or co-existent medical conditions or history

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C2348235
Pregnancy Information (Pregnancy Notification Form)
Beschreibung

Pregnancy Information (Pregnancy Notification Form)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
UMLS CUI-4
C0032961
UMLS CUI-5
C1533716
Start date of last menstrual period
Beschreibung

Start date of last menstrual period

Datentyp

date

Alias
UMLS CUI [1]
C0425932
Date of positive pregnancy test:
Beschreibung

Date of positive pregnancy test:

Datentyp

date

Alias
UMLS CUI [1,1]
C0240802
UMLS CUI [1,2]
C0011008
Date of last negative pregnancy test:
Beschreibung

Date of last negative pregnancy test:

Datentyp

date

Alias
UMLS CUI [1,1]
C0427780
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
Was pregnancy terminated?
Beschreibung

Was pregnancy terminated?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0444930
Date of pregnancy termination
Beschreibung

Date of pregnancy termination

Datentyp

date

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0806020
If Yes, clarify if elective or spontaneous termination?
Beschreibung

If Yes, clarify if elective or spontaneous termination?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0444930
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0439608
UMLS CUI [2,1]
C0444930
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0205359
Date of expected delivery:
Beschreibung

Date of expected delivery:

Datentyp

date

Alias
UMLS CUI [1]
C1287845
Number of previous pregnancies: (If none, enter a zero)
Beschreibung

Number of previous pregnancies: (If none, enter a zero)

Datentyp

integer

Alias
UMLS CUI [1]
C0422807
Number of live births: (If none, enter a zero)
Beschreibung

Number of live births: (If none, enter a zero)

Datentyp

integer

Alias
UMLS CUI [1]
C2114488
Has subject experienced complications during this or previous pregnancies?
Beschreibung

Has subject experienced complications during this or previous pregnancies?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0032961
Specify complications during pregnancy
Beschreibung

Specify complications during pregnancy

Datentyp

text

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C2348235
Specify congenital abnormality
Beschreibung

Specify congenital abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C2348235
Demography and Medical History (Pregnancy Outcome Form)
Beschreibung

Demography and Medical History (Pregnancy Outcome Form)

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C0262926
UMLS CUI-4
C0032972
Subject ID Number
Beschreibung

Subject ID Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Age
Beschreibung

Age

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1]
C0001779
years
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Weight (kg)
Beschreibung

Weight (kg)

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight (pounds)
Beschreibung

Weight (pounds)

Datentyp

float

Maßeinheiten
  • pounds
Alias
UMLS CUI [1]
C0005910
pounds
Height (cm)
Beschreibung

Height (cm)

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Height (inches)
Beschreibung

Height (inches)

Datentyp

integer

Maßeinheiten
  • inches
Alias
UMLS CUI [1]
C0005890
inches
Race
Beschreibung

Race

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Child Information (Pregnancy Outcome Form)
Beschreibung

Child Information (Pregnancy Outcome Form)

Alias
UMLS CUI-1
C0008059
UMLS CUI-2
C1533716
UMLS CUI-3
C0032972
Baby #
Beschreibung

Baby #

Datentyp

integer

Alias
UMLS CUI [1,1]
C0021270
UMLS CUI [1,2]
C0237753
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Height (cm)
Beschreibung

Height (cm)

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Height (inches)
Beschreibung

Height (inches)

Datentyp

integer

Maßeinheiten
  • inches
Alias
UMLS CUI [1]
C0005890
inches
Weight (kg)
Beschreibung

Weight (kg)

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Weight (Ibs/oz)
Beschreibung

Weight (Ibs/oz)

Datentyp

float

Maßeinheiten
  • ibs/oz
Alias
UMLS CUI [1]
C0005910
ibs/oz
Apgar score 1 min
Beschreibung

Apgar score 1 min

Datentyp

integer

Alias
UMLS CUI [1]
C0003533
Apgar score 5 min
Beschreibung

Apgar score 5 min

Datentyp

integer

Alias
UMLS CUI [1]
C0003533
Outcome of pregnancy
Beschreibung

Outcome of pregnancy

Datentyp

integer

Alias
UMLS CUI [1]
C0032972
Date of abortion
Beschreibung

Date of abortion

Datentyp

date

Alias
UMLS CUI [1,1]
C0269439
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0000786
UMLS CUI [2,2]
C0011008
Specify abnormal baby
Beschreibung

Specify abnormal baby

Datentyp

text

Alias
UMLS CUI [1,1]
C0021270
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2348235
Specify stillborn
Beschreibung

Specify stillborn

Datentyp

text

Alias
UMLS CUI [1,1]
C0595939
UMLS CUI [1,2]
C2348235
Specify died at birth
Beschreibung

Specify died at birth

Datentyp

text

Alias
UMLS CUI [1,1]
C3841004
UMLS CUI [1,2]
C2348235
Date congenital abnormality identified/diagnosed:
Beschreibung

Date congenital abnormality identified/diagnosed:

Datentyp

date

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C2316983
Pregnancy Outcome Information (Pregnancy Outcome Form)
Beschreibung

Pregnancy Outcome Information (Pregnancy Outcome Form)

Alias
UMLS CUI-1
C0032972
UMLS CUI-2
C1533716
Date of delivery
Beschreibung

Date of delivery

Datentyp

date

Alias
UMLS CUI [1]
C2053594
Length of gestation
Beschreibung

Length of gestation

Datentyp

integer

Maßeinheiten
  • weeks
Alias
UMLS CUI [1]
C0460089
weeks
Method of delivery (select one):
Beschreibung

Method of delivery (select one):

Datentyp

integer

Alias
UMLS CUI [1]
C2825496
Number of births as a result of this pregnancy:
Beschreibung

(include live and stillbirth) (If none, enter a zero)

Datentyp

integer

Alias
UMLS CUI [1]
C3172256
UMLS CUI [2]
C0032961
Comments:
Beschreibung

Comments:

Datentyp

text

Alias
UMLS CUI [1]
C0947611
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Ähnliche Modelle

Pregnancy Information

1 Formulare
  1. StudyEvent: ODM
    1. Pregnancy Information
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
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])
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)
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])
Item
Type of conception, select one
integer
C2598844 (UMLS CUI [1])
Type of conception, select one
Code List
Type of conception, select one
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])
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])
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])
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])
Item Group
Pregnancy Information (Pregnancy Notification Form)
C0032961 (UMLS CUI-1)
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])
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])
Was pregnancy terminated?
Item
Was pregnancy terminated?
boolean
C0032961 (UMLS CUI [1,1])
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])
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])
If Yes, clarify if elective or spontaneous termination?
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])
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])
Specify congenital abnormality
Item
Specify congenital abnormality
text
C0000768 (UMLS CUI [1,1])
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)
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)
Baby #
Item
Baby #
integer
C0021270 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
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])
Item
Outcome of pregnancy
integer
C0032972 (UMLS CUI [1])
Outcome of pregnancy
Code List
Outcome of pregnancy
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])
Specify abnormal baby
Item
Specify abnormal baby
text
C0021270 (UMLS CUI [1,1])
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])
Specify died at birth
Item
Specify died at birth
text
C3841004 (UMLS CUI [1,1])
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])
Item Group
Pregnancy Outcome Information (Pregnancy Outcome Form)
C0032972 (UMLS CUI-1)
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])
Method of delivery (select one):
Code List
Method of delivery (select one):
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])
Comments:
Item
Comments:
text
C0947611 (UMLS CUI [1])
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