ID

32523

Beschrijving

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Trefwoorden

Versies (2)
  1. 01-10-18 01-10-18 -
  2. 06-11-18 06-11-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

6 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

Engels

Day 28

1 Formulieren  
  1. StudyEvent: ODM
    1. Day 28
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschrijving

Date in time

Datatype

date

Alias
UMLS CUI [1]
C0011008
Weight
Beschrijving

Body Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood Pressure (sitting) - Systolic
Beschrijving

Systolic Pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure (sitting) - Diastolic
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (sitting)
Beschrijving

Heart rate

Datatype

text

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Immunogenicity testing, Blood
Beschrijving

Immunogenicity testing, Blood

Alias
UMLS CUI-1
C4054739
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Immunogenicity Study; Blood; relative time

Datatype

text

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
Date Sample Taken
Beschrijving

Immunogenicity Study; Blood; Sampling; Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Beschrijving

Immunogenicity Study; Blood; Sampling; Time

Datatype

time

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
Sample Number
Beschrijving

Immunogenicity Study; Blood; Sample identification number

Datatype

integer

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
Pharmacokinetics; Blood
Beschrijving

Pharmacokinetics; Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Pharmacokinetic aspects; Blood; relative time

Datatype

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
Date Sample Taken
Beschrijving

Pharmacokinetic aspects; Blood; Sampling; Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Beschrijving

Pharmacokinetic aspects; Blood; Sampling; Time

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
Sample Number
Beschrijving

Pharmacokinetic aspects; Blood; Sample identification number

Datatype

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
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Similar models

Day 28

1 Formulieren
  1. StudyEvent: ODM
    1. Day 28
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date in time
Item
Date
date
C0011008 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Pressure
Item
Blood Pressure (sitting) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure (sitting) - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate (sitting)
text
C0018810 (UMLS CUI [1])
Item Group
Immunogenicity testing, Blood
C4054739 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Immunogenicity Study; Blood; relative time
Item
Planned Relative Time
text
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Immunogenicity Study; Blood; Sampling; Date in time
Item
Date Sample Taken
date
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Immunogenicity Study; Blood; Sampling; Time
Item
Actual Time
time
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Immunogenicity Study; Blood; Sample identification number
Item
Sample Number
integer
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Item Group
Pharmacokinetics; Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Pharmacokinetic aspects; Blood; relative time
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; Sampling; Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacokinetic aspects; Blood; Sampling; Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; Sample identification number
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
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