ID

32517

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 (3)
  1. 01-10-18 01-10-18 -
  2. 01-10-18 01-10-18 - Julian Varghese
  3. 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 -2

1 Formulieren  
  1. StudyEvent: ODM
    1. Day -2
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschrijving

Date in time

Datatype

date

Alias
UMLS CUI [1]
C0011008
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
Urine Drug Screen
Beschrijving

Urine Drug Screen

Alias
UMLS CUI-1
C0202274
Date sample taken
Beschrijving

Urine drug screening; Sampling; Date in Time

Datatype

date

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Cocaine
Beschrijving

Urine drug screening; Cocaine

Datatype

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0009170
Amphetamines
Beschrijving

Urine drug screening; Amphetamines

Datatype

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0002667
PCP
Beschrijving

Urine drug screening; Phenylcyclidine

Datatype

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0031381
Benzodiazepines
Beschrijving

Urine drug screening; Benzodiazepines

Datatype

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0005064
Cannabinoids
Beschrijving

Urine drug screening; Cannabinoids

Datatype

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0006864
Opiates
Beschrijving

Urine drug screening; Opiates

Datatype

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0376196
Barbiturates
Beschrijving

Urine drug screening; Barbiturates

Datatype

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0004745
Cotinine
Beschrijving

Urine drug screening; Cotinine

Datatype

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0202363
Alcohol urine or breath test
Beschrijving

Alcohol urine or breath test

Alias
UMLS CUI-1
C0202304
UMLS CUI-2
C0042036
UMLS CUI-3
C0202306
Date sample taken
Beschrijving

Ethanol measurement; Sampling; Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Result
Beschrijving

Ethanol measurement; Result

Datatype

text

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C1274040
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Similar models

Day -2

1 Formulieren
  1. StudyEvent: ODM
    1. Day -2
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])
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
Urine Drug Screen
C0202274 (UMLS CUI-1)
Urine drug screening; Sampling; Date in Time
Item
Date sample taken
date
C0202274 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Cocaine
text
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Urine drug screening; Cocaine
Code List
Cocaine
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Amphetamines
text
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Urine drug screening; Cocaine
Code List
Amphetamines
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
PCP
text
C0202274 (UMLS CUI [1,1])
C0031381 (UMLS CUI [1,2])
Urine drug screening; Cocaine
Code List
PCP
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Benzodiazepines
text
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Urine drug screening; Cocaine
Code List
Benzodiazepines
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Cannabinoids
text
C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Urine drug screening; Cannabinoids
Code List
Cannabinoids
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Opiates
text
C0202274 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
Urine drug screening; Cannabinoids
Code List
Opiates
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Barbiturates
text
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Urine drug screening; Cannabinoids
Code List
Barbiturates
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Cotinine
text
C0202274 (UMLS CUI [1,1])
C0202363 (UMLS CUI [1,2])
Urine drug screening; Cannabinoids
Code List
Cotinine
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Alcohol urine or breath test
C0202304 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
C0202306 (UMLS CUI-3)
Ethanol measurement; Sampling; Date in time
Item
Date sample taken
date
C0202304 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Result
text
C0202304 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Ethanol measurement; Result
Code List
Result
CL Item
Positive (Positive)
CL Item
Negative (Negative)
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