ID

32519

Description

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

Mots-clés

Versions (2)
  1. 01/10/2018 01/10/2018 -
  2. 06/11/2018 06/11/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

6 novembre 2018

DOI

Pour une demande vous connecter.

Licence

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

Anglais

Unscheduled

1 Formulaires  
  1. StudyEvent: ODM
    1. Unscheduled
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Description

Date in time

Type de données

date

Alias
UMLS CUI [1]
C0011008
Weight
Description

Body Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood Pressure (sitting) - Systolic
Description

Systolic Pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure (sitting) - Diastolic
Description

Diastolic blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (sitting)
Description

Heart rate

Type de données

text

Unités de mesure
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12 lead ECG
Description

12 lead ECG

Alias
UMLS CUI-1
C0430456
Ventricular Rate
Description

12 lead ECG; Ventricular Rate

Type de données

integer

Unités de mesure
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
bpm
PR Interval
Description

12 lead ECG; PR Interval

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

12 lead ECG; QRS complex Duration

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

12 lead ECG; QT interval finding

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Description

12 lead ECG; QTc Interval

Type de données

integer

Unités de mesure
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Description

12 lead ECG; result

Type de données

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C1274040
Electronically transferred laboratory data - Clinical Chemistry
Description

Electronically transferred laboratory data - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Date Sample Taken
Description

Clinical Chemistry; Sampling; Date in time

Type de données

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Description

Clinical Chemistry; Time

Type de données

time

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0040223
Electronically transferred laboratory data - Haematology
Description

Electronically transferred laboratory data - Haematology

Alias
UMLS CUI-1
C0474523
Date Sample Taken
Description

Hematology finding; Sampling; Date in time

Type de données

date

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Description

Hematology finding; Time

Type de données

time

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0040223
Electronically transferred laboratory data - Urinalysis
Description

Electronically transferred laboratory data - Urinalysis

Alias
UMLS CUI-1
C0042014
Date Sample Taken
Description

Urinalysis; Sampling; Date in time

Type de données

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Description

Urinalysis; Time

Type de données

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
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Similar models

Unscheduled

1 Formulaires
  1. StudyEvent: ODM
    1. Unscheduled
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
12 lead ECG
C0430456 (UMLS CUI-1)
12 lead ECG; Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
12 lead ECG; PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG; QRS complex Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG; QT interval finding
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG; QTc Interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
12 lead ECG; result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant  (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
Item Group
Electronically transferred laboratory data - Clinical Chemistry
C0008000 (UMLS CUI-1)
Clinical Chemistry; Sampling; Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Clinical Chemistry; Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data - Haematology
C0474523 (UMLS CUI-1)
Hematology finding; Sampling; Date in time
Item
Date Sample Taken
date
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hematology finding; Time
Item
Actual Time
time
C0474523 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data - Urinalysis
C0042014 (UMLS CUI-1)
Urinalysis; Sampling; Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis; Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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