ID

31966

Beschreibung

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

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  1. 09.10.18 09.10.18 -
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GlaxoSmithKline

Hochgeladen am

9. Oktober 2018

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Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

Englisch

Final Follow-Up

1 Formulare  
  1. StudyEvent: ODM
    1. Final Follow-Up
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start Date of ECG
Beschreibung

12 lead ECG; Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Ventricular Rate
Beschreibung

12 lead ECG; Ventricular Rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
bpm
PR Interval
Beschreibung

12 lead ECG; PR Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Beschreibung

12 lead ECG; QRS complex Duration

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Beschreibung

12 lead ECG; QT interval finding

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Beschreibung

12 lead ECG; QTc Interval

Datentyp

integer

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Beschreibung

12 lead ECG; result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C1274040
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschreibung

Date in time

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Weight
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood Pressure (sitting), Systolic
Beschreibung

Systolic Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure (sitting), Diastolic
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (sitting)
Beschreibung

Heart rate

Datentyp

text

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Has a physical examination been performed on the subject?
Beschreibung

Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0031809
Was the physical examination
Beschreibung

Physical Examination, Test Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0456984
Electronically transferred laboratory data - Clinical Chemistry
Beschreibung

Electronically transferred laboratory data - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Date Sample Taken
Beschreibung

Clinical Chemistry; Sampling; Date in time

Datentyp

date

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

Clinical Chemistry; Time

Datentyp

time

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

Electronically transferred laboratory data - Haematology

Alias
UMLS CUI-1
C0474523
Date Sample Taken
Beschreibung

Hematology finding; Sampling; Date in time

Datentyp

date

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

Hematology finding; Time

Datentyp

time

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

Electronically transferred laboratory data - Urinalysis

Alias
UMLS CUI-1
C0042014
Date Sample Taken
Beschreibung

Urinalysis; Sampling; Date in time

Datentyp

date

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

Urinalysis; Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
Electronically transferred Laboratory Data - Fructosamine
Beschreibung

Electronically transferred Laboratory Data - Fructosamine

Alias
UMLS CUI-1
C0202025
Date Sample Taken
Beschreibung

Fructosamine measurement; Sampling, Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0202025
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Beschreibung

Fructosamine measurement; Sampling; Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0202025
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
Immunogenicity Testing; Blood
Beschreibung

Immunogenicity Testing; Blood

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

Immunogenicity Study; Blood; relative time

Datentyp

text

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

Pharmacokinetic aspects; Blood; Sampling; Date in time

Datentyp

date

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

Pharmacokinetic aspects; Blood; Sampling; Time

Datentyp

time

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

Pharmacokinetic aspects; Blood; Sample identification number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
Pharmacokinetic aspects; Blood
Beschreibung

Pharmacokinetic aspects; Blood

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031328
Planned Relative Time
Beschreibung

Pharmacokinetic aspects; Blood; relative time

Datentyp

text

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

Pharmacokinetic aspects; Blood; Sampling; Date in time

Datentyp

date

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

Pharmacokinetic aspects; Blood; Sampling; Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Sample Number
Beschreibung

Pharmacokinetic aspects; Blood; Sample identification number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
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Ähnliche Modelle

Final Follow-Up

1 Formulare
  1. StudyEvent: ODM
    1. Final Follow-Up
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
12 lead ECG; Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
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
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
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination
Item
Has a physical examination been performed on the subject?
boolean
C0031809 (UMLS CUI [1])
Item
Was the physical examination
text
C0031809 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Physical Examination, Test Result
Code List
Was the physical examination
CL Item
Normal (Normal)
CL Item
Abnormal (give details) (Abnormal (give details))
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])
Item Group
Electronically transferred Laboratory Data - Fructosamine
C0202025 (UMLS CUI-1)
Fructosamine measurement; Sampling, Date
Item
Date Sample Taken
date
C0202025 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Fructosamine measurement; Sampling; Time
Item
Actual Time
time
C0202025 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Immunogenicity Testing; Blood
C4054739 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
text
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Immunogenicity Study; Blood; relative time
Code List
Planned Relative Time
CL Item
Final Follow-Up (Final Follow-Up)
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])
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; Sample identification number
Code List
Sample Number
CL Item
505 (1)
Item Group
Pharmacokinetic aspects; Blood
C0005834 (UMLS CUI-1)
C0031328 (UMLS CUI-2)
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; relative time
Code List
Planned Relative Time
CL Item
Any time (Any time)
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])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; Sample identification number
Code List
Sample Number
CL Item
121 (1)
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