ID

32514

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

Stichworte

Versionen (3)
  1. 05.10.18 05.10.18 -
  2. 06.11.18 06.11.18 -
  3. 06.11.18 06.11.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

6. November 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

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

Englisch

Day 1

1 Formulare  
  1. StudyEvent: ODM
    1. Day 1
Randomisation Number
Beschreibung

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number
Beschreibung

undefined item

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Beschreibung

Randomization; Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
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
48-hr Telemetry ECG
Beschreibung

48-hr Telemetry ECG

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0039451
Start Date of ECG
Beschreibung

Electrocardiogram; Telemetry; Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0039451
UMLS CUI [1,3]
C0808070
Start Time of ECG
Beschreibung

Electrocardiogram; Telemetry; Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0039451
UMLS CUI [1,3]
C1301880
End Date of ECG
Beschreibung

Electrocardiogram; Telemetry; End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0039451
UMLS CUI [1,3]
C0806020
End time of ECG
Beschreibung

Electrocardiogram; Telemetry; End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0039451
UMLS CUI [1,3]
C1522314
Result of the ECG
Beschreibung

Electrocardiogram; Telemetry; Result

Datentyp

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0039451
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
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
Capillary Blood Glucose
Beschreibung

Capillary Blood Glucose

Alias
UMLS CUI-1
C0457578
Date
Beschreibung

Capillary Blood Glucose measurement; Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C0011008
Planned relative time (e.g. prior to breakfast)
Beschreibung

Capillary Blood Glucose measurement; relative time

Datentyp

text

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C0439564
Time
Beschreibung

Capillary Blood Glucose measurement; Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C0040223
Result
Beschreibung

Capillary Blood Glucose measurement; Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C1274040
Unit
Beschreibung

Capillary Blood Glucose measurement; Unit of measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C1519795
Pharmacokinetics, Blood
Beschreibung

Pharmacokinetics, Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C1299222
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]
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
Investigational Product
Beschreibung

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned Timepoint (e.g. Day 1)
Beschreibung

Experimental Drug; Timepoint, Planned

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C1301732
Date of Injection
Beschreibung

Experimental Drug; Injection procedure; Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0011008
Time of Injection
Beschreibung

Experimental Drug; Injection procedure; Date in time

Datentyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0040223
Dose
Beschreibung

Experimental Drug; Medication dose

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3174092
mg
Treatment Confirmation
Beschreibung

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschreibung

Therapeutic procedure; Confirmation

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750484
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Day 1

1 Formulare
  1. StudyEvent: ODM
    1. Day 1
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
undefined item
Item
Record randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Randomization; Date in time
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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)
Item Group
48-hr Telemetry ECG
C1623258 (UMLS CUI-1)
C0039451 (UMLS CUI-2)
Electrocardiogram; Telemetry; Start Date
Item
Start Date of ECG
date
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Electrocardiogram; Telemetry; Start Time
Item
Start Time of ECG
time
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Electrocardiogram; Telemetry; End Date
Item
End Date of ECG
date
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Electrocardiogram; Telemetry; End Time
Item
End time of ECG
time
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Result of the ECG
text
C1623258 (UMLS CUI [1,1])
C0039451 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Electrocardiogram; Telemetry; 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])
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
Capillary Blood Glucose
C0457578 (UMLS CUI-1)
Capillary Blood Glucose measurement; Date in time
Item
Date
date
C0457578 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Capillary Blood Glucose measurement; relative time
Item
Planned relative time (e.g. prior to breakfast)
text
C0457578 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Capillary Blood Glucose measurement; Time
Item
Time
time
C0457578 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Capillary Blood Glucose measurement; Result
Item
Result
float
C0457578 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Unit
text
C0457578 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Capillary Blood Glucose measurement; Unit of measure
Code List
Unit
CL Item
mmol/L (mmol/L)
CL Item
mg/dL (mg/dL)
Item Group
Pharmacokinetics, Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C1299222 (UMLS CUI-3)
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
Predose (1)
CL Item
3.5 hr (2)
CL Item
8.5 hr (3)
CL Item
18.5 hr (4)
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
101 (1)
CL Item
102 (2)
CL Item
103 (3)
CL Item
104 (4)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Experimental Drug; Timepoint, Planned
Item
Planned Timepoint (e.g. Day 1)
text
C0304229 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Experimental Drug; Injection procedure; Date in time
Item
Date of Injection
date
C0304229 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental Drug; Injection procedure; Date in time
Item
Time of Injection
time
C0304229 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Experimental Drug; Medication dose
Item
Dose
integer
C0304229 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Therapeutic procedure; Confirmation
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
Yes (Yes)
CL Item
No (give reasons) (No (give reasons))
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video