ID

32516

Beskrivning

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

Nyckelord

Versioner (3)
  1. 2018-10-05 2018-10-05 -
  2. 2018-11-06 2018-11-06 -
  3. 2018-11-06 2018-11-06 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 november 2018

DOI

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

Engelsk

Day 7

1 Formulär  
  1. StudyEvent: ODM
    1. Day 7
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beskrivning

Date in time

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Blood Pressure (sitting) - Systolic
Beskrivning

Systolic pressure

Datatyp

integer

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

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (sitting)
Beskrivning

Heart rate

Datatyp

text

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Capillary Blood Glucose
Beskrivning

Capillary Blood Glucose

Alias
UMLS CUI-1
C0457578
Date
Beskrivning

Capillary Blood Glucose measurement; Date in time

Datatyp

date

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

Capillary Blood Glucose measurement; relative time

Datatyp

text

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

Capillary Blood Glucose measurement; Time

Datatyp

time

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

Capillary Blood Glucose measurement; Result

Datatyp

float

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

Capillary Blood Glucose measurement; Unit of measure

Datatyp

text

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C1519795
Anti-Diabetic Agent Tolerability Scale (ADATS)
Beskrivning

Anti-Diabetic Agent Tolerability Scale (ADATS)

Alias
UMLS CUI-1
C0935929
UMLS CUI-2
C3274448
Current Date
Beskrivning

Antidiabetics; Tolerability Study;Date in Time

Datatyp

date

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C3274448
UMLS CUI [1,3]
C0011008
Has the subject reported any AEs/SAEs or Hypoglycaemic Events during the past two days?
Beskrivning

Adverse event; Serious Adverse Event; Hypoglycaemic episode

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C1519255
UMLS CUI [3]
C0745153
How many AEs has the subject reported during the past two days?
Beskrivning

Adverse event; Quantity

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1265611
Adverse events
Beskrivning

Adverse events

Alias
UMLS CUI-1
C0877248
Adverse Event
Beskrivning

Adverse Event

Datatyp

text

Alias
UMLS CUI [1]
C0877248
AE page number
Beskrivning

Adverse event; Page, Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704732
UMLS CUI [1,3]
C0237753
AE row number
Beskrivning

Adverse event; row (table), number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1552840
UMLS CUI [1,3]
C0237753
Anti-Diabetic Agent Tolerability Scale (ADATS) - Worksheet
Beskrivning

Anti-Diabetic Agent Tolerability Scale (ADATS) - Worksheet

Alias
UMLS CUI-1
C0935929
UMLS CUI-2
C3274448
UMLS CUI-3
C2349155
During the past 2 days, how bothersome has your (most bothersome AE) been to you?
Beskrivning

Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4489383
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C4489382
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C4489381
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C4489380
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C4489379
During the past 2 days, how bothersome has your (second most bothersome AE) been to you?
Beskrivning

Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4489383
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C4489382
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C4489381
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C4489380
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C4489379
During the past 2 days, how bothersome has your (third most bothersome AE) been to you?
Beskrivning

Adverse event, Not at all bothersome; Adverse event, Slightly bothersome; Adverse event, Moderately bothersome; Adverse event, Quite a bit bothersome; Adverse event, Extremely bothersome

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4489383
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C4489382
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C4489381
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C4489380
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C4489379
During the past 2 days, overall, how much were you bothered by side effects of the study medications?
Beskrivning

Experimental drug; Adverse reaction to drug; Impaired

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0041755
UMLS CUI [1,3]
C0221099
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Similar models

Day 7

1 Formulär
  1. StudyEvent: ODM
    1. Day 7
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
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
Anti-Diabetic Agent Tolerability Scale (ADATS)
C0935929 (UMLS CUI-1)
C3274448 (UMLS CUI-2)
Antidiabetics; Tolerability Study;Date in Time
Item
Current Date
date
C0935929 (UMLS CUI [1,1])
C3274448 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Adverse event; Serious Adverse Event; Hypoglycaemic episode
Item
Has the subject reported any AEs/SAEs or Hypoglycaemic Events during the past two days?
boolean
C0877248 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C0745153 (UMLS CUI [3])
Adverse event; Quantity
Item
How many AEs has the subject reported during the past two days?
integer
C0877248 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Item Group
Adverse events
C0877248 (UMLS CUI-1)
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Adverse event; Page, Number
Item
AE page number
integer
C0877248 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Adverse event; row (table), number
Item
AE row number
integer
C0877248 (UMLS CUI [1,1])
C1552840 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item Group
Anti-Diabetic Agent Tolerability Scale (ADATS) - Worksheet
C0935929 (UMLS CUI-1)
C3274448 (UMLS CUI-2)
C2349155 (UMLS CUI-3)
Item
During the past 2 days, how bothersome has your (most bothersome AE) been to you?
text
C0877248 (UMLS CUI [1,1])
C4489383 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C4489382 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C4489381 (UMLS CUI [3,2])
C0877248 (UMLS CUI [4,1])
C4489380 (UMLS CUI [4,2])
C0877248 (UMLS CUI [5,1])
C4489379 (UMLS CUI [5,2])
undefined item
Code List
During the past 2 days, how bothersome has your (most bothersome AE) been to you?
CL Item
Not at all bothersome (0)
CL Item
A little bit bothersome (1)
CL Item
Moderately bothersome (2)
CL Item
Quite bothersome (3)
CL Item
Extremely bothersome (4)
Item
During the past 2 days, how bothersome has your (second most bothersome AE) been to you?
text
C0877248 (UMLS CUI [1,1])
C4489383 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C4489382 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C4489381 (UMLS CUI [3,2])
C0877248 (UMLS CUI [4,1])
C4489380 (UMLS CUI [4,2])
C0877248 (UMLS CUI [5,1])
C4489379 (UMLS CUI [5,2])
undefined item
Code List
During the past 2 days, how bothersome has your (second most bothersome AE) been to you?
CL Item
Not at all bothersome (0)
CL Item
A little bit bothersome (1)
CL Item
Moderately bothersome (2)
CL Item
Quite bothersome (3)
CL Item
Extremely bothersome (4)
Item
During the past 2 days, how bothersome has your (third most bothersome AE) been to you?
text
C0877248 (UMLS CUI [1,1])
C4489383 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C4489382 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C4489381 (UMLS CUI [3,2])
C0877248 (UMLS CUI [4,1])
C4489380 (UMLS CUI [4,2])
C0877248 (UMLS CUI [5,1])
C4489379 (UMLS CUI [5,2])
undefined item
Code List
During the past 2 days, how bothersome has your (third most bothersome AE) been to you?
CL Item
Not at all bothersome (0)
CL Item
A little bit bothersome (1)
CL Item
Moderately bothersome (2)
CL Item
Quite bothersome (3)
CL Item
Extremely bothersome (4)
Item
During the past 2 days, overall, how much were you bothered by side effects of the study medications?
text
C0304229 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
undefined item
Code List
During the past 2 days, overall, how much were you bothered by side effects of the study medications?
CL Item
Not at all bothersome (0)
CL Item
A little bothered  (1)
CL Item
Moderately bothered  (2)
CL Item
Quite bothered  (3)
CL Item
Extremely bothered (4)
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