ID

32516

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

Keywords

Versions (3)
  1. 10/5/18 10/5/18 -
  2. 11/6/18 11/6/18 -
  3. 11/6/18 11/6/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

English

Day 7

1 forms  
  1. StudyEvent: ODM
    1. Day 7
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Description

Date in time

Data type

date

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

Systolic pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure (sitting) - Diastolic
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (sitting)
Description

Heart rate

Data type

text

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Capillary Blood Glucose
Description

Capillary Blood Glucose

Alias
UMLS CUI-1
C0457578
Date
Description

Capillary Blood Glucose measurement; Date in time

Data type

date

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

Capillary Blood Glucose measurement; relative time

Data type

text

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

Capillary Blood Glucose measurement; Time

Data type

time

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

Capillary Blood Glucose measurement; Result

Data type

float

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

Capillary Blood Glucose measurement; Unit of measure

Data type

text

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

Anti-Diabetic Agent Tolerability Scale (ADATS)

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

Antidiabetics; Tolerability Study;Date in Time

Data type

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?
Description

Adverse event; Serious Adverse Event; Hypoglycaemic episode

Data type

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?
Description

Adverse event; Quantity

Data type

integer

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

Adverse events

Alias
UMLS CUI-1
C0877248
Adverse Event
Description

Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0877248
AE page number
Description

Adverse event; Page, Number

Data type

integer

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

Adverse event; row (table), number

Data type

integer

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

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?
Description

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

Data type

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?
Description

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

Data type

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?
Description

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

Data type

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?
Description

Experimental drug; Adverse reaction to drug; Impaired

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0041755
UMLS CUI [1,3]
C0221099
Back to the top of the page

Similar models

Day 7

1 forms
  1. StudyEvent: ODM
    1. Day 7
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial