ID

31962

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 (1)
  1. 09/10/2018 09/10/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

9 octobre 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

Day 13

1 Formulaires  
  1. StudyEvent: ODM
    1. Day 13
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start Date of ECG
Description

12 lead ECG; Start Date

Type de données

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time
Description

12 lead ECG; Relative time

Type de données

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
Start Time of ECG
Description

12 lead ECG; Start Time

Type de données

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
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
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Description

Body Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Date
Description

Date in time

Type de données

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time
Description

Vital Signs; Relative Time

Type de données

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual Time
Description

Vital Signs Time

Type de données

time

Alias
UMLS CUI [1]
C2826762
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
Physical Examination
Description

Physical Examination

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

Physical Examination

Type de données

boolean

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

Physical Examination, Test Result

Type de données

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0456984
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
Electronically transferred Laboratory Data - Free Fatty Acids
Description

Electronically transferred Laboratory Data - Free Fatty Acids

Alias
UMLS CUI-1
C0373606
Date Sample Taken
Description

Free Fatty Acids measurement; Sampling; Date in time

Type de données

date

Alias
UMLS CUI [1,1]
C0373606
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Description

Free Fatty Acids measurement; Sampling; Time

Type de données

time

Alias
UMLS CUI [1,1]
C0373606
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
Electronically transferred Laboratory Data - Fructosamine
Description

Electronically transferred Laboratory Data - Fructosamine

Alias
UMLS CUI-1
C0202025
Date Sample Taken
Description

Fructosamine measurement; Sampling, Date

Type de données

date

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

Fructosamine measurement; Sampling; Time

Type de données

time

Alias
UMLS CUI [1,1]
C0202025
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
Capillary Blood Glucose
Description

Capillary Blood Glucose

Alias
UMLS CUI-1
C0457578
Date
Description

Capillary Blood Glucose measurement; Date in time

Type de données

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

Type de données

text

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

Capillary Blood Glucose measurement; Time

Type de données

time

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

Capillary Blood Glucose measurement; Result

Type de données

float

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

Capillary Blood Glucose measurement; Unit of measure

Type de données

text

Alias
UMLS CUI [1,1]
C0457578
UMLS CUI [1,2]
C1519795
Bioactivity Sampling; Blood
Description

Bioactivity Sampling; Blood

Alias
UMLS CUI-1
C0599112
UMLS CUI-2
C0005834
Planned Relative Time
Description

drug biological activity; Collection of blood specimen for laboratory procedure; relative time

Type de données

text

Alias
UMLS CUI [1,1]
C0599112
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0439564
Date Sample Taken
Description

drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Date in time

Type de données

date

Alias
UMLS CUI [1,1]
C0599112
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
Actual Time
Description

drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Time

Type de données

time

Alias
UMLS CUI [1,1]
C0599112
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0040223
Sample Number
Description

drug biological activity; Collection of blood specimen for laboratory procedure; Sample identification number

Type de données

integer

Alias
UMLS CUI [1,1]
C0599112
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C1299222
Pharmacokinetic aspects; Blood (GLP-1 total)
Description

Pharmacokinetic aspects; Blood (GLP-1 total)

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031328
UMLS CUI-3
C0061355
Planned Relative Time
Description

Pharmacokinetic aspects; Blood; relative time

Type de données

text

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

Pharmacokinetic aspects; Blood; Sampling; Date in time

Type de données

date

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

Pharmacokinetic aspects; Blood; Sampling; Time

Type de données

time

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

Pharmacokinetic aspects; Blood; Sample identification number

Type de données

integer

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

Type de données

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

Type de données

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

Type de données

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

Type de données

text

Alias
UMLS CUI [1]
C0877248
AE page number
Description

Adverse event; Page, Number

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

text

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

Day 13

1 Formulaires
  1. StudyEvent: ODM
    1. Day 13
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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; Relative time
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
12 lead ECG; Start Time
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (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)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Date in time
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Vital Signs; Relative Time
Code List
Planned Relative Time
CL Item
Day -1 (Day -1)
Vital Signs Time
Item
Actual Time
time
C2826762 (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 - Free Fatty Acids
C0373606 (UMLS CUI-1)
Free Fatty Acids measurement; Sampling; Date in time
Item
Date Sample Taken
date
C0373606 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Free Fatty Acids measurement; Sampling; Time
Item
Actual Time
time
C0373606 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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
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
Bioactivity Sampling; Blood
C0599112 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Item
Planned Relative Time
text
C0599112 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
drug biological activity; Collection of blood specimen for laboratory procedure; relative time
Code List
Planned Relative Time
CL Item
Day 9 (Day 9)
drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Date in time
Item
Date Sample Taken
date
C0599112 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
drug biological activity; Collection of blood specimen for laboratory procedure; Sampling; Time
Item
Actual Time
time
C0599112 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Sample Number
integer
C0599112 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
drug biological activity; Collection of blood specimen for laboratory procedure; Sample identification number
Code List
Sample Number
CL Item
601 (1)
Item Group
Pharmacokinetic aspects; Blood (GLP-1 total)
C0005834 (UMLS CUI-1)
C0031328 (UMLS CUI-2)
C0061355 (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 (Predose)
CL Item
12 hr (12 hr)
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
105 (1)
CL Item
106 (2)
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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