ID

32041

Beschrijving

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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Versies (1)
  1. 15-10-18 15-10-18 -
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GlaxoSmithKline

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15 oktober 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

Engels

Hypoglycaemic Events

1 Formulieren  
  1. StudyEvent: ODM
    1. Hypoglycaemic Events
Hypoglycaemic Events
Beschrijving

Hypoglycaemic Events

Alias
UMLS CUI-1
C0342312
Start Date of Event
Beschrijving

Hypoglycaemic Event in Diabetes; Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0808070
Start Time of Event
Beschrijving

Hypoglycaemic Event in Diabetes; Start Time

Datatype

time

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1301880
End Date of Event
Beschrijving

Hypoglycaemic Event in Diabetes; End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0806020
End Time of Event
Beschrijving

Hypoglycaemic Event in Diabetes; End Time

Datatype

time

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1522314
Prior to Hypoglycaemic Event: Date / Time of Last Food Intake
Beschrijving

Hypoglycaemic Event in Diabetes; Time of last food intake; Date in Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0578574
UMLS CUI [1,3]
C0011008
Prior to Hypoglycaemic Event: Date / Time of Last Blood Glucose
Beschrijving

Hypoglycaemic Event in Diabetes; Plasma Glucose Measurement; Date in time; Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0202042
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Prior to Hypoglycaemic Event: Result of Last Blood Glucose
Beschrijving

Hypoglycaemic Event in Diabetes; Before; Plasma Glucose Measurement; Result

Datatype

text

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0202042
UMLS CUI [1,4]
C1274040
Blood Glucose Test Result at Time of Event
Beschrijving

Hypoglycaemic Event in Diabetes; Plasma Glucose Measurement; Result

Datatype

integer

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0202042
UMLS CUI [1,3]
C1274040
Blood Glucose Test Units
Beschrijving

Hypoglycaemic event in diabetes; Plasma Glucose Measurement; Unit of Measure

Datatype

integer

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0202042
UMLS CUI [1,3]
C1519795
Frequency
Beschrijving

Hypoglycaemic event in diabetes; Frequencies

Datatype

text

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0439603
Outcome
Beschrijving

Hypoglycaemic event in diabetes; Patient Outcome

Datatype

text

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1547647
Intervention
Beschrijving

Hypoglycaemic event in diabetes; Interventional Procedure

Datatype

text

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0184661
Maximum Intensity
Beschrijving

Hypoglycaemic event in diabetes; Symptom Intensity

Datatype

text

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0518690
Action Taken With Respect to Investigational Product
Beschrijving

Hypoglycaemic event in diabetes; Action Taken with Study Treatment

Datatype

text

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1704758
Did this event meet the definition of an SAE?
Beschrijving

Hypoglycaemic event in diabetes; Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1519255
Did the subject experience symptoms usually associated with hypoglycaemia?
Beschrijving

Hypoglycaemic event in diabetes; Symptoms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1457887
Did the subject require external assistance (defined as unable to help themselves)?
Beschrijving

Hypoglycaemic event in diabetes; Supportive Assistance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C1521721
Relationship to Investigational Product: Is there a reasonable possibility that the hypoglycaemic event may have been caused by the investigational product?
Beschrijving

Hypoglycaemic event in diabetes; Causations; Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0013230
Withdrawal: Did the subject withdraw from the study as a result of this hypoglycaemic event?
Beschrijving

Hypoglycaemic event in diabetes; Causations; Withdraw

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342312
UMLS CUI [1,2]
C2349954
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Similar models

Hypoglycaemic Events

1 Formulieren
  1. StudyEvent: ODM
    1. Hypoglycaemic Events
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Hypoglycaemic Events
C0342312 (UMLS CUI-1)
Hypoglycaemic Event in Diabetes; Start Date
Item
Start Date of Event
date
C0342312 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Hypoglycaemic Event in Diabetes; Start Time
Item
Start Time of Event
time
C0342312 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Hypoglycaemic Event in Diabetes; End Date
Item
End Date of Event
date
C0342312 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Hypoglycaemic Event in Diabetes; End Time
Item
End Time of Event
time
C0342312 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Hypoglycaemic Event in Diabetes; Time of last food intake; Date in Time
Item
Prior to Hypoglycaemic Event: Date / Time of Last Food Intake
datetime
C0342312 (UMLS CUI [1,1])
C0578574 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hypoglycaemic Event in Diabetes; Plasma Glucose Measurement; Date in time; Time
Item
Prior to Hypoglycaemic Event: Date / Time of Last Blood Glucose
datetime
C0342312 (UMLS CUI [1,1])
C0202042 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Hypoglycaemic Event in Diabetes; Before; Plasma Glucose Measurement; Result
Item
Prior to Hypoglycaemic Event: Result of Last Blood Glucose
text
C0342312 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0202042 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Hypoglycaemic Event in Diabetes; Plasma Glucose Measurement; Result
Item
Blood Glucose Test Result at Time of Event
integer
C0342312 (UMLS CUI [1,1])
C0202042 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Blood Glucose Test Units
integer
C0342312 (UMLS CUI [1,1])
C0202042 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Hypoglycaemic event in diabetes; Plasma Glucose Measurement; Unit of Measure
Code List
Blood Glucose Test Units
CL Item
mg/dL (1)
CL Item
mmol/L (2)
Item
Frequency
text
C0342312 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Plasma Glucose Measurement; Unit of Measure
Code List
Frequency
Hypoglycaemic event in diabetes; Patient Outcome
Item
Outcome
text
C0342312 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Interventional Procedure
Item
Intervention
text
C0342312 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Symptom Intensity
Item
Maximum Intensity
text
C0342312 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Action Taken with Study Treatment
Item
Action Taken With Respect to Investigational Product
text
C0342312 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Serious Adverse Event
Item
Did this event meet the definition of an SAE?
boolean
C0342312 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Symptoms
Item
Did the subject experience symptoms usually associated with hypoglycaemia?
boolean
C0342312 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Supportive Assistance
Item
Did the subject require external assistance (defined as unable to help themselves)?
boolean
C0342312 (UMLS CUI [1,1])
C1521721 (UMLS CUI [1,2])
Hypoglycaemic event in diabetes; Causations; Investigational New Drugs
Item
Relationship to Investigational Product: Is there a reasonable possibility that the hypoglycaemic event may have been caused by the investigational product?
boolean
C0342312 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Hypoglycaemic event in diabetes; Causations; Withdraw
Item
Withdrawal: Did the subject withdraw from the study as a result of this hypoglycaemic event?
boolean
C0342312 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
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