ID

31970

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. 09-10-18 09-10-18 -
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GlaxoSmithKline

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9 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

Non-Serious Adverse Events

1 Formulieren  
Non-Serious Adverse Events
Beschrijving

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Beschrijving

Non-Serious Adverse Event; During; Clinical Trial Period

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Event (Diagnosis Only (if known) Otherwise Sign/Symptom)
Beschrijving

Non-Serious Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C1518404
Start Date
Beschrijving

Non-Serious Adverse Event; Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Start Time
Beschrijving

Non-Serious Adverse Event; Start Time

Datatype

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
Outcome
Beschrijving

Non-Serious Adverse Event; Adverse Event Outcome

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
End Date
Beschrijving

Non-Serious Adverse Event; End Date

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
End Time
Beschrijving

Non-Serious Adverse Event; Adverse Event End Time

Datatype

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826658
Frequency
Beschrijving

Non-Serious Adverse Event; Frequencies

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity
Beschrijving

Non-Serious Adverse Event; Symptom Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschrijving

Non-Serious Adverse Event; Action taken with investigational product

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this AE?
Beschrijving

Non-Serious Adverse Event; Patient withdrawn from trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0422727
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Non-Serious Adverse Event; Investigational New Drugs; Relationships

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
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Similar models

Non-Serious Adverse Events

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event; During; Clinical Trial Period
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Non-Serious Adverse Event
Item
Event (Diagnosis Only (if known) Otherwise Sign/Symptom)
text
C1518404 (UMLS CUI [1])
Non-Serious Adverse Event; Start Date
Item
Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-Serious Adverse Event; Start Time
Item
Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event; Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/ Resolved  (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
Non-Serious Adverse Event; End Date
Item
End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Non-Serious Adverse Event; Adverse Event End Time
Item
End Time
time
C1518404 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-Serious Adverse Event; Frequencies
Code List
Frequency
CL Item
Single episode  (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Non-Serious Adverse Event; Frequencies
Code List
Maximum Intensity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe  (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
C1518404 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-Serious Adverse Event; Frequencies
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn  (1)
CL Item
Dose reduced  (2)
CL Item
Dose increased (3)
CL Item
Dose not changed  (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Non-Serious Adverse Event; Patient withdrawn from trial
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Non-Serious Adverse Event; Investigational New Drugs; Relationships
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
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