ID

29502

Beschrijving

Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Non-Serious Adverse Event

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Versies (1)
  1. 04-04-18 04-04-18 -
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GlaxoSmithKline

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4 april 2018

DOI

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Creative Commons BY-NC 3.0
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Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257

Engels

Non-Serious Adverse Event

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 Events

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
Non-serious adverse event: Diagnosis only (if known) or signs / symptoms (list one per line)
Beschrijving

Non-serious adverse events

Datatype

text

Alias
UMLS CUI [1]
C1518404
Date of onset Non-Serious Adverse Event
Beschrijving

Date of onset Non-Serious Adverse Event

Datatype

date

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C1518404
Time of onset Non-Serious Adverse Event
Beschrijving

Time of onset Non-Serious Adverse Event

Datatype

time

Alias
UMLS CUI [1,1]
C2697889
UMLS CUI [1,2]
C1518404
Outcome
Beschrijving

Outcome

Datatype

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
End date Non-Serious Adverse Event
Beschrijving

End date Non-Serious Adverse Event

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2697886
End time Non-Serious Adverse Event
Beschrijving

End time Non-Serious Adverse Event

Datatype

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826658
Frequency Non-Serious Adverse Event
Beschrijving

Frequency Non-Serious Adverse Event

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity Non-Serious Adverse Event
Beschrijving

Maximum Intensity Non-Serious Adverse Event

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1518404
Action taken with investigational product(s) as a result of the non-serious AE
Beschrijving

Action taken with investigational product

Datatype

integer

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

subject withdraw from study

Datatype

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Relationship to Investigational Product

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
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Similar models

Non-Serious Adverse Event

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-Serious Adverse Events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Non-serious adverse events
Item
Non-serious adverse event: Diagnosis only (if known) or signs / symptoms (list one per line)
text
C1518404 (UMLS CUI [1])
Date of onset Non-Serious Adverse Event
Item
Date of onset Non-Serious Adverse Event
date
C2985916 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time of onset Non-Serious Adverse Event
Item
Time of onset Non-Serious Adverse Event
time
C2697889 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
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)
End date Non-Serious Adverse Event
Item
End date Non-Serious Adverse Event
date
C1518404 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
End time Non-Serious Adverse Event
Item
End time Non-Serious Adverse Event
time
C1518404 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
Frequency Non-Serious Adverse Event
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Frequency Non-Serious Adverse Event
Code List
Frequency Non-Serious Adverse Event
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity Non-Serious Adverse Event
integer
C0518690 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity Non-Serious Adverse Event
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
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action taken with investigational product
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
Investigationalproduct(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)
subject withdraw from study
Item
Did subject withdraw from study as a result of this non-serious AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Relationship to Investigational Product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
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