ID

26883

Beschrijving

Study ID: 101468/199 Clinical Study ID: 101468/199 Study Title: An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome Documentation part (Visit Description): Non-Serious Adverse Event

Trefwoorden

Versies (1)
  1. 27-10-17 27-10-17 -
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GlaxoSmithKline

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27 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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Pharmacokinetics of a new unmarketed formulation of ropinirole Non-Serious Adverse Event 101468/199

Engels

Non-Serious Adverse Event

1 Formulieren  
Non-Serious Adverse Event
Beschrijving

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C0244821
Did the subject experience any non-serious adverse events during the study?
Beschrijving

If Yes, record details below. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
Event
Beschrijving

Diagnosis Only (if known). Otherwise Sign/Symptom

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011900
Start date Non-Serious Adverse Event
Beschrijving

Start date Non-Serious Adverse Event

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Start Time Non-Serious Adverse Event
Beschrijving

Start Time Non-Serious Adverse Event

Datatype

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2697889
Outcome Non-Serious Adverse Event
Beschrijving

Outcome Non-Serious Adverse Event

Datatype

integer

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]
C0806020
End Time Non-Serious Adverse Event
Beschrijving

End Time Non-Serious Adverse Event

Datatype

text

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

Frequency of Non-Serious Adverse Event

Datatype

integer

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

Non-Serious Adverse Event

Datatype

integer

Alias
UMLS CUI [1,1]
C1710066
UMLS CUI [1,2]
C1518404
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschrijving

Action Taken

Datatype

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C1518404
Did the subject withdraw from study as a result of this AE?
Beschrijving

withdrawal

Datatype

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

AE caused by the investigational product

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
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 Event
C1518404 (UMLS CUI-1)
C0244821 (UMLS CUI-2)
non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Event
Item
Event
text
C1518404 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Start date Non-Serious Adverse Event
Item
Start date Non-Serious Adverse Event
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time Non-Serious Adverse Event
Item
Start Time Non-Serious Adverse Event
time
C1518404 (UMLS CUI [1,1])
C2697889 (UMLS CUI [1,2])
Item
Outcome Non-Serious Adverse Event
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome Non-Serious Adverse Event
CL Item
Recovered/Resolved (1)
C2826210 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering/Resolving (2)
C0521108 (UMLS CUI-1)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
C1709277 (UMLS CUI-1)
(Comment:en)
CL Item
Recovered/Resolved withsequelae (4)
C1709862 (UMLS CUI-1)
(Comment:en)
End Date Non-Serious Adverse Event
Item
End Date Non-Serious Adverse Event
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time Non-Serious Adverse Event
Item
End Time Non-Serious Adverse Event
text
C2826658 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Frequency of Non-Serious Adverse Event
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Frequency of Non-Serious Adverse Event
Code List
Frequency of Non-Serious Adverse Event
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
integer
C1710066 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
Severe (3)
C0205082 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
C2826626 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action Taken
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
C1875319 (UMLS CUI-1)
(Comment:en)
CL Item
Dose reduced (2)
C1707814 (UMLS CUI-1)
(Comment:en)
CL Item
Dose increased (3)
C1707810 (UMLS CUI-1)
(Comment:en)
CL Item
Dose not changed (4)
C0178602 (UMLS CUI-1)
C0443172 (UMLS CUI-2)
(Comment:en)
CL Item
Dose interrupted (5)
C1512900 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
(Comment:en)
CL Item
Not applicable (6)
withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
C2349954 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
AE caused by the investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
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