ID

36014

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the AE form. It has to be filled in for all Sessions each for both Day 1 and Day 2.

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  1. 09/04/2019 09/04/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

9 avril 2019

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Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

Anglais

Adverse Events (AE) for Sessions

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject No.
Description

Subject No.

Type de données

text

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Panel ID
Description

Panel ID

Type de données

text

Alias
UMLS CUI [1]
C3846158 (Other Coding)
LOINC
LA4728-7
Visit type
Description

Visit type

Type de données

integer

Alias
UMLS CUI [1,1]
C0545082 (Visit)
UMLS CUI [1,2]
C0332307 (Type - attribute)
SNOMED
261664005
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248 (Adverse event)
LOINC
MTHU014542
Planned relative time
Description

Note: Tick "+2h and +6h" only for Day 1. "+16h" is for Day 2 mandatory.

Type de données

integer

Alias
UMLS CUI [1]
C0439564 (Relative time)
SNOMED
118578006
LOINC
LP21276-8
Date
Description

day month year

Type de données

date

Alias
UMLS CUI [1]
C0011008 (Date in time)
SNOMED
410671006
Time
Description

00:00-23:59

Type de données

time

Alias
UMLS CUI [1]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
Have any Adverse Events been observed/reported?
Description

If YES, please complete the "Adverse Event" form.

Type de données

text

Alias
UMLS CUI [1]
C0877248 (Adverse event)
LOINC
MTHU014542
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Similar models

Adverse Events (AE) for Sessions

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Session 1 day 1 (1)
CL Item
Session 1 day 2 (2)
CL Item
Session 2 day 1  (3)
CL Item
Session 2 day 2 (4)
CL Item
Session 3 day 1 (5)
CL Item
Session 3 day 2 (6)
CL Item
Session 4 day 1 (7)
CL Item
Session 4 day 2 (8)
CL Item
Session 5 day 1 (9)
CL Item
Session 5 day 2 (10)
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Item
Planned relative time
integer
C0439564 (UMLS CUI [1])
Planned relative time
Code List
Planned relative time
CL Item
+2h (1)
CL Item
+6h (2)
CL Item
+16h (3)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Item
Have any Adverse Events been observed/reported?
text
C0877248 (UMLS CUI [1])
Adverse event observed
Code List
Have any Adverse Events been observed/reported?
CL Item
No (N)
CL Item
Yes (Y)
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