ID

36895

Description

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new 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 The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the AE/ Concomitant Medication Probe form. It has to be filled in for each study day (Day1-Day19) and for Follow-up.

Keywords

Versions (2)
  1. 9/2/17 9/2/17 -
  2. 6/19/19 6/19/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 19, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

English

AE/ Concomitant Medication Probe

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Study Week
Description

Study Week

Data type

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0439230
Study Day
Description

Please note the study day: Day 1- Day 19, follow-up.

Data type

text

Measurement units
  • day
Alias
UMLS CUI [1]
C2826182
day
AE, Concomitant Medication
Description

AE, Concomitant Medication

Alias
UMLS CUI-1
C2347852
Time relative to start of dose
Description

Note: Pre-dose only is to be queried for Day 1. Timing +24 hrs is to be queried prior to next dose. For Follow-up: There is no specific time.

Data type

integer

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0178602
Subject asked
Description

If you tick no, please comment in the item "Comment".

Data type

text

Alias
UMLS CUI [1]
C0566217
Comment
Description

Fill in if subject was not asked.

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

AE/ Concomitant Medication Probe

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Study Week
integer
C0008972 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Study Week
Code List
Study Week
CL Item
Week 1 (1)
CL Item
Week 2 (2)
CL Item
Week 3 (3)
CL Item
Follow-up (4)
Study Day
Item
Study Day
text
C2826182 (UMLS CUI [1])
Item Group
AE, Concomitant Medication
C2347852 (UMLS CUI-1)
Item
Time relative to start of dose
integer
C0040223 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Time relative to start of dose
Code List
Time relative to start of dose
CL Item
Pre-dose (1)
CL Item
+2 hrs (2)
CL Item
+6 hrs (3)
CL Item
+16 hrs (4)
CL Item
+24 hrs (5)
Item
Subject asked
text
C0566217 (UMLS CUI [1])
Subject asked
Code List
Subject asked
CL Item
Yes (Y)
CL Item
No (N)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
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