ID

35684

Description

Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title:A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 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 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the Study Medication And Compliance Record form. It has to be filled in for each Visit. It also cntains the Dose reduction due to AE form. It has to be filled in for Week 12-48 and Follow-up.

Keywords

Versions (1)
  1. 3/15/19 3/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 15, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192

English

Study Medication And Compliance Record, Dose reduction due to AE

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Study Medication And Compliance Record
Description

Study Medication And Compliance Record

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
UMLS CUI-3
C1321605
Study Medication Week Number
Description

Week Number

Data type

integer

Alias
UMLS CUI [1,1]
C0439230
UMLS CUI [1,2]
C0237753
Dose Level (Specify 1 - 8)
Description

Dose Level

Data type

integer

Alias
UMLS CUI [1]
C0178602
Date First Dose
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C3173309
Last Dose Date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
Number of tablets dispensed
Description

Number of tablets dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0304229
Number of tablets returned
Description

Number of tablets returned

Data type

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0304229
Dose Reductions Due to Adverse Experiences
Description

Dose Reductions Due to Adverse Experiences

Alias
UMLS CUI-1
C1707814
UMLS CUI-2
C0559546
Week
Description

Week

Data type

integer

Alias
UMLS CUI [1]
C0439230
Dose Level
Description

Dose Level

Data type

integer

Alias
UMLS CUI [1]
C0178602
Date First Dose
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C3173309
Last Dose Date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
Number of tablets dispensed
Description

Number of tablets dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0304229
Number of tablets returned
Description

Number of tablets returned

Data type

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0304229
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Similar models

Study Medication And Compliance Record, Dose reduction due to AE

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C1830427 (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
Screening/Baseline (1)
CL Item
Day 2 (2)
CL Item
Week 1 (3)
CL Item
Week 2  (4)
CL Item
Week 3  (5)
CL Item
Week 4 (6)
CL Item
Week 5 (7)
CL Item
Week 6 (8)
CL Item
Week 7 (9)
CL Item
Week 8  (10)
CL Item
Week 12 (11)
CL Item
Week 24 (12)
CL Item
Week 36 (13)
CL Item
Week 48 (14)
CL Item
Week 52 (15)
CL Item
Early withdrawal (16)
CL Item
Follow-up (17)
Item Group
Study Medication And Compliance Record
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C1321605 (UMLS CUI-3)
Item
Study Medication Week Number
integer
C0439230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Week Number
Code List
Study Medication Week Number
CL Item
Week 1 (Days 1-2) (1)
CL Item
Week 1 (Days 3-7) (2)
CL Item
Week 2 (3)
CL Item
Week 3 (4)
CL Item
Week 4 (5)
CL Item
Week 5 (6)
CL Item
Week 6 (7)
CL Item
Week 7 (8)
CL Item
Week 8 (9)
CL Item
Week 9-12 (10)
CL Item
Week 13-24 (11)
CL Item
Week 25-36 (12)
CL Item
Week 37-48 (13)
CL Item
Week 49-52 (14)
Dose Level
Item
Dose Level (Specify 1 - 8)
integer
C0178602 (UMLS CUI [1])
First Dose Date
Item
Date First Dose
date
C3173309 (UMLS CUI [1])
last Dose Date
Item
Last Dose Date
date
C0178602 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Number of tablets dispensed
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Dose Reductions Due to Adverse Experiences
C1707814 (UMLS CUI-1)
C0559546 (UMLS CUI-2)
Week
Item
Week
integer
C0439230 (UMLS CUI [1])
Dose Level
Item
Dose Level
integer
C0178602 (UMLS CUI [1])
First Dose Date
Item
Date First Dose
date
C3173309 (UMLS CUI [1])
last Dose Date
Item
Last Dose Date
date
C0178602 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Number of tablets dispensed
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
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