ID

35621

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 checklist (Concomitant Medication, Medical Procedure, RLS Rating, Adverse Experiences, CGI Rating and Exclusion criterion) form. Exclusion criterion has to be filled in only for baseline. RLS Rating and CGI Rating have to be checked for each visit. Medical procedure, concomitant medication and adverse experience have to be checked for: Screening/Baseline, Day 2, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 52, Early withdrawal and Follow-up

Keywords

  1. 3/12/19 3/12/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 12, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

Checklist (Concomitant Medication, Medical Procedure, RLS Rating, Adverse Experiences, CGI Rating and Exclusion criterion)

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Patient initials
Description

Patient initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section
Description

Concomitant Medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Medical Procedure
Description

Medical Procedure

Alias
UMLS CUI-1
C0199171
Please record any medical procedures performed since the last visit
Description

Medical Procedure

Data type

text

Alias
UMLS CUI [1]
C0199171
RLS Rating Scales
Description

RLS Rating Scales

Alias
UMLS CUI-1
C0450973
UMLS CUI-2
C0035258
Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
Description

Scales RLS

Data type

integer

Alias
UMLS CUI [1,1]
C0450973
UMLS CUI [1,2]
C0035258
Adverse Experiences
Description

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section.
Description

Adverse Events

Data type

boolean

Clinical Global Impression
Description

Clinical Global Impression

Alias
UMLS CUI-1
C3639708
Clinical Global Impression Questionaire completed?
Description

Clinical Global Impression

Data type

text

Alias
UMLS CUI [1]
C3639708
Exclusion Criterion
Description

Exclusion Criterion

Patient has clinically significant abnormal laboratory findings not resolved prior to baseline examinations.
Description

Only for Baseline/Screening Visit.

Data type

text

Alias
UMLS CUI [1]
C0680251

Similar models

Checklist (Concomitant Medication, Medical Procedure, RLS Rating, Adverse Experiences, CGI Rating and Exclusion criterion)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient initials
Item
Patient initials
text
C2986440 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
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
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section
boolean
C2347852 (UMLS CUI [1])
Item Group
Medical Procedure
C0199171 (UMLS CUI-1)
Medical Procedure
Item
Please record any medical procedures performed since the last visit
text
C0199171 (UMLS CUI [1])
Item Group
RLS Rating Scales
C0450973 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
Scales RLS
Item
Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
integer
C0450973 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Adverse Events
Item
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section.
boolean
Item Group
Clinical Global Impression
C3639708 (UMLS CUI-1)
Item
Clinical Global Impression Questionaire completed?
text
C3639708 (UMLS CUI [1])
Code List
Clinical Global Impression Questionaire completed?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Exclusion Criterion
Item
Patient has clinically significant abnormal laboratory findings not resolved prior to baseline examinations.
text
C0680251 (UMLS CUI [1])
Code List
Patient has clinically significant abnormal laboratory findings not resolved prior to baseline examinations.
CL Item
Yes (Y)
CL Item
No (N)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial