ID

35677

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 concomitant medication form. It has to be filled in if the subject takes concomitant medication during the study.

Keywords

  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

Concomitant Medication

  1. StudyEvent: ODM
    1. Concomitant Medication
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
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
No new/change in concomitant medication
Description

Please mark if no new or change in concomitant medication during the module

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0580105
Drug Name
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose
Description

Total Daily Dose

Data type

integer

Alias
UMLS CUI [1]
C2348070
Medical illness/ Diagnosis
Description

(or symptom in absence of diagnosis)

Data type

text

Alias
UMLS CUI [1]
C0011900
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1]
C0806020

Similar models

Concomitant Medication

  1. StudyEvent: ODM
    1. Concomitant Medication
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])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
No new/change in concomitant medication
Item
No new/change in concomitant medication
boolean
C2347852 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0580105 (UMLS CUI [1,3])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
integer
C2348070 (UMLS CUI [1])
Diagnosis
Item
Medical illness/ Diagnosis
text
C0011900 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])

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