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
Versions (1)
- 3/12/19 3/12/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 12, 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
Checklist (Concomitant Medication, Medical Procedure, RLS Rating, Adverse Experiences, CGI Rating and Exclusion criterion)
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Medical Procedure
Alias
- UMLS CUI-1
- C0199171
Description
RLS Rating Scales
Alias
- UMLS CUI-1
- C0450973
- UMLS CUI-2
- C0035258
Description
Adverse Experiences
Alias
- UMLS CUI-1
- C0877248
Description
Clinical Global Impression
Alias
- UMLS CUI-1
- C3639708
Description
Exclusion Criterion
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Checklist (Concomitant Medication, Medical Procedure, RLS Rating, Adverse Experiences, CGI Rating and Exclusion criterion)
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