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GSK study: Ropinirole in RLS patients 101468/243 - Patient Rating Scales Baseline, Week 12, 24, 36, 48 and EW

- 30/07/17 - 1 modulo, 6 itemgroups, 24 elementi, 1 linguaggio

Itemgroups: Patient rated scale baseline, Patient rated scale week 12, Patient rated scale week 24, Patient rated scale week 36, Patient rated scale week 48, Patient rated scale early withdrawal

GSK study: Ropinirole in RLS patients 101468/243 - Patient Rating Scales Baseline, Week 12, 24, 36, 48 and EW Study ID: 101468/243 Clinical Study ID: 101468/243 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: N/A 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

GSK study: Ropinirole in RLS patients 101468/243 - RLS Forms Baseline, Day2 Week 1-52, Early withdrawal and Follow-up

- 30/07/17 - 1 modulo, 17 itemgroups, 17 elementi, 1 linguaggio

Itemgroups: RLS Rating scale - Baseline, RLS Rating scale - Day 2, RLS Rating scale - Week 1, RLS Rating scale - Week 2, RLS Rating scale - Week 3, RLS Rating scale - Week 4, RLS Rating scale - Week 5, RLS Rating scale - Week 6, RLS Rating scale - Week 7, RLS Rating scale - Week 8, RLS Rating scale - Week 12, RLS Rating scale - Week 24, RLS Rating scale - Week 36, RLS Rating scale - Week 48, RLS Rating scale - Week 52, RLS Rating scale - Early Withdrawal, RLS Rating scale - Follow-up

GSK study: Ropinirole in RLS patients 101468/243 - RLS Forms Baseline, Day2 Week 1-52, Early withdrawal and Follow-up Study ID: 101468/243 Clinical Study ID: 101468/243 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: N/A 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

GSK study: Ropinirole in RLS patients 101468/243 - Form Death

- 30/07/17 - 1 modulo, 1 ItemGroup, 7 elementi, 1 linguaggio

ItemGroup: Death Form

GSK study: Ropinirole in RLS patients 101468/243 - Form Death Study ID: 101468/243 Clinical Study ID: 101468/243 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: N/A 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

Eligbility GSK Ropinirole Restless Legs Syndrome 101468

- 30/07/17 - 1 modulo, 3 itemgroups, 30 elementi, 1 linguaggio

Itemgroups: Patient Data, Inclusion Criteria, Exclusion Criteria

Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome Eligibility

GSK study: Ropinirole in RLS patients 101468/243 - Follow up of Early Withdrawals 1 - GSK study: Ropinirole in RLS patients 101468/243 - Follow-up of Early Withdrawals 1

- 30/07/17 - 1 modulo, 13 itemgroups, 35 elementi, 1 linguaggio

Itemgroups: RLS Rating scale, Vital signs, Medical procedures, Concomitant Medication, Adverse reaction, Laboratory test, Urine dipstick, Medical procedures, Medical procedures, Concomitant medication, concomitant medication, Non-serious adverse event, Non-serious adverse event

Part 2 of EW1/FU1 - Early Withdrawals and Follow-up 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 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: N/A 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

GSK study: Ropinirole in RLS patients 101468/243 - Serious Adverse Experience 5 and 6

- 30/07/17 - 1 modulo, 1 ItemGroup, 58 elementi, 1 linguaggio

ItemGroup: Serious Adverse Experience

GSK study: Ropinirole in RLS patients 101468/243 - Serious Adverse Experience 5 and 6 Study ID: 101468/243 Clinical Study ID: 101468/243 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: N/A 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

GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1

- 30/07/17 - 1 modulo, 22 itemgroups, 49 elementi, 1 linguaggio

Itemgroups: Study medication record since last visit, RLS Rating scale, Vital signs, Medical procedures, Concomitant Medication, Adverse reaction, Patient rated scale, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Healthcare resource utilisation - accident & emergency / emergency room visits, Laboratory test, Urine dipstick, Pregnancy dipstick, Clinical global impression, Pregnancy information, Study conclusion, investigator signature

ONLY TO BE COMPLETED IF THE PATIENT IS WITHDRAWN Part 1 of EW1/ FU1: Early Withdrawal and Follow-up 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 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: N/A 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

Demography GSK Ropinirole Restless Legs Syndrome 101468

- 30/07/17 - 1 modulo, 2 itemgroups, 10 elementi, 1 linguaggio

Itemgroups: Patient Data, Demography

Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome Demography

GSK study: Ropinirole in RLS patients 101468/243 - Follow up - GSK study: Ropinirole in RLS patients 101468/243 - Follow-up

- 30/07/17 - 1 modulo, 18 itemgroups, 52 elementi, 1 linguaggio

Itemgroups: RLS Rating scale, Vital signs, Concomitant Medication, Adverse reaction, Medical procedures, Laboratory test, Urine dipstick, Study medication and compliance record, Dose changes, Medical procedures, Medical procedures, Concomitant medication, concomitant medication, Non-serious adverse event, Non-serious adverse event, Pregnancy information, Study conclusion, investigator signature

Part 2 of Module 12: Wk 52, Follow-Up & Study Conc 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 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: N/A 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

GSK study: Ropinirole in RLS patients 101468/243 - Serious Adverse Experience 3 and 4 - GSK study: Ropinirole in RLS patients 101468/243 - Serious Adverse Experience 3 and 4

- 30/07/17 - 1 modulo, 1 ItemGroup, 58 elementi, 1 linguaggio

ItemGroup: Serious Adverse Experience

GSK study: Ropinirole in RLS patients 101468/243 - Serious Adverse Experience 3 and 4 Study ID: 101468/243 Clinical Study ID: 101468/243 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: N/A 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

GSK study: Ropinirole in RLS patients 101468/243 - Week 52

- 30/07/17 - 1 modulo, 10 itemgroups, 18 elementi, 1 linguaggio

Itemgroups: Study medication record since last visit, RLS Rating scale, Vital signs, Laboratory test, Urine dipstick, Pregnancy dipstick, Medical procedures, Concomitant Medication, Adverse reaction, Clinical global impression

Part 1 of Module 12: Wk 52, Follow-Up & Study Conc 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 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: N/A 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

GSK study: Ropinirole in RLS patients 101468/243 - Week 48

- 30/07/17 - 1 modulo, 30 itemgroups, 78 elementi, 1 linguaggio

Itemgroups: Study medication record since last visit, RLS Rating scale, Vital signs, Medical procedures, Concomitant Medication, Adverse reaction, Patient rated scale, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - visits/contacts with physician, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Healthcare resource utilisation - accident & emergency / emergency room visits, Clinical global impression, Instructions for the investigator, Clinical Global impression, Dose modification, Study medication and compliance record, Dose changes, Medical procedures, Medical procedures, Concomitant medication, concomitant medication, Non-serious adverse event, Non-serious adverse event, Pregnancy information, Study Subject Participation Status, investigator signature

Module 9B: Wk 36 to Cont/Wthd 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 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: N/A 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

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