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Ropinirole Case Report Form GSK RRL100013 - Serious Adverse Event (SAE)

- 17/09/2021 - 4 Formulários, 11 Grupos de itens, 41 Elementos de dados, 1 Idioma
Grupos de itens: Serious Adverse Event (SAE) Section 1, SECTION 2 Seriousness, SECTION 3 Demography Data, SECTION 4, SECTION 5, SECTION 6, SECTION 7, Document section Concomitant Medications, Drug Details, Assessments, Narrative Remarks
Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

PREGNANCY INFORMATION

6 Grupos de itens 78 Elementos de dados

Subject diary

7 Grupos de itens 30 Elementos de dados

SERIOUS ADVERSE EVENT

2 Grupos de itens 13 Elementos de dados

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Serious Adverse Event (SAE)

- 09/04/2019 - 1 Formulário, 6 Grupos de itens, 47 Elementos de dados, 1 Idioma
Grupos de itens: Administrative data, Serious Adverse Event (SAE), SAE, reason, Assessment, Relevant Laboratory Data, Details SAE
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 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 a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the SAE form. It has to be filled in if the subject experience a SAE during the study trial.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Adverse Events (AE) for Sessions

- 09/04/2019 - 1 Formulário, 2 Grupos de itens, 7 Elementos de dados, 1 Idioma
Grupos de itens: Administrative data, Adverse event
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 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 a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the AE form. It has to be filled in for all Sessions each for both Day 1 and Day 2.

Dose strength equivalence of ropinirole CR in healthy adults Serious Adverse Event 101468/219 - Serious Adverse Event Dose strength equivalence of ropinirole CR in healthy adults 101468/219

- 09/10/2017 - 1 Formulário, 2 Grupos de itens, 34 Elementos de dados, 1 Idioma
Grupos de itens: Serious Adverse Event, Relevant Laboratory Data
Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Parkinson Disease Documentation part: Serious Adverse Event

Dose strength equivalence of ropinirole CR in healthy adults Adverse Event 101468/219 - Adverse Event Dose strength equivalence of ropinirole CR in healthy adults 101468/219

- 09/10/2017 - 1 Formulário, 1 Grupo de itens, 13 Elementos de dados, 1 Idioma
Grupo de itens: Adverse Event
Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Parkinson Disease Documentation part: Adverse Event

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