ID

25341

Descrição

Study ID: 101468/191 Clinical Study ID: SKF-101468/191 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Ropinirole in Subjects with Restless Legs Syndrome (RLS) Suffering from Periodic Leg Movements of Sleep (PLMS) 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: Requip Study Indication: Restless Legs Syndrome

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Versões (1)
  1. 01/09/2017 01/09/2017 -
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1 de setembro de 2017

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Licença

Creative Commons BY-NC 3.0
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Early Withdrawal Day -1 (Form 18)

Inglês

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Early Withdrawal Day -1 (Form 18)

1 Formulários  
General Information
Descrição

General Information

Center Number
Descrição

Center Number

Tipo de dados

integer

Patient Number
Descrição

Patient Number

Tipo de dados

integer

Patient Initials
Descrição

Patient Initials

Tipo de dados

text

Visit Date
Descrição

Visit Date

Tipo de dados

date

Orthostatic Vital Signs
Descrição

Orthostatic Vital Signs

Time of dose
Descrição

Time of dose

Tipo de dados

time

Pre-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (systolic)
Descrição

Pre-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (systolic)

Tipo de dados

integer

Pre-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (diastolic)
Descrição

Pre-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (diastolic)

Tipo de dados

integer

Pre-Dose (Reading 1) After 10 minutes semi-supine Pulse
Descrição

Pre-Dose (Reading 1) After 10 minutes semi-supine Pulse

Tipo de dados

integer

Unidades de medida
  • beats/min
beats/min
Pre-Dose (Reading 1) Blood pressure after erect for 1 minute (systolic)
Descrição

Pre-Dose (Reading 1) Blood pressure after erect for 1 minute (systolic)

Tipo de dados

integer

Pre-Dose (Reading 1) Blood pressure after erect for 1 minute (diastolic)
Descrição

Pre-Dose (Reading 1) Blood pressure after erect for 1 minute (diastolic)

Tipo de dados

integer

Pre-Dose (Reading 1) pulse after erect for 1 minute
Descrição

Pre-Dose (Reading 1) pulse after erect for 1 minute

Tipo de dados

integer

Unidades de medida
  • beats/min
beats/min
Pre-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (systolic)
Descrição

Pre-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (systolic)

Tipo de dados

integer

Pre-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (diastolic)
Descrição

Pre-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (diastolic)

Tipo de dados

integer

Pre-Dose (Reading 2) After 10 minutes semi-supine Pulse
Descrição

Pre-Dose (Reading 2) After 10 minutes semi-supine Pulse

Tipo de dados

integer

Unidades de medida
  • beats/min
beats/min
Pre-Dose (Reading 2) Blood pressure after erect for 1 minute (systolic)
Descrição

Pre-Dose (Reading 2) Blood pressure after erect for 1 minute (systolic)

Tipo de dados

integer

Pre-Dose (Reading 2) Blood pressure after erect for 1 minute (diastolic)
Descrição

Pre-Dose (Reading 2) Blood pressure after erect for 1 minute (diastolic)

Tipo de dados

integer

Pre-Dose (Reading 2) Pulse after erect for 1 minute
Descrição

Pre-Dose (Reading 2) Pulse after erect for 1 minute

Tipo de dados

integer

Unidades de medida
  • beats/min
beats/min
2 hours Post-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (systolic)
Descrição

2 hours Post-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (systolic)

Tipo de dados

integer

2 hours Post-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (diastolic)
Descrição

2 hours Post-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (diastolic)

Tipo de dados

integer

2 hours Post-Dose (Reading 1) After 10 minutes semi-supine Pulse
Descrição

2 hours Post-Dose (Reading 1) After 10 minutes semi-supine Pulse

Tipo de dados

integer

Unidades de medida
  • beats/min
beats/min
2 hours Post-Dose (Reading 1) Blood pressure after erect for 1 minute (systolic)
Descrição

2 hours Post-Dose (Reading 1) Blood pressure after erect for 1 minute (systolic)

Tipo de dados

integer

2 hours Post-Dose (Reading 1) Blood pressure after erect for 1 minute (diastolic)
Descrição

2 hours Post-Dose (Reading 1) Blood pressure after erect for 1 minute (diastolic)

Tipo de dados

integer

2 hours Post-Dose (Reading 1) Pulse after erect for 1 minute
Descrição

2 hours Post-Dose (Reading 1) Pulse after erect for 1 minute

Tipo de dados

integer

Unidades de medida
  • beats/min
beats/min
2 hours Post-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (systolic)
Descrição

2 hours Post-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (systolic)

Tipo de dados

integer

2 hours Post-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (diastolic)
Descrição

2 hours Post-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (diastolic)

Tipo de dados

integer

2 hours Post-Dose (Reading 2) After 10 minutes semi-supine Pulse
Descrição

2 hours Post-Dose (Reading 2) After 10 minutes semi-supine Pulse

Tipo de dados

integer

Unidades de medida
  • beats/min
beats/min
2 hours Post-Dose (Reading 2) Blood pressure after erect for 1 minute (systolic)
Descrição

2 hours Post-Dose (Reading 2) Blood pressure after erect for 1 minute (systolic)

Tipo de dados

integer

2 hours Post-Dose (Reading 2) Blood pressure after erect for 1 minute (diastolic)
Descrição

2 hours Post-Dose (Reading 2) Blood pressure after erect for 1 minute (diastolic)

Tipo de dados

integer

2 hours Post-Dose (Reading 2) Pulse after erect for 1 minute
Descrição

2 hours Post-Dose (Reading 2) Pulse after erect for 1 minute

Tipo de dados

integer

Unidades de medida
  • beats/min
beats/min
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Similar models

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Early Withdrawal Day -1 (Form 18)

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
General Information
Center Number
Item
Center Number
integer
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
Visit Date
Item
Visit Date
date
Item Group
Orthostatic Vital Signs
Time of dose
Item
Time of dose
time
Pre-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (systolic)
Item
Pre-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (systolic)
integer
Pre-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (diastolic)
Item
Pre-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (diastolic)
integer
Pre-Dose (Reading 1) After 10 minutes semi-supine Pulse
Item
Pre-Dose (Reading 1) After 10 minutes semi-supine Pulse
integer
Pre-Dose (Reading 1) Blood pressure after erect for 1 minute (systolic)
Item
Pre-Dose (Reading 1) Blood pressure after erect for 1 minute (systolic)
integer
Pre-Dose (Reading 1) Blood pressure after erect for 1 minute (diastolic)
Item
Pre-Dose (Reading 1) Blood pressure after erect for 1 minute (diastolic)
integer
Pre-Dose (Reading 1) pulse after erect for 1 minute
Item
Pre-Dose (Reading 1) pulse after erect for 1 minute
integer
Pre-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (systolic)
Item
Pre-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (systolic)
integer
Pre-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (diastolic)
Item
Pre-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (diastolic)
integer
Pre-Dose (Reading 2) After 10 minutes semi-supine Pulse
Item
Pre-Dose (Reading 2) After 10 minutes semi-supine Pulse
integer
Pre-Dose (Reading 2) Blood pressure after erect for 1 minute (systolic)
Item
Pre-Dose (Reading 2) Blood pressure after erect for 1 minute (systolic)
integer
Pre-Dose (Reading 2) Blood pressure after erect for 1 minute (diastolic)
Item
Pre-Dose (Reading 2) Blood pressure after erect for 1 minute (diastolic)
integer
Pre-Dose (Reading 2) Pulse after erect for 1 minute
Item
Pre-Dose (Reading 2) Pulse after erect for 1 minute
integer
2 hours Post-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (systolic)
Item
2 hours Post-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (systolic)
integer
2 hours Post-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (diastolic)
Item
2 hours Post-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (diastolic)
integer
2 hours Post-Dose (Reading 1) After 10 minutes semi-supine Pulse
Item
2 hours Post-Dose (Reading 1) After 10 minutes semi-supine Pulse
integer
2 hours Post-Dose (Reading 1) Blood pressure after erect for 1 minute (systolic)
Item
2 hours Post-Dose (Reading 1) Blood pressure after erect for 1 minute (systolic)
integer
2 hours Post-Dose (Reading 1) Blood pressure after erect for 1 minute (diastolic)
Item
2 hours Post-Dose (Reading 1) Blood pressure after erect for 1 minute (diastolic)
integer
2 hours Post-Dose (Reading 1) Pulse after erect for 1 minute
Item
2 hours Post-Dose (Reading 1) Pulse after erect for 1 minute
integer
2 hours Post-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (systolic)
Item
2 hours Post-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (systolic)
integer
2 hours Post-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (diastolic)
Item
2 hours Post-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (diastolic)
integer
2 hours Post-Dose (Reading 2) After 10 minutes semi-supine Pulse
Item
2 hours Post-Dose (Reading 2) After 10 minutes semi-supine Pulse
integer
2 hours Post-Dose (Reading 2) Blood pressure after erect for 1 minute (systolic)
Item
2 hours Post-Dose (Reading 2) Blood pressure after erect for 1 minute (systolic)
integer
2 hours Post-Dose (Reading 2) Blood pressure after erect for 1 minute (diastolic)
Item
2 hours Post-Dose (Reading 2) Blood pressure after erect for 1 minute (diastolic)
integer
2 hours Post-Dose (Reading 2) Pulse after erect for 1 minute
Item
2 hours Post-Dose (Reading 2) Pulse after erect for 1 minute
integer
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