ID

25339

Descripción

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

Palabras clave

Versiones (1)
  1. 1/9/17 1/9/17 -
Subido en

1 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Early Withdrawal Day -2 (Form 17)

Inglés

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Early Withdrawal Day -2 (Form 17)

1 formularios  
General Information
Descripción

General Information

Center Number
Descripción

Center Number

Tipo de datos

integer

Patient Number
Descripción

Patient Number

Tipo de datos

integer

Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Visit Date
Descripción

Visit Date

Tipo de datos

date

Orthostatic Vital Signs
Descripción

Orthostatic Vital Signs

Time of dose
Descripción

Time of dose

Tipo de datos

time

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

integer

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

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

Tipo de datos

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 -2 (Form 17)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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