ID

25341

Beschrijving

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

Trefwoorden

  1. 01-09-17 01-09-17 -
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1 september 2017

DOI

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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)

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

General Information
Beschrijving

General Information

Center Number
Beschrijving

Center Number

Datatype

integer

Patient Number
Beschrijving

Patient Number

Datatype

integer

Patient Initials
Beschrijving

Patient Initials

Datatype

text

Visit Date
Beschrijving

Visit Date

Datatype

date

Orthostatic Vital Signs
Beschrijving

Orthostatic Vital Signs

Time of dose
Beschrijving

Time of dose

Datatype

time

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

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

Datatype

integer

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

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

Datatype

integer

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

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

Datatype

integer

Maateenheden
  • beats/min
beats/min
Pre-Dose (Reading 1) Blood pressure after erect for 1 minute (systolic)
Beschrijving

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

Datatype

integer

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

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

Datatype

integer

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

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

Datatype

integer

Maateenheden
  • beats/min
beats/min
Pre-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (systolic)
Beschrijving

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

Datatype

integer

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

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

Datatype

integer

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

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

Datatype

integer

Maateenheden
  • beats/min
beats/min
Pre-Dose (Reading 2) Blood pressure after erect for 1 minute (systolic)
Beschrijving

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

Datatype

integer

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

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

Datatype

integer

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

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

Datatype

integer

Maateenheden
  • beats/min
beats/min
2 hours Post-Dose (Reading 1) Blood pressure after 10 minutes semi-supine (systolic)
Beschrijving

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

Datatype

integer

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

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

Datatype

integer

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

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

Datatype

integer

Maateenheden
  • beats/min
beats/min
2 hours Post-Dose (Reading 1) Blood pressure after erect for 1 minute (systolic)
Beschrijving

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

Datatype

integer

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

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

Datatype

integer

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

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

Datatype

integer

Maateenheden
  • beats/min
beats/min
2 hours Post-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (systolic)
Beschrijving

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

Datatype

integer

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

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

Datatype

integer

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

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

Datatype

integer

Maateenheden
  • beats/min
beats/min
2 hours Post-Dose (Reading 2) Blood pressure after erect for 1 minute (systolic)
Beschrijving

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

Datatype

integer

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

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

Datatype

integer

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

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

Datatype

integer

Maateenheden
  • beats/min
beats/min

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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