ID

25321

Description

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

Keywords

Versions (1)
  1. 9/1/17 9/1/17 -
Uploaded on

September 1, 2017

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Creative Commons BY-NC 3.0
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 6 Day -1 (Form 10)

English

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 6 Day -1 (Form 10)

1 forms  
General Information
Description

General Information

Center Number
Description

Center Number

Data type

integer

Patient Number
Description

Patient Number

Data type

integer

Patient Initials
Description

Patient Initials

Data type

text

Visit Date
Description

Visit Date

Data type

date

Orthostatic Vital Signs
Description

Orthostatic Vital Signs

Time of dose
Description

Time of dose

Data type

time

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

Measurement units
  • beats/min
beats/min
Pre-Dose (Reading 1) Blood pressure after erect for 1 minute (systolic)
Description

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

Measurement units
  • beats/min
beats/min
Pre-Dose (Reading 2) Blood pressure after 10 minutes semi-supine (systolic)
Description

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

Measurement units
  • beats/min
beats/min
Pre-Dose (Reading 2) Blood pressure after erect for 1 minute (systolic)
Description

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

integer

Measurement units
  • beats/min
beats/min
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Similar models

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 6 Day -1 (Form 10)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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