ID

24457

Description

Module 21- GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Unscheduled Week Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 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

Keywords

Versions (1)
  1. 8/1/17 8/1/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

August 1, 2017

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License

Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Unscheduled Week 2

English

GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Unscheduled Week 2

1 forms  
Study medication record since last visit
Description

Study medication record since last visit

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
Study medication record since last visit
Description

Please complete the study medication record in the Study Medication and Compliance Section.

Data type

text

Alias
UMLS CUI [1,1]
C2734539
UMLS CUI [1,2]
C0008972
Medical procedures
Description

Medical procedures

Alias
UMLS CUI-1
C0199171
Medical Procedures
Description

Please record any medical procedures performed since the last visit in the Medical Procedures section.

Data type

text

Alias
UMLS CUI [1]
C0199171
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Concomitant Medication
Description

lease record any changes in concomitant medication since the last visit in the Concomitant Medication section.

Data type

text

Alias
UMLS CUI [1]
C2347852
Adverse experience
Description

Adverse experience

Alias
UMLS CUI-1
C0559546
Adverse experience
Description

Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section.

Data type

text

Alias
UMLS CUI [1]
C0559546
Instructions for the investigator
Description

Instructions for the investigator

Alias
UMLS CUI-1
C0302828
UMLS CUI-2
C0035173
Instructions for the investigator
Description

Guided by the CGI Efficacy Index (below) determine dose level of study medication to be dispensed. Complete the Study Medication and Compliance Section. If the patient’s dose has been increased at this clinic visit: a) Instruct the patient to return to the clinic this evening or remain to perform orthostatic vital signs*: - 2 sets of pre-dose orthostatic blood pressure and pulse - Patient takes evening dose in the clinic - One set of 2 hour post-dose orthostatic blood pressure and pulse Instruct the patient to take the appropriate number of tablet(s), at the same time, no earlier than 3 hours prior to and no later than one hour prior to bedtime (except on the first night of each new dose increase). Patient must return the bottle(s) with any unused medication at the next visit. Arrange for the patient to return for next scheduled clinic visit. * Where possible this visit should be performed in the evening with dosing approximately 8:00 P.M. However, for scheduling convenience, this visit (including dosing) may occur during the afternoon hours (as late in the day as possible) to accomodate the collection of orthostatic blood pressure/pulse assessments during the normal clinic hours.

Data type

text

Alias
UMLS CUI [1,1]
C0302828
UMLS CUI [1,2]
C0035173
Clinical Global impression
Description

Clinical Global impression

Alias
UMLS CUI-1
C3639708
Clinical global impression
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

text

Alias
UMLS CUI [1]
C3639708
Dose change between scheduled visits
Description

Dose change between scheduled visits

Alias
UMLS CUI-1
C1707811
Dose change between scheduled visits
Description

If the patient requires a dose change between this and the next visit please complete Dose Changes pages.

Data type

text

Alias
UMLS CUI [1]
C1707811
Orthostatic vital signs - instructions
Description

Orthostatic vital signs - instructions

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1442085
Orthostatic vital signs - instructions
Description

ONLY TAKE ORTHOSTATIC VITAL SIGNS IF A DOSE INCREASE OCCURS Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 minutes and erect measurements will be taken after the patient has been standing for a period of 1 minute. • The blood pressure cuff must be placed on the same arm throughout the study. • Ideally, the same study nurse/medical professional should conduct all the blood pressure/pulse measurements for each clinic visit and each patient throughout the study. • Pre-dose orthostatic measurements will commence approximately 30 minutes prior to dosing and each set will be separated by 10 minutes rest in the semi-supine position. • Two sets of stable, consecutive pre-dose semi-supine and erect blood pressure measurements as well as two sets of pulse rate measurements will be taken. Stable is defined as three measurements within +15mmHg of the lowest measurement. • One set of orthostatic blood pressure and pulse measurements will be taken 2 hours post dose.

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1442085
Pre-Dose Reading
Description

Pre-Dose Reading

Alias
UMLS CUI-1
C1522609
UMLS CUI-2
C0439565
Pre-dose reading
Description

Pre-dose reading

Data type

integer

Alias
UMLS CUI [1,1]
C1522609
UMLS CUI [1,2]
C0439565
Time vitals taken
Description

Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Semi-supine systolic blood pressure
Description

Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-supine diastolic blood pressure
Description

Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Description

Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Time vitals taken
Description

Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Erect systolic blood pressure
Description

Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Erect diastolic blood pressure
Description

Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Description

Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Time of dose
Description

Time of dose

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0040223
Time of dose
Description

Time of dose

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Hr : Min
Dose level
Description

Dose level

Data type

text

Alias
UMLS CUI [1]
C0178602
2 hours Post-Dose Reading 1
Description

2 hours Post-Dose Reading 1

Alias
UMLS CUI-1
C1522609
UMLS CUI-2
C0439572
Time vitals taken
Description

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Semi-supine systolic blood pressure
Description

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-supine diastolic blood pressure
Description

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Pulse
Description

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Time vitals taken
Description

Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

Data type

time

Erect systolic blood pressure
Description

Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose. in mmHg; systolic/diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Erect diastolic blood-pressure
Description

Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Description

Pre-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
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Similar models

GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Unscheduled Week 2

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study medication record since last visit
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Study medication record since last visit
Item
Study medication record since last visit
text
C2734539 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Item Group
Medical procedures
C0199171 (UMLS CUI-1)
Medical Procedures
Item
Medical Procedures
text
C0199171 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Concomitant Medication
text
C2347852 (UMLS CUI [1])
Item Group
Adverse experience
C0559546 (UMLS CUI-1)
Adverse reaction
Item
Adverse experience
text
C0559546 (UMLS CUI [1])
Item Group
Instructions for the investigator
C0302828 (UMLS CUI-1)
C0035173 (UMLS CUI-2)
Instructions for the investigator
Item
Instructions for the investigator
text
C0302828 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
Item Group
Clinical Global impression
C3639708 (UMLS CUI-1)
Clinical global impression
Item
Clinical global impression
text
C3639708 (UMLS CUI [1])
Item Group
Dose change between scheduled visits
C1707811 (UMLS CUI-1)
Dose modification
Item
Dose change between scheduled visits
text
C1707811 (UMLS CUI [1])
Item Group
Orthostatic vital signs - instructions
C0518766 (UMLS CUI-1)
C1442085 (UMLS CUI-2)
Orthostatic vital signs - instructions
Item
Orthostatic vital signs - instructions
text
C0518766 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Item Group
Pre-Dose Reading
C1522609 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Pre-dose reading
Item
Pre-dose reading
integer
C1522609 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Semi-supine Systolic blood pressure
Item
Semi-supine systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Semi-supine diastolic blood pressure
Item
Semi-supine diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Erect systolic blood pressure
Item
Erect systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Erect diastolic blood pressure
Item
Erect diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item Group
Time of dose
C0013227 (UMLS CUI-1)
C0040223 (UMLS CUI-2)
Time of dose
Item
Time of dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dose level
Item
Dose level
text
C0178602 (UMLS CUI [1])
Item Group
2 hours Post-Dose Reading 1
C1522609 (UMLS CUI-1)
C0439572 (UMLS CUI-2)
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Semi-supine systolic blood pressure
Item
Semi-supine systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Semi-supine diastolic blood pressure
Item
Semi-supine diastolic blood pressure
integer
C0871470 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Time vitals taken
Item
Time vitals taken
time
Erect systolic blood pressure
Item
Erect systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Erect diastolic blood-pressure
Item
Erect diastolic blood-pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
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