ID

24455

Description

Module 19B - GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Week 48 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, Week 48

English

GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Week 48

1 forms  
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, Week 48

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