ID

40741

Description

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Keywords

Versions (3)
  1. 5/6/20 5/6/20 -
  2. 5/6/20 5/6/20 -
  3. 5/8/20 5/8/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 6, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

English

Vital Signs

1 forms  
  1. StudyEvent: ODM
    1. Vital Signs
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Vital Signs - Pre-Dose
Description

Vital Signs - Pre-Dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
Vital Signs - Date and Time
Description

Vital Signs - Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Vital Signs - Semi-supine BP Systolic
Description

Vital Signs - Semi-supine BP Systolic

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0522019
mm[Hg]
Vital Signs - Semi-supine BP Diastolic
Description

Vital Signs - Semi-supine BP Diastolic

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0522019
mm[Hg]
Vital Signs - Semi-supine Hear Rate
Description

Vital Signs - Semi-supine Hear Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522019
beats/min
Vital Signs - Time
Description

Vital Signs - Time

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Vital Signs - Erect BP Systolic
Description

Vital Signs - Erect BP Systolic

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0522014
mm[Hg]
Vital Signs - Erect BP Diastolic
Description

Vital Signs - Erect BP Diastolic

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0522014
mm[Hg]
Vital Signs - Erect Heart Rate
Description

Vital Signs - Erect Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522014
beats/min
Vital Signs - Pre-Dose (Mean)
Description

Vital Signs - Pre-Dose (Mean)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
UMLS CUI-3
C0444504
Vital Signs - Semi-supine BP Systolic (Mean)
Description

Vital Signs - Semi-supine BP Systolic (Mean)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0522019
UMLS CUI [3]
C0444504
mm[Hg]
Vital Signs - Semi-supine BP Diastolic (Mean)
Description

Vital Signs - Semi-supine BP Diastolic (Mean)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0522019
UMLS CUI [3]
C0444504
mm[Hg]
Vital Signs - Semi-supine Hear Rate (Mean)
Description

Vital Signs - Semi-supine Hear Rate (Mean)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522019
UMLS CUI [3]
C0444504
beats/min
Vital Signs - Erect BP Systolic (Mean)
Description

Vital Signs - Erect BP Systolic (Mean)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0522014
UMLS CUI [3]
C0444504
mm[Hg]
Vital Signs - Erect BP Diastolic (Mean)
Description

Vital Signs - Erect BP Diastolic (Mean)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0522014
UMLS CUI [3]
C0444504
mm[Hg]
Vital Signs - Erect Heart Rate (Mean)
Description

Vital Signs - Erect Heart Rate (Mean)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0522014
UMLS CUI [3]
C0444504
beats/min
Vital Signs Post-Dose
Description

Vital Signs Post-Dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
Vital Signs (Post-Dose) - Study Time
Description

Vital Signs (Post-Dose) - Study Time

Data type

integer

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2,1]
C0439568
UMLS CUI [2,2]
C0040223
Vital Signs (Post-Dose) - Date and Time
Description

Vital Signs (Post-Dose) - Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0011008
UMLS CUI [3,2]
C0040223
Vital Signs (Post-Dose) - Semi-supine systolic blood pressure
Description

Vital Signs (Post-Dose) - Semi-supine systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0871470
UMLS CUI [3,2]
C0522019
mm[Hg]
Vital Signs (Post-Dose) - Semi-supine diastolic blood pressure
Description

Vital Signs (Post-Dose) - Semi-supine diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C0522019
mm[Hg]
Vital Signs (Post-Dose) - Semi-supine heart rate
Description

Vital Signs (Post-Dose) - Semi-supine heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0018810
UMLS CUI [3,2]
C0522019
beats/min
Vital Signs (Post-Dose) - Time
Description

Vital Signs (Post-Dose) - Time

Data type

time

Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3]
C0040223
Vital Signs (Post-Dose) - Erect systolic blood pressure
Description

Vital Signs (Post-Dose) - Erect systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0871470
UMLS CUI [3,2]
C0522014
mm[Hg]
Vital Signs (Post-Dose) - Erect diastolic blood pressure
Description

Vital Signs (Post-Dose) - Erect diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C0522014
mm[Hg]
Vital Signs (Post-Dose) - Erect heart rate
Description

Vital Signs (Post-Dose) - Erect heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0518766
UMLS CUI [2]
C0439568
UMLS CUI [3,1]
C0018810
UMLS CUI [3,2]
C0522014
beats/min
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Similar models

Vital Signs

1 forms
  1. StudyEvent: ODM
    1. Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs - Pre-Dose
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Vital Signs - Date and Time
Item
Vital Signs - Date and Time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Vital Signs - Semi-supine BP Systolic
Item
Vital Signs - Semi-supine BP Systolic
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Semi-supine BP Diastolic
Item
Vital Signs - Semi-supine BP Diastolic
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Semi-supine Hear Rate
Item
Vital Signs - Semi-supine Hear Rate
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Time
Item
Vital Signs - Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Vital Signs - Erect BP Systolic
Item
Vital Signs - Erect BP Systolic
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Vital Signs - Erect BP Diastolic
Item
Vital Signs - Erect BP Diastolic
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Vital Signs - Erect Heart Rate
Item
Vital Signs - Erect Heart Rate
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Item Group
Vital Signs - Pre-Dose (Mean)
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0444504 (UMLS CUI-3)
Vital Signs - Semi-supine BP Systolic (Mean)
Item
Vital Signs - Semi-supine BP Systolic (Mean)
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
C0444504 (UMLS CUI [3])
Vital Signs - Semi-supine BP Diastolic (Mean)
Item
Vital Signs - Semi-supine BP Diastolic (Mean)
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
C0444504 (UMLS CUI [3])
Vital Signs - Semi-supine Hear Rate (Mean)
Item
Vital Signs - Semi-supine Hear Rate (Mean)
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
C0444504 (UMLS CUI [3])
Vital Signs - Erect BP Systolic (Mean)
Item
Vital Signs - Erect BP Systolic (Mean)
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
C0444504 (UMLS CUI [3])
Vital Signs - Erect BP Diastolic (Mean)
Item
Vital Signs - Erect BP Diastolic (Mean)
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
C0444504 (UMLS CUI [3])
Vital Signs - Erect Heart Rate (Mean)
Item
Vital Signs - Erect Heart Rate (Mean)
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
C0444504 (UMLS CUI [3])
Item Group
Vital Signs Post-Dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Vital Signs (Post-Dose) - Study Time
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Vital Signs (Post-Dose) - Study Time
Code List
Vital Signs (Post-Dose) - Study Time
CL Item
+0.5 hrs (1)
CL Item
+1 hr (2)
CL Item
+1.5 hrs (3)
CL Item
+2 hrs (4)
CL Item
+3 hrs (5)
Vital Signs (Post-Dose) - Date and Time
Item
Vital Signs (Post-Dose) - Date and Time
datetime
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0011008 (UMLS CUI [3,1])
C0040223 (UMLS CUI [3,2])
Vital Signs (Post-Dose) - Semi-supine systolic blood pressure
Item
Vital Signs (Post-Dose) - Semi-supine systolic blood pressure
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0871470 (UMLS CUI [3,1])
C0522019 (UMLS CUI [3,2])
Vital Signs (Post-Dose) - Semi-supine diastolic blood pressure
Item
Vital Signs (Post-Dose) - Semi-supine diastolic blood pressure
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0428883 (UMLS CUI [3,1])
C0522019 (UMLS CUI [3,2])
Vital Signs (Post-Dose) - Semi-supine heart rate
Item
Vital Signs (Post-Dose) - Semi-supine heart rate
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0018810 (UMLS CUI [3,1])
C0522019 (UMLS CUI [3,2])
Vital Signs (Post-Dose) - Time
Item
Vital Signs (Post-Dose) - Time
time
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
Vital Signs (Post-Dose) - Erect systolic blood pressure
Item
Vital Signs (Post-Dose) - Erect systolic blood pressure
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0871470 (UMLS CUI [3,1])
C0522014 (UMLS CUI [3,2])
Vital Signs (Post-Dose) - Erect diastolic blood pressure
Item
Vital Signs (Post-Dose) - Erect diastolic blood pressure
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0428883 (UMLS CUI [3,1])
C0522014 (UMLS CUI [3,2])
Vital Signs (Post-Dose) - Erect heart rate
Item
Vital Signs (Post-Dose) - Erect heart rate
integer
C0518766 (UMLS CUI [1])
C0439568 (UMLS CUI [2])
C0018810 (UMLS CUI [3,1])
C0522014 (UMLS CUI [3,2])
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