ID

35477

Description

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). 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. 3/6/19 3/6/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 6, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

English

Baseline Evening Visit

1 forms  
  1. StudyEvent: ODM
    1. Baseline Evening Visit
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Description

Study Coordinating Center, Identification number

Data type

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Description

Person Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Orthostatic Vital Signs
Description

Orthostatic Vital Signs

Alias
UMLS CUI-1
C1827287
Relative Time
Description

Taking orthostatic vital signs, Relative Time

Data type

text

Alias
UMLS CUI [1,1]
C1827287
UMLS CUI [1,2]
C0439564
After 10 minutes semi-supine - Time Vitals Taken
Description

Semi-erect; Vital Signs Time

Data type

time

Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C2826762
After 10 minutes semi-supine - Blood Pressure (systolic)
Description

Semi-erect; Systolic Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0871470
mmHg
After 10 minutes semi-supine - Blood Pressure (diastolic)
Description

Semi-erect; Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
mmHg
After 10 minutes semi-supine - Pulse
Description

Semi-erect; Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
bpm
After erect for 1 minute - Time Vitals Taken
Description

Erect, Vital Signs Time

Data type

time

Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C2826762
After erect for 1 minute - Blood Pressure (systolic)
Description

Erect, Systolic Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
mmHg
After erect for 1 minute - Blood Pressure (diastolic)
Description

Erect, Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
mmHg
After erect for 1 minute - Pulse
Description

Erect, Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
bpm
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Similar models

Baseline Evening Visit

1 forms
  1. StudyEvent: ODM
    1. Baseline Evening Visit
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Patient Number
integer
C2348585 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Orthostatic Vital Signs
C1827287 (UMLS CUI-1)
Item
Relative Time
text
C1827287 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Taking orthostatic vital signs, Relative Time
Code List
Relative Time
CL Item
Pre-Dose Reading 1 (1)
CL Item
Pre-Dose Reading 2 (2)
CL Item
Pre-Dose Reading 3 (3)
CL Item
Time of Dose (4)
CL Item
2 hours Post-Dose Reading 1 (5)
CL Item
Repeat (6)
CL Item
Repeat (7)
CL Item
Repeat (8)
CL Item
Repeat (9)
CL Item
Repeat (10)
Semi-erect; Vital Signs Time
Item
After 10 minutes semi-supine - Time Vitals Taken
time
C0522019 (UMLS CUI [1,1])
C2826762 (UMLS CUI [1,2])
Semi-erect; Systolic Pressure
Item
After 10 minutes semi-supine - Blood Pressure (systolic)
integer
C0522019 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Semi-erect; Diastolic blood pressure
Item
After 10 minutes semi-supine - Blood Pressure (diastolic)
integer
C0522019 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Semi-erect; Heart rate
Item
After 10 minutes semi-supine - Pulse
integer
C0522019 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Erect, Vital Signs Time
Item
After erect for 1 minute - Time Vitals Taken
time
C0522014 (UMLS CUI [1,1])
C2826762 (UMLS CUI [1,2])
Erect, Systolic Pressure
Item
After erect for 1 minute - Blood Pressure (systolic)
integer
C0522014 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Erect, Diastolic blood pressure
Item
After erect for 1 minute - Blood Pressure (diastolic)
integer
C0522014 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Erect, Heart rate
Item
After erect for 1 minute - Pulse
integer
C0522014 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
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