ID

35124

Description

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 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. 2/18/19 2/18/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 18, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

English

Week 12/ Early Withdrawal - Vital Signs; Rebound Question; Follow-Up - Vital Signs; Subject's Food Intake

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Week 12/ Early Withdrawal - Vital Signs
Description

Week 12/ Early Withdrawal - Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

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

Subject position

Data type

integer

Alias
UMLS CUI [1]
C1262869
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Rebound Question
Description

Rebound Question

Alias
UMLS CUI-1
C0549262
UMLS CUI-2
C1522634
During the last week of treatment, has the subject experienced symptoms of rebound the morning after taking their dose of investigational product (i.e., rebound defined as a re-emergence of RLS symptoms in the early morning the day after taking the dose of RLS medication)?
Description

If Yes, record in the Adverse Event section of the CRF.

Data type

boolean

Alias
UMLS CUI [1,1]
C0549262
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0035258
Follow-Up - Vital Signs
Description

Follow-Up - Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

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

Subject position

Data type

integer

Alias
UMLS CUI [1]
C1262869
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Subject's Food Intake
Description

Subject's Food Intake

Alias
UMLS CUI-1
C0518037
Date and time of finishing last meal prior to the Follow-Up Visit:
Description

Note: ECG measures should be taken two or more hours after a meal.

Data type

datetime

Alias
UMLS CUI [1]
C0578574
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Similar models

Week 12/ Early Withdrawal - Vital Signs; Rebound Question; Follow-Up - Vital Signs; Subject's Food Intake

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Week 12/ Early Withdrawal - Vital Signs
C0518766 (UMLS CUI-1)
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1])
Subject position
Code List
Subject position
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
CL Item
Semi-supine (4)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Rebound Question
C0549262 (UMLS CUI-1)
C1522634 (UMLS CUI-2)
During the last week of treatment, has the subject experienced symptoms of rebound the morning after taking their dose of investigational product
Item
During the last week of treatment, has the subject experienced symptoms of rebound the morning after taking their dose of investigational product (i.e., rebound defined as a re-emergence of RLS symptoms in the early morning the day after taking the dose of RLS medication)?
boolean
C0549262 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,4])
Item Group
Follow-Up - Vital Signs
C0518766 (UMLS CUI-1)
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1])
Subject position
Code List
Subject position
CL Item
Supine  (1)
CL Item
Sitting  (2)
CL Item
Standing  (3)
CL Item
Semi-supine (4)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Subject's Food Intake
C0518037 (UMLS CUI-1)
Date and time of finishing last meal prior to the Follow-Up Visit:
Item
Date and time of finishing last meal prior to the Follow-Up Visit:
datetime
C0578574 (UMLS CUI [1])
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