ID

29073

Description

Study ID: 101468/249 Clinical Study ID: 101468/249 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: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

Keywords

Versions (1)
  1. 2/23/18 2/23/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

February 23, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857

English

Abnormal findings at the Screening Visit

1 forms  
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Patient number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Visit date
Description

Visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Center Number
Description

Center Number

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Electrocardiogram (12 lead)
Description

Electrocardiogram (12 lead)

Alias
UMLS CUI-1
C0430456
Date of ECG
Description

Dato of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Were any clinically significant abnormalities detected?
Description

If ’Yes’, please record details in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study.

Data type

integer

Alias
UMLS CUI [1]
C0522055
Laboratory evaluation
Description

Laboratory evaluation

Alias
UMLS CUI-1
C0022885
Date of sample
Description

Date of sample

Data type

date

Alias
UMLS CUI [1]
C1302413
Were any clinically significant abnormalities detected?
Description

If ‘Yes’, please record the findings and/or diagnosis in the Baseline Signs and Symptoms and/or SAE section at the back of this book and exclude the patient from the study.

Data type

integer

Alias
UMLS CUI [1]
C1853129
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Similar models

Abnormal findings at the Screening Visit

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Electrocardiogram (12 lead)
C0430456 (UMLS CUI-1)
Dato of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
integer
C0522055 (UMLS CUI [1])
ECG abnormalities
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes (2)
Item Group
Laboratory evaluation
C0022885 (UMLS CUI-1)
Date of sample
Item
Date of sample
date
C1302413 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
integer
C1853129 (UMLS CUI [1])
Laboratory abnormalities
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes (2)
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