ID

35462

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. 3/5/19 3/5/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 5, 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

Screening Repeat Tests

1 forms  
  1. StudyEvent: ODM
    1. Screening Repeat Tests
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
Electrocardiogram (12 Lead)
Description

Electrocardiogram (12 Lead)

Alias
UMLS CUI-1
C0430456
Date of ECG
Description

12 lead ECG, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
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

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Laboratory Evaluation
Description

Laboratory Evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0220825
Date of sample
Description

Collection of blood specimen for laboratory procedure, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Please affix the Quest Diagnostics Laboratory label here.
Description

Laboratory Procedures, Laboratory specimen identification label

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C4273937
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

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1704258
Urine Dipstick
Description

Urine Dipstick

Alias
UMLS CUI-1
C0430370
What was the result of the urine dipstick performed at this visit?
Description

If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and send a sample to Quest Diagnostics for further evaluation.

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
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Similar models

Screening Repeat Tests

1 forms
  1. StudyEvent: ODM
    1. Screening Repeat Tests
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
Electrocardiogram (12 Lead)
C0430456 (UMLS CUI-1)
12 lead ECG, Date in time
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Abnormality
Item
Were any clinically significant abnormalities detected?
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item Group
Laboratory Evaluation
C0022885 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Collection of blood specimen for laboratory procedure, Date in time
Item
Date of sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Procedures, Laboratory specimen identification label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C0022885 (UMLS CUI [1,1])
C4273937 (UMLS CUI [1,2])
Laboratory Procedures, Abnormality
Item
Were any clinically significant abnormalities detected?
boolean
C0022885 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
Urine Dipstick
C0430370 (UMLS CUI-1)
Item
What was the result of the urine dipstick performed at this visit?
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Urine dipstick test, Test Result
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Negative (1)
CL Item
Positive (2)
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