ID

29008

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. 2/20/18 2/20/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

February 20, 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

RLS Demographics and Examination Procedure

1 forms  
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
'Other' race, please specify:
Description

If you answered the previous question with 'other', please specify:

Data type

text

Alias
UMLS CUI [1]
C0034510
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Height (without shoes)
Description

Height

Data type

integer

Measurement units
  • cm / in
Alias
UMLS CUI [1]
C0005890
cm / in
Weight (without shoes)
Description

Weight

Data type

integer

Measurement units
  • kg / lbs
Alias
UMLS CUI [1]
C0005910
kg / lbs
Pulse (after 5 minutes sitting)
Description

Pulse

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Sitting Blood Pressure (after 5 minutes sitting), systolic / diastolic
Description

Sitting Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0580946
mmHg
Orthostatic vital signs
Description

Orthostatic vital signs

Alias
UMLS CUI-1
C0518766
Screening
Description

Screening

Data type

integer

Alias
UMLS CUI [1]
C0220908
Time Vitals taken
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Blood Pressure systolic / diastolic
Description

Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse
Description

Pulse

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Electrocardiogram
Description

Electrocardiogram

Alias
UMLS CUI-1
C0430456
Date of ECG:
Description

Date of ECG

Data type

date

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

If ’Yes’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and repeat prior to baseline.

Data type

integer

Alias
UMLS CUI [1]
C0522055
Laboratory evaluation
Description

Laboratory evaluation

Alias
UMLS CUI-1
C0022885
Date of blood sample:
Description

Read the instructions on the Quest Diagnostics shipment document and dispatch the samples for analysis accordingly.

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Were any clinically significant abnormalities detected?
Description

If ’Yes’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and repeat prior to baseline.

Data type

text

Alias
UMLS CUI [1]
C1853129
Pregnancy Dipstick
Description

Pregnancy Dipstick

Alias
UMLS CUI-1
C0430056
Is the patient a female of child-bearing potential?
Description

If ’Yes’, please perform a pregnancy dipstick test and record result below.

Data type

text

Alias
UMLS CUI [1]
C1960468
Pregnancy Dipstick result
Description

If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination and exclude the patient.

Data type

text

Alias
UMLS CUI [1]
C0430056
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Similar models

RLS Demographics and Examination Procedure

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Oriental (3)
CL Item
Other (4)
Race
Item
'Other' race, please specify:
text
C0034510 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Height
Item
Height (without shoes)
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight (without shoes)
integer
C0005910 (UMLS CUI [1])
Pulse
Item
Pulse (after 5 minutes sitting)
integer
C0232117 (UMLS CUI [1])
Sitting Blood Pressure
Item
Sitting Blood Pressure (after 5 minutes sitting), systolic / diastolic
integer
C0580946 (UMLS CUI [1])
Item Group
Orthostatic vital signs
C0518766 (UMLS CUI-1)
Item
Screening
integer
C0220908 (UMLS CUI [1])
Screening
Code List
Screening
CL Item
After 10 minutes semi-supine (1)
CL Item
After erect for 1 minute (2)
Time
Item
Time Vitals taken
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure systolic / diastolic
integer
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item Group
Electrocardiogram
C0430456 (UMLS CUI-1)
Date 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 blood sample
Item
Date of blood sample:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Were any clinically significant abnormalities detected?
text
C1853129 (UMLS CUI [1])
Laboratory abnormalities
Code List
Were any clinically significant abnormalities detected?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Pregnancy Dipstick
C0430056 (UMLS CUI-1)
Item
Is the patient a female of child-bearing potential?
text
C1960468 (UMLS CUI [1])
Child-bearing potential
Code List
Is the patient a female of child-bearing potential?
CL Item
No (N)
CL Item
Yes (Y)
Item
Pregnancy Dipstick result
text
C0430056 (UMLS CUI [1])
Pregnancy Dipstick
Code List
Pregnancy Dipstick result
CL Item
Negative (NEG)
CL Item
Positive (POS)
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