ID

29075

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

Scales, baseline signs and symptoms

1 forms  
Scales RLS
Description

Scales RLS

Alias
UMLS CUI-1
C0450973
UMLS CUI-2
C0035258
Please complete the information below based on the Baseline IRLS Rating Scale. If this score is not ≥ 15, exclude the patient
Description

IRLS Rating Scale

Data type

integer

Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale • Hospital Anxiety and Depression Scale (HADS)
Description

If the patient is eligible to continue in the study please continue the assessments for this visit as stated below:

Data type

boolean

Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
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

Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
Description

Concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Description

Medical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0199171
Baseline signs and symptoms
Description

Baseline signs and symptoms

Alias
UMLS CUI-1
C0037088
If you consider this to be a serious baseline event (SBE), please do not enter on this page but enter in the Serious Adverse Experience section (SAE) (See opposite for definitions of an SBE)
Description

Serious baseline events

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Please mark this box if no baseline events occurred prior to randomisation into study.
Description

Baseline events

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Baseline signs and symptoms
Description

Baseline signs and symptoms

Alias
UMLS CUI-1
C0037088
Onset Date and Time
Description

Onset Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C2826806
End Date and Time (If ongoing please leave blank)
Description

End Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C2826793
Outcome If patient died, STOP: go to SAE section and follow instructions given there
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Event Course
Description

Event Course

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Event Course, if 'intermittent' please specify No. of episodes:
Description

Event Course

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Intensity (maximum)
Description

INTENSITY (Maximum) MILD An event which is easily tolerated MODERATE An event which is sufficiently discomforting to interfere with daily activities SEVERE An event which prevents normal everyday activities

Data type

integer

Alias
UMLS CUI [1]
C1710066
Relationship to study procedures performed prior to randomisation
Description

RELATIONSHIP TO STUDY PROCEDURES RELATED There is a direct cause and effect relationship between the event and the study procedures POSSIBLY RELATED A direct cause and effect relationship between the study procedures and the event has not been demonstrated but is possible or likely PROBABLY UNRELATED Cause and effect relationship between the study procedures and the event has not been demonstrated, is improbable but not impossible UNRELATED The event is definitely not related to the study procedures

Data type

integer

Alias
UMLS CUI [1]
C1510821
Corrective Therapy
Description

If ‘Yes’, record details in Prior and Concomitant Medication section and/or Health Care Resource Utilisation section if appropriate.

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific event?
Description

Withdrawal related to adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
Ramos Randomisation and Dispensing
Description

Ramos Randomisation and Dispensing

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0947323
Randomisation number:
Description

Randomisation number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Container numbers:
Description

Container numbers

Data type

integer

Alias
UMLS CUI [1]
C0180098
Orthostatic vital signs
Description

Orthostatic vital signs

Alias
UMLS CUI-1
C0518766
Orthostatic vital signs
Description

Orthostatic vital signs

Data type

integer

Alias
UMLS CUI [1]
C0518766
Reading
Description

Reading

Data type

integer

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0034754
Time of dose
Description

Time of dose

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Time Vitals Taken
Description

Time Vitals Taken

Data type

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
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
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Similar models

Scales, baseline signs and symptoms

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Scales RLS
C0450973 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
IRLS Rating Scale
Item
Please complete the information below based on the Baseline IRLS Rating Scale. If this score is not ≥ 15, exclude the patient
integer
Patient rated scales
Item
Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale • Hospital Anxiety and Depression Scale (HADS)
boolean
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Pulse
Item
Pulse (after 5 minutes sitting)
integer
C0232117 (UMLS CUI [1])
Blood pressure
Item
Sitting Blood Pressure (after 5 minutes sitting) systolic / diastolic
integer
C0005823 (UMLS CUI [1])
Concomitant medication
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
boolean
C2347852 (UMLS CUI [1])
Medical Procedures
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
boolean
C0199171 (UMLS CUI [1])
Item Group
Baseline signs and symptoms
C0037088 (UMLS CUI-1)
Serious baseline events
Item
If you consider this to be a serious baseline event (SBE), please do not enter on this page but enter in the Serious Adverse Experience section (SAE) (See opposite for definitions of an SBE)
boolean
C1519255 (UMLS CUI [1])
Baseline events
Item
Please mark this box if no baseline events occurred prior to randomisation into study.
boolean
C0877248 (UMLS CUI [1])
Item Group
Baseline signs and symptoms
C0037088 (UMLS CUI-1)
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time (If ongoing please leave blank)
datetime
C2826793 (UMLS CUI [1])
Item
Outcome If patient died, STOP: go to SAE section and follow instructions given there
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome If patient died, STOP: go to SAE section and follow instructions given there
CL Item
[1] Resolved (1)
CL Item
[2] Ongoing (2)
CL Item
[3] Died (3)
Item
Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Event Course
Code List
Event Course
CL Item
[1] Intermittent (1)
CL Item
[2] Constant (2)
Event Course
Item
Event Course, if 'intermittent' please specify No. of episodes:
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (maximum)
CL Item
[1] Mild (1)
CL Item
[2] Moderate (2)
CL Item
[3] Severe (3)
Item
Relationship to study procedures performed prior to randomisation
integer
C1510821 (UMLS CUI [1])
Relationship to study procedures
Code List
Relationship to study procedures performed prior to randomisation
CL Item
[5] Related (1)
CL Item
[6] Possibly related (2)
CL Item
[7] Probably unrelated (3)
CL Item
[1] Unrelated (4)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Withdrawal related to adverse event
Item
Was patient withdrawn due to this specific event?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Ramos Randomisation and Dispensing
C0034656 (UMLS CUI-1)
C0947323 (UMLS CUI-2)
Randomisation number
Item
Randomisation number:
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Container numbers
Item
Container numbers:
integer
C0180098 (UMLS CUI [1])
Item Group
Orthostatic vital signs
C0518766 (UMLS CUI-1)
Item
Orthostatic vital signs
integer
C0518766 (UMLS CUI [1])
Orthostatic vital signs
Code List
Orthostatic vital signs
CL Item
After 10 minutes semi-supine (1)
CL Item
After erect for 1 minute (2)
Item
Reading
integer
C0456984 (UMLS CUI [1,1])
C0034754 (UMLS CUI [1,2])
Reading
Code List
Reading
CL Item
Pre-Dose Reading (1)
CL Item
2 hours Post-Dose Reading (2)
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Time Vitals Taken
Item
Time Vitals Taken
date
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood pressure
Item
Blood pressure systolic/diastolic
integer
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
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