ID
24333
Description
ONLY TO BE COMPLETED IF THE PATIENT IS WITHDRAWN Part 1 of EW1/ FU1: Early Withdrawal and Follow-up 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A 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)
- 7/30/17 7/30/17 -
Copyright Holder
glaxoSmithKline
Uploaded on
July 30, 2017
DOI
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License
Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1
GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1
Description
RLS Rating scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0035258
Description
Vital signs
Alias
- UMLS CUI-1
- C0518766
Description
weight in kg
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439209
Description
Weight in lbs
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439219
Description
Weight
Data type
float
Alias
- UMLS CUI [1]
- C0005910
Description
after 5min sitting
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Description
after 5 minutes sitting
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Description
after 5 minutes sitting
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Description
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Adverse reaction
Alias
- UMLS CUI-1
- C0559546
Description
Patient rated scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C1578483
Description
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: 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 • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Data type
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C0035258
Description
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: 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 • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Data type
text
Alias
- UMLS CUI [1]
- C3640521
Description
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: 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 • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Data type
text
Alias
- UMLS CUI [1,1]
- C0349674
- UMLS CUI [1,2]
- C0037313
Description
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: 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 • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Data type
text
Alias
- UMLS CUI [1]
- C3639722
Description
Healthcare resource utilisation - visits/contacts with physician
Alias
- UMLS CUI-1
- C0031831
- UMLS CUI-2
- C0545082
Description
DO NOT INCLUDE ANY WHILE IN HOSPITAL. If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0031831
- UMLS CUI [1,2]
- C0545082
Description
Healthcare resource utilisation - visits/contacts with physician
Alias
- UMLS CUI-1
- C0031831
- UMLS CUI-2
- C0545082
Description
date of visit physician
Data type
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0031831
Description
Type of physician
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031831
- UMLS CUI [1,2]
- C0332307
Description
Visit location
Data type
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0450429
Description
A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).
Data type
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Description
tests or procedures during visit
Data type
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0039593
- UMLS CUI [2,1]
- C0545082
- UMLS CUI [2,2]
- C3274430
Description
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Alias
- UMLS CUI-1
- C0030450
- UMLS CUI-2
- C0545082
Description
If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
Data type
text
Alias
- UMLS CUI [1,1]
- C0030450
- UMLS CUI [1,2]
- C0545082
Description
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Alias
- UMLS CUI-1
- C0030450
- UMLS CUI-2
- C0545082
Description
date of visit paramedical practitioner
Data type
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0030450
Description
Type of paramedical practitioner
Data type
integer
Alias
- UMLS CUI [1]
- C0030450
Description
Visit location
Data type
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0450429
Description
A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).
Data type
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Description
Healthcare resource utilisation - Hospitalisation
Alias
- UMLS CUI-1
- C0019993
Description
Healthcare resource utilisation - hospitalisation
Alias
- UMLS CUI-1
- C0019993
Description
date of admission
Data type
date
Alias
- UMLS CUI [1]
- C1302393
Description
date of discharge
Data type
date
Alias
- UMLS CUI [1]
- C2361123
Description
Hospitalisation cause
Data type
text
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0392360
Description
A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.
Data type
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Description
type of ward
Data type
integer
Alias
- UMLS CUI [1,1]
- C1305702
- UMLS CUI [1,2]
- C0332307
Description
in days
Data type
durationDatetime
Measurement units
- days
Alias
- UMLS CUI [1,1]
- C1305702
- UMLS CUI [1,2]
- C0023303
Description
Healthcare resource utilisation - accident & emergency / emergency room visits
Alias
- UMLS CUI-1
- C0562508
- UMLS CUI-2
- C0545082
Description
Healthcare resource utilisation - accident & emergency / emergency room visits
Alias
- UMLS CUI-1
- C0562508
- UMLS CUI-2
- C0545082
Description
Date of visit in A&E
Data type
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0562508
Description
A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.
Data type
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Description
Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
Description
Please take a blood sample for routine analysis.
Data type
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Description
Laboratory label
Data type
text
Alias
- UMLS CUI [1]
- C4273937
Description
If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this module, send a sample to Quest Diagnostics for further evaluation.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1704258
Description
Urine dipstick
Alias
- UMLS CUI-1
- C0430370
Description
Please perform a urine dipstick test for presence of blood or protein. If ’Positive’, please record details in the Adverse Experiences and/or SAE Section at the back of this module, send a sample to Quest Diagnostics for further evaluation.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Description
Pregnancy dipstick
Alias
- UMLS CUI-1
- C0430056
Description
If ’Yes’, please perform a pregnancy dipstick test and record result below.
Data type
boolean
Alias
- UMLS CUI [1]
- C1960468
Description
Only answer if the patient is a female of child bearing potential. If ’Positive’, please record details on the Pregnancy Notification Form
Data type
integer
Alias
- UMLS CUI [1]
- C0427777
Description
Clinical global impression
Alias
- UMLS CUI-1
- C3639708
Description
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Description
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Description
If 'No' please mark the primary cause of withdrawal.
Data type
boolean
Alias
- UMLS CUI [1]
- C2348577
Description
Reason for not completing the study
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0566251
Description
Only answer, if you chose 'other' reason for not completing the study.
Data type
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Description
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Description
I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Adverse Experience and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator signature date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1
C0008972 (UMLS CUI-2)
C0008972 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
C0439209 (UMLS CUI [1,2])
C0439219 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0034380 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0037313 (UMLS CUI [1,2])
C0545082 (UMLS CUI-2)
C0545082 (UMLS CUI [1,2])
C0545082 (UMLS CUI-2)
C0031831 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,2])
C0545082 (UMLS CUI [2,1])
C3274430 (UMLS CUI [2,2])
C0545082 (UMLS CUI-2)
C0545082 (UMLS CUI [1,2])
C0545082 (UMLS CUI-2)
C0030450 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0023303 (UMLS CUI [1,2])
C0545082 (UMLS CUI-2)
C0545082 (UMLS CUI [1,2])
C0545082 (UMLS CUI-2)
C0562508 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])