ID
24333
Beschrijving
ONLY TO BE COMPLETED IF THE PATIENT IS WITHDRAWN Part 1 of EW1/ FU1: Early Withdrawal and Follow-up 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension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
Trefwoorden
Versies (1)
- 30-07-17 30-07-17 -
Houder van rechten
glaxoSmithKline
Geüploaded op
30 juli 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1
GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1
Beschrijving
RLS Rating scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0035258
Beschrijving
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
weight in kg
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439209
Beschrijving
Weight in lbs
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439219
Beschrijving
Weight
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
after 5min sitting
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
after 5 minutes sitting
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beschrijving
after 5 minutes sitting
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beschrijving
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Beschrijving
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Adverse reaction
Alias
- UMLS CUI-1
- C0559546
Beschrijving
Patient rated scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C1578483
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C0035258
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1]
- C3640521
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1,1]
- C0349674
- UMLS CUI [1,2]
- C0037313
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1]
- C3639722
Beschrijving
Healthcare resource utilisation - visits/contacts with physician
Alias
- UMLS CUI-1
- C0031831
- UMLS CUI-2
- C0545082
Beschrijving
DO NOT INCLUDE ANY WHILE IN HOSPITAL. If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0031831
- UMLS CUI [1,2]
- C0545082
Beschrijving
Healthcare resource utilisation - visits/contacts with physician
Alias
- UMLS CUI-1
- C0031831
- UMLS CUI-2
- C0545082
Beschrijving
date of visit physician
Datatype
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0031831
Beschrijving
Type of physician
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031831
- UMLS CUI [1,2]
- C0332307
Beschrijving
Visit location
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0450429
Beschrijving
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).
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beschrijving
tests or procedures during visit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0039593
- UMLS CUI [2,1]
- C0545082
- UMLS CUI [2,2]
- C3274430
Beschrijving
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Alias
- UMLS CUI-1
- C0030450
- UMLS CUI-2
- C0545082
Beschrijving
If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
Datatype
text
Alias
- UMLS CUI [1,1]
- C0030450
- UMLS CUI [1,2]
- C0545082
Beschrijving
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Alias
- UMLS CUI-1
- C0030450
- UMLS CUI-2
- C0545082
Beschrijving
date of visit paramedical practitioner
Datatype
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0030450
Beschrijving
Type of paramedical practitioner
Datatype
integer
Alias
- UMLS CUI [1]
- C0030450
Beschrijving
Visit location
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0450429
Beschrijving
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).
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beschrijving
Healthcare resource utilisation - Hospitalisation
Alias
- UMLS CUI-1
- C0019993
Beschrijving
Healthcare resource utilisation - hospitalisation
Alias
- UMLS CUI-1
- C0019993
Beschrijving
date of admission
Datatype
date
Alias
- UMLS CUI [1]
- C1302393
Beschrijving
date of discharge
Datatype
date
Alias
- UMLS CUI [1]
- C2361123
Beschrijving
Hospitalisation cause
Datatype
text
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0392360
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beschrijving
type of ward
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1305702
- UMLS CUI [1,2]
- C0332307
Beschrijving
in days
Datatype
durationDatetime
Maateenheden
- days
Alias
- UMLS CUI [1,1]
- C1305702
- UMLS CUI [1,2]
- C0023303
Beschrijving
Healthcare resource utilisation - accident & emergency / emergency room visits
Alias
- UMLS CUI-1
- C0562508
- UMLS CUI-2
- C0545082
Beschrijving
Healthcare resource utilisation - accident & emergency / emergency room visits
Alias
- UMLS CUI-1
- C0562508
- UMLS CUI-2
- C0545082
Beschrijving
Date of visit in A&E
Datatype
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0562508
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beschrijving
Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Please take a blood sample for routine analysis.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschrijving
Laboratory label
Datatype
text
Alias
- UMLS CUI [1]
- C4273937
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1704258
Beschrijving
Urine dipstick
Alias
- UMLS CUI-1
- C0430370
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beschrijving
Pregnancy dipstick
Alias
- UMLS CUI-1
- C0430056
Beschrijving
If ’Yes’, please perform a pregnancy dipstick test and record result below.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1960468
Beschrijving
Only answer if the patient is a female of child bearing potential. If ’Positive’, please record details on the Pregnancy Notification Form
Datatype
integer
Alias
- UMLS CUI [1]
- C0427777
Beschrijving
Clinical global impression
Alias
- UMLS CUI-1
- C3639708
Beschrijving
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Beschrijving
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Beschrijving
If 'No' please mark the primary cause of withdrawal.
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348577
Beschrijving
Reason for not completing the study
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0566251
Beschrijving
Only answer, if you chose 'other' reason for not completing the study.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Beschrijving
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator signature date
Datatype
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])