ID
24326
Descripción
Module 9B: Wk 36 to Cont/Wthd 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
Palabras clave
Versiones (1)
- 30/7/17 30/7/17 -
Titular de derechos de autor
glaxoSmithKline
Subido en
30 de julio de 2017
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Week 48
GSK study: Ropinirole in RLS patients 101468/243 - Week 48
- StudyEvent: ODM
Descripción
RLS Rating scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0035258
Descripción
Vital signs
Alias
- UMLS CUI-1
- C0518766
Descripción
after 5min sitting
Tipo de datos
integer
Unidades de medida
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Descripción
after 5 minutes sitting
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Descripción
after 5 minutes sitting
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Descripción
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Descripción
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Descripción
Adverse reaction
Alias
- UMLS CUI-1
- C0559546
Descripción
Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience section at the back of this module
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0559546
Descripción
Patient rated scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C1578483
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C0035258
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3640521
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0349674
- UMLS CUI [1,2]
- C0037313
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3639722
Descripción
Healthcare resource utilisation - visits/contacts with physician
Alias
- UMLS CUI-1
- C0031831
- UMLS CUI-2
- C0545082
Descripción
DO NOT INCLUDE ANY WHILE IN HOSPITAL. If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0031831
- UMLS CUI [1,2]
- C0545082
Descripción
Healthcare resource utilisation - visits/contacts with physician
Alias
- UMLS CUI-1
- C0031831
- UMLS CUI-2
- C0545082
Descripción
date of visit physician
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0031831
Descripción
Type of physician
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0031831
- UMLS CUI [1,2]
- C0332307
Descripción
Visit location
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0450429
Descripción
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).
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Descripción
tests or procedures during visit
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0039593
- UMLS CUI [2,1]
- C0545082
- UMLS CUI [2,2]
- C3274430
Descripción
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Alias
- UMLS CUI-1
- C0030450
- UMLS CUI-2
- C0545082
Descripción
If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0030450
- UMLS CUI [1,2]
- C0545082
Descripción
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Alias
- UMLS CUI-1
- C0030450
- UMLS CUI-2
- C0545082
Descripción
date of visit paramedical practitioner
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0030450
Descripción
Type of paramedical practitioner
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0030450
Descripción
Visit location
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0450429
Descripción
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).
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Descripción
Healthcare resource utilisation - Hospitalisation
Alias
- UMLS CUI-1
- C0019993
Descripción
Healthcare resource utilisation - hospitalisation
Alias
- UMLS CUI-1
- C0019993
Descripción
date of admission
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302393
Descripción
date of discharge
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2361123
Descripción
Hospitalisation cause
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0392360
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Descripción
type of ward
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1305702
- UMLS CUI [1,2]
- C0332307
Descripción
in days
Tipo de datos
durationDatetime
Unidades de medida
- days
Alias
- UMLS CUI [1,1]
- C1305702
- UMLS CUI [1,2]
- C0023303
Descripción
Healthcare resource utilisation - accident & emergency / emergency room visits
Alias
- UMLS CUI-1
- C0562508
- UMLS CUI-2
- C0545082
Descripción
Healthcare resource utilisation - accident & emergency / emergency room visits
Alias
- UMLS CUI-1
- C0562508
- UMLS CUI-2
- C0545082
Descripción
Date of visit in A&E
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0562508
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Descripción
Clinical global impression
Alias
- UMLS CUI-1
- C3639708
Descripción
Instructions for the investigator
Alias
- UMLS CUI-1
- C0302828
- UMLS CUI-2
- C0035173
Descripción
Dispense Weeks 25 - 36 study medication, complete the Study Medication and Compliance Section at the back of the next module. If the patient’s dose has been increased at this clinic visit: a) Instruct the patient to return to the clinic this evening or remain to perform orthostatic vital signs*: - 2 sets of pre-dose orthostatic blood pressure and pulse - Patient takes evening dose in the clinic - One set of 2 hour post-dose orthostatic blood pressure and pulse Instruct the patient to take the appropriate number of tablet(s), at the same time, no earlier than 3 hours prior to and no later than one hour prior to bedtime (except on the first night of each new dose increase). Patient must return the bottle(s) with any unused medication at the next visit. Arrange for the patient to return in 84 days (plus or minus 3 days) for the Week 36 clinic visit. * Where possible this visit should be performed in the evening with dosing approximately 8:00 P.M. However, for scheduling convenience, this visit (including dosing) may occur during the afternoon hours (as late in the day as possible) to accomodate the collection of orthostatic blood pressure/pulse assessments during the normal clinic hours.
Tipo de datos
text
Descripción
Clinical Global impression
Alias
- UMLS CUI-1
- C3639708
Descripción
Dose change between scheduled visits
Alias
- UMLS CUI-1
- C1707811
Descripción
Study medication and compliance record
Alias
- UMLS CUI-1
- C2734539
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C1321605
Descripción
Specify 1 - 8
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0178602
Descripción
First Dose Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C3173309
Descripción
Date last dose
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1762893
Descripción
Number of tablets dispensed
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0304229
Descripción
Number of tablets returned
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0304229
Descripción
Dose changes
Alias
- UMLS CUI-1
- C1707811
Descripción
Study Medication Week number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439230
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0008972
Descripción
Specify 1 - 8
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0178602
Descripción
First Dose Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C3173309
Descripción
Date last dose
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1762893
Descripción
Number of tablets dispensed
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0304229
Descripción
Number of tablets returned
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0304229
Descripción
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Descripción
If 'Yes', please record details below using standard medical terminology
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0199171
- UMLS CUI [2]
- C0087111
- UMLS CUI [3]
- C0430022
- UMLS CUI [4]
- C0543467
Descripción
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Descripción
Procedure
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0199171
Descripción
All indications for procedures should be recorded in either the Adverse Experiences and/or SAE sections as appropriate.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C3146298
Descripción
Procedure Start Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0808070
Descripción
End Date Procedure
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0806020
Descripción
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Descripción
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Descripción
Drug name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013227
Descripción
eg. 500 mg
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2348070
Descripción
Any new medical illness/diagnosis (or symptoms in the absence of a diagnosis) should be recorded in the Adverse Experiences and/or SAE sections as appropriate using the same terminology.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011900
Descripción
start date of medication
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Descripción
End Date of medication
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Descripción
If a medication was marked ‘Continuing’ at a previous visit, but has since had a dosage change or has been stopped, it must be recorded as a change below with the new start and end date.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0521116
Descripción
Adverse experience (non-serious)
Alias
- UMLS CUI-1
- C1518404
Descripción
Record any adverse experiences (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way since starting the treatment or since the last visit?” Provide the diagnosis, not symptoms, where possible. One adverse experience per column. If you consider this to be a serious adverse experience (SAE), please do not enter on this page but enter in the Serious Adverse Experience (SAE) section (See opposite for definitions of an SAE).
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1518404
Descripción
Adverse experience (non-serious)
Alias
- UMLS CUI-1
- C1518404
Descripción
Record any adverse experiences (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way since starting the treatment or since the last visit?” Provide the diagnosis, not symptoms, where possible. One adverse experience per column.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1518404
Descripción
Adverse Event Start Date Time
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2826806
Descripción
(If ongoing please leave blank)
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2826793
Descripción
If patient died, STOP: go to SAE section and follow instructions given there
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1705586
Descripción
adverse event course
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Descripción
only answer if previous answer was 'intermittent'
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Descripción
Intensity concerning the maximum
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Descripción
Action Taken with Respect to Investigational Drug
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2826626
Descripción
Relationship to Investigational Drug
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descripción
f ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Descripción
Was patient withdrawn due to this specific AE?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Descripción
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Descripción
Patient continuation/ withdrawal
Alias
- UMLS CUI-1
- C2348568
Descripción
If ’No’, please mark the primary cause of withdrawal.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0549178
Descripción
Cause of withdrawal from study
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0085978
Descripción
Other cause of withdrawal from study
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0205394
Descripción
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator signature date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
GSK study: Ropinirole in RLS patients 101468/243 - Week 48
- StudyEvent: ODM
C0008972 (UMLS CUI-2)
C0008972 (UMLS CUI [1,2])
C0035258 (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])
C0035173 (UMLS CUI-2)
C0008972 (UMLS CUI-2)
C1321605 (UMLS CUI-3)
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
C0430022 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C3146298 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])