ID
24326
Beskrivning
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
Nyckelord
Versioner (1)
- 2017-07-30 2017-07-30 -
Rättsinnehavare
glaxoSmithKline
Uppladdad den
30 juli 2017
DOI
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Licens
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
Beskrivning
RLS Rating scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0035258
Beskrivning
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
after 5min sitting
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beskrivning
after 5 minutes sitting
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beskrivning
after 5 minutes sitting
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beskrivning
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Beskrivning
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Adverse reaction
Alias
- UMLS CUI-1
- C0559546
Beskrivning
Patient rated scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C1578483
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C0035258
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1]
- C3640521
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0349674
- UMLS CUI [1,2]
- C0037313
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1]
- C3639722
Beskrivning
Healthcare resource utilisation - visits/contacts with physician
Alias
- UMLS CUI-1
- C0031831
- UMLS CUI-2
- C0545082
Beskrivning
DO NOT INCLUDE ANY WHILE IN HOSPITAL. If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0031831
- UMLS CUI [1,2]
- C0545082
Beskrivning
Healthcare resource utilisation - visits/contacts with physician
Alias
- UMLS CUI-1
- C0031831
- UMLS CUI-2
- C0545082
Beskrivning
date of visit physician
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0031831
Beskrivning
Type of physician
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031831
- UMLS CUI [1,2]
- C0332307
Beskrivning
Visit location
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0450429
Beskrivning
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).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beskrivning
tests or procedures during visit
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0039593
- UMLS CUI [2,1]
- C0545082
- UMLS CUI [2,2]
- C3274430
Beskrivning
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Alias
- UMLS CUI-1
- C0030450
- UMLS CUI-2
- C0545082
Beskrivning
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Alias
- UMLS CUI-1
- C0030450
- UMLS CUI-2
- C0545082
Beskrivning
date of visit paramedical practitioner
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0030450
Beskrivning
Type of paramedical practitioner
Datatyp
integer
Alias
- UMLS CUI [1]
- C0030450
Beskrivning
Visit location
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0450429
Beskrivning
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).
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beskrivning
Healthcare resource utilisation - Hospitalisation
Alias
- UMLS CUI-1
- C0019993
Beskrivning
Healthcare resource utilisation - hospitalisation
Alias
- UMLS CUI-1
- C0019993
Beskrivning
date of admission
Datatyp
date
Alias
- UMLS CUI [1]
- C1302393
Beskrivning
date of discharge
Datatyp
date
Alias
- UMLS CUI [1]
- C2361123
Beskrivning
Hospitalisation cause
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0392360
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beskrivning
type of ward
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1305702
- UMLS CUI [1,2]
- C0332307
Beskrivning
in days
Datatyp
durationDatetime
Måttenheter
- days
Alias
- UMLS CUI [1,1]
- C1305702
- UMLS CUI [1,2]
- C0023303
Beskrivning
Healthcare resource utilisation - accident & emergency / emergency room visits
Alias
- UMLS CUI-1
- C0562508
- UMLS CUI-2
- C0545082
Beskrivning
Healthcare resource utilisation - accident & emergency / emergency room visits
Alias
- UMLS CUI-1
- C0562508
- UMLS CUI-2
- C0545082
Beskrivning
Date of visit in A&E
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0562508
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beskrivning
Clinical global impression
Alias
- UMLS CUI-1
- C3639708
Beskrivning
Instructions for the investigator
Alias
- UMLS CUI-1
- C0302828
- UMLS CUI-2
- C0035173
Beskrivning
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.
Datatyp
text
Beskrivning
Clinical Global impression
Alias
- UMLS CUI-1
- C3639708
Beskrivning
Dose change between scheduled visits
Alias
- UMLS CUI-1
- C1707811
Beskrivning
Study medication and compliance record
Alias
- UMLS CUI-1
- C2734539
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C1321605
Beskrivning
Specify 1 - 8
Datatyp
integer
Alias
- UMLS CUI [1]
- C0178602
Beskrivning
First Dose Date
Datatyp
date
Alias
- UMLS CUI [1]
- C3173309
Beskrivning
Date last dose
Datatyp
date
Alias
- UMLS CUI [1]
- C1762893
Beskrivning
Number of tablets dispensed
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0304229
Beskrivning
Number of tablets returned
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0304229
Beskrivning
Dose changes
Alias
- UMLS CUI-1
- C1707811
Beskrivning
Study Medication Week number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439230
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0008972
Beskrivning
Specify 1 - 8
Datatyp
integer
Alias
- UMLS CUI [1]
- C0178602
Beskrivning
First Dose Date
Datatyp
date
Alias
- UMLS CUI [1]
- C3173309
Beskrivning
Date last dose
Datatyp
date
Alias
- UMLS CUI [1]
- C1762893
Beskrivning
Number of tablets dispensed
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0304229
Beskrivning
Number of tablets returned
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0304229
Beskrivning
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Beskrivning
If 'Yes', please record details below using standard medical terminology
Datatyp
integer
Alias
- UMLS CUI [1]
- C0199171
- UMLS CUI [2]
- C0087111
- UMLS CUI [3]
- C0430022
- UMLS CUI [4]
- C0543467
Beskrivning
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Beskrivning
Procedure
Datatyp
text
Alias
- UMLS CUI [1]
- C0199171
Beskrivning
All indications for procedures should be recorded in either the Adverse Experiences and/or SAE sections as appropriate.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C3146298
Beskrivning
Procedure Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0808070
Beskrivning
End Date Procedure
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0806020
Beskrivning
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Drug name
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
eg. 500 mg
Datatyp
text
Alias
- UMLS CUI [1]
- C2348070
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C0011900
Beskrivning
start date of medication
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
End Date of medication
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0521116
Beskrivning
Adverse experience (non-serious)
Alias
- UMLS CUI-1
- C1518404
Beskrivning
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).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
Adverse experience (non-serious)
Alias
- UMLS CUI-1
- C1518404
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
Adverse Event Start Date Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826806
Beskrivning
(If ongoing please leave blank)
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826793
Beskrivning
If patient died, STOP: go to SAE section and follow instructions given there
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
adverse event course
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beskrivning
only answer if previous answer was 'intermittent'
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Beskrivning
Intensity concerning the maximum
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Beskrivning
Action Taken with Respect to Investigational Drug
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beskrivning
Relationship to Investigational Drug
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
f ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beskrivning
Was patient withdrawn due to this specific AE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beskrivning
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Beskrivning
Patient continuation/ withdrawal
Alias
- UMLS CUI-1
- C2348568
Beskrivning
If ’No’, please mark the primary cause of withdrawal.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0549178
Beskrivning
Cause of withdrawal from study
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0085978
Beskrivning
Other cause of withdrawal from study
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0205394
Beskrivning
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator signature date
Datatyp
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])