ID
24321
Beschreibung
Module 6A: Wk 12 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
Stichworte
Versionen (1)
- 29.07.17 29.07.17 -
Rechteinhaber
glaxoSmithKline
Hochgeladen am
29. Juli 2017
DOI
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Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Week 12
GSK study: Ropinirole in RLS patients 101468/243 - Week 12
- StudyEvent: ODM
Beschreibung
RLS Rating scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0035258
Beschreibung
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
after 5min sitting
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschreibung
after 5 minutes sitting
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beschreibung
after 5 minutes sitting
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beschreibung
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Beschreibung
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Adverse reaction
Alias
- UMLS CUI-1
- C0559546
Beschreibung
Patient rated scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C1578483
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C0035258
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1]
- C3640521
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0349674
- UMLS CUI [1,2]
- C0037313
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1]
- C3639722
Beschreibung
Healthcare resource utilisation - visits/contacts with physician
Alias
- UMLS CUI-1
- C0031831
- UMLS CUI-2
- C0545082
Beschreibung
DO NOT INCLUDE ANY WHILE IN HOSPITAL. If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0031831
- UMLS CUI [1,2]
- C0545082
Beschreibung
Healthcare resource utilisation - visits/contacts with physician
Alias
- UMLS CUI-1
- C0031831
- UMLS CUI-2
- C0545082
Beschreibung
date of visit physician
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0031831
Beschreibung
Type of physician
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031831
- UMLS CUI [1,2]
- C0332307
Beschreibung
Visit location
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0450429
Beschreibung
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).
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beschreibung
tests or procedures during visit
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0039593
- UMLS CUI [2,1]
- C0545082
- UMLS CUI [2,2]
- C3274430
Beschreibung
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Alias
- UMLS CUI-1
- C0030450
- UMLS CUI-2
- C0545082
Beschreibung
If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0030450
- UMLS CUI [1,2]
- C0545082
Beschreibung
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Alias
- UMLS CUI-1
- C0030450
- UMLS CUI-2
- C0545082
Beschreibung
date of visit paramedical practitioner
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0030450
Beschreibung
Type of paramedical practitioner
Datentyp
integer
Alias
- UMLS CUI [1]
- C0030450
Beschreibung
Visit location
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0450429
Beschreibung
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).
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beschreibung
Healthcare resource utilisation - Hospitalisation
Alias
- UMLS CUI-1
- C0019993
Beschreibung
Healthcare resource utilisation - hospitalisation
Alias
- UMLS CUI-1
- C0019993
Beschreibung
date of admission
Datentyp
date
Alias
- UMLS CUI [1]
- C1302393
Beschreibung
date of discharge
Datentyp
date
Alias
- UMLS CUI [1]
- C2361123
Beschreibung
Hospitalisation cause
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0392360
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beschreibung
type of ward
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1305702
- UMLS CUI [1,2]
- C0332307
Beschreibung
in days
Datentyp
durationDatetime
Maßeinheiten
- days
Alias
- UMLS CUI [1,1]
- C1305702
- UMLS CUI [1,2]
- C0023303
Beschreibung
Healthcare resource utilisation - accident & emergency / emergency room visits
Alias
- UMLS CUI-1
- C0562508
- UMLS CUI-2
- C0545082
Beschreibung
Healthcare resource utilisation - accident & emergency / emergency room visits
Alias
- UMLS CUI-1
- C0562508
- UMLS CUI-2
- C0545082
Beschreibung
Date of visit in A&E
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0562508
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beschreibung
Clinical global impression
Alias
- UMLS CUI-1
- C3639708
Beschreibung
Instructions for the investigator
Alias
- UMLS CUI-1
- C0302828
- UMLS CUI-2
- C0035173
Beschreibung
Guided by the CGI Efficacy Index (below) determine dose level to be dispensed and dispense Weeks 13 - 24 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 24 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.
Datentyp
text
Beschreibung
Clinical Global impression
Alias
- UMLS CUI-1
- C3639708
Beschreibung
Dose change between scheduled visits
Alias
- UMLS CUI-1
- C1707811
Beschreibung
Study medication and compliance record
Alias
- UMLS CUI-1
- C2734539
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C1321605
Beschreibung
Specify 1 - 8
Datentyp
integer
Alias
- UMLS CUI [1]
- C0178602
Beschreibung
First Dose Date
Datentyp
date
Alias
- UMLS CUI [1]
- C3173309
Beschreibung
Date last dose
Datentyp
date
Alias
- UMLS CUI [1]
- C1762893
Beschreibung
Number of tablets dispensed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0304229
Beschreibung
Number of tablets returned
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0304229
Beschreibung
Dose changes
Alias
- UMLS CUI-1
- C1707811
Beschreibung
Study Medication Week number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439230
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0008972
Beschreibung
Specify 1 - 8
Datentyp
integer
Alias
- UMLS CUI [1]
- C0178602
Beschreibung
First Dose Date
Datentyp
date
Alias
- UMLS CUI [1]
- C3173309
Beschreibung
Date last dose
Datentyp
date
Alias
- UMLS CUI [1]
- C1762893
Beschreibung
Number of tablets dispensed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0304229
Beschreibung
Number of tablets returned
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0304229
Beschreibung
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Beschreibung
If 'Yes', please record details below using standard medical terminology
Datentyp
integer
Alias
- UMLS CUI [1]
- C0199171
- UMLS CUI [2]
- C0087111
- UMLS CUI [3]
- C0430022
- UMLS CUI [4]
- C0543467
Beschreibung
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Beschreibung
Procedure
Datentyp
text
Alias
- UMLS CUI [1]
- C0199171
Beschreibung
All indications for procedures should be recorded in either the Adverse Experiences and/or SAE sections as appropriate.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C3146298
Beschreibung
Procedure Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0808070
Beschreibung
End Date Procedure
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0806020
Beschreibung
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Drug name
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
eg. 500 mg
Datentyp
text
Alias
- UMLS CUI [1]
- C2348070
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C0011900
Beschreibung
start date of medication
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
End Date of medication
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0521116
Beschreibung
Adverse experience (non-serious)
Alias
- UMLS CUI-1
- C1518404
Beschreibung
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).
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
Adverse experience (non-serious)
Alias
- UMLS CUI-1
- C1518404
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
Adverse Event Start Date Time
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826806
Beschreibung
(If ongoing please leave blank)
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826793
Beschreibung
If patient died, STOP: go to SAE section and follow instructions given there
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
adverse event course
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschreibung
only answer if previous answer was 'intermittent'
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Beschreibung
Intensity concerning the maximum
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Beschreibung
Action Taken with Respect to Investigational Drug
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
Relationship to Investigational Drug
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
f ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschreibung
Was patient withdrawn due to this specific AE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beschreibung
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Beschreibung
Patient continuation/ withdrawal
Alias
- UMLS CUI-1
- C2348568
Beschreibung
If ’No’, please mark the primary cause of withdrawal.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0549178
Beschreibung
Cause of withdrawal from study
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0085978
Beschreibung
Other cause of withdrawal from study
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0205394
Beschreibung
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator signature date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
GSK study: Ropinirole in RLS patients 101468/243 - Week 12
- 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])