ID
24329
Beschrijving
Part 2 of Module 12: Wk 52, Follow-Up & Study Conc 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
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Licentie
Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Follow up
GSK study: Ropinirole in RLS patients 101468/243 - Follow-up
- StudyEvent: ODM
Beschrijving
Vital signs
Alias
- UMLS CUI-1
- C0518766
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
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Adverse reaction
Alias
- UMLS CUI-1
- C0559546
Beschrijving
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Beschrijving
Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Please take a blood sample if any abnormality was detected at the final on therapy visit or at withdrawal.
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
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 if any abnormality was detected at the final on therapy visit or at withdrawal. 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
Study medication and compliance record
Alias
- UMLS CUI-1
- C2734539
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C1321605
Beschrijving
Specify 1 - 8
Datatype
integer
Alias
- UMLS CUI [1]
- C0178602
Beschrijving
First Dose Date
Datatype
date
Alias
- UMLS CUI [1]
- C3173309
Beschrijving
Date last dose
Datatype
date
Alias
- UMLS CUI [1]
- C1762893
Beschrijving
Number of tablets dispensed
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0304229
Beschrijving
Number of tablets returned
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0304229
Beschrijving
Dose changes
Alias
- UMLS CUI-1
- C1707811
Beschrijving
Study Medication Week number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439230
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0008972
Beschrijving
Specify 1 - 8
Datatype
integer
Alias
- UMLS CUI [1]
- C0178602
Beschrijving
First Dose Date
Datatype
date
Alias
- UMLS CUI [1]
- C3173309
Beschrijving
Date last dose
Datatype
date
Alias
- UMLS CUI [1]
- C1762893
Beschrijving
Number of tablets dispensed
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0304229
Beschrijving
Number of tablets returned
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0304229
Beschrijving
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Beschrijving
If 'Yes', please record details below using standard medical terminology
Datatype
integer
Alias
- UMLS CUI [1]
- C0199171
- UMLS CUI [2]
- C0087111
- UMLS CUI [3]
- C0430022
- UMLS CUI [4]
- C0543467
Beschrijving
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Beschrijving
Procedure
Datatype
text
Alias
- UMLS CUI [1]
- C0199171
Beschrijving
All indications for procedures should be recorded in either the Adverse Experiences and/or SAE sections as appropriate.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C3146298
Beschrijving
Procedure Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0808070
Beschrijving
End Date Procedure
Datatype
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0806020
Beschrijving
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Drug name
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
eg. 500 mg
Datatype
text
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
start date of medication
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
End Date of medication
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0521116
Beschrijving
Adverse experience (non-serious)
Alias
- UMLS CUI-1
- C1518404
Beschrijving
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).
Datatype
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Adverse experience (non-serious)
Alias
- UMLS CUI-1
- C1518404
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Adverse Event Start Date Time
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826806
Beschrijving
(If ongoing please leave blank)
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826793
Beschrijving
If patient died, STOP: go to SAE section and follow instructions given there
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
adverse event course
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschrijving
only answer if previous answer was 'intermittent'
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Beschrijving
Intensity concerning the maximum
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Beschrijving
Action Taken with Respect to Investigational Drug
Datatype
integer
Alias
- UMLS CUI [1]
- C2826626
Beschrijving
Relationship to Investigational Drug
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
f ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
Was patient withdrawn due to this specific AE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
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
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 - Follow-up
- StudyEvent: ODM
C0035258 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
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])
C0566251 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])