ID
24329
Beskrivning
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
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 - Follow up
GSK study: Ropinirole in RLS patients 101468/243 - Follow-up
- StudyEvent: ODM
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
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Adverse reaction
Alias
- UMLS CUI-1
- C0559546
Beskrivning
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Beskrivning
Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
Beskrivning
Please take a blood sample if any abnormality was detected at the final on therapy visit or at withdrawal.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beskrivning
Laboratory label
Datatyp
text
Alias
- UMLS CUI [1]
- C4273937
Beskrivning
If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this module
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1704258
Beskrivning
Urine dipstick
Alias
- UMLS CUI-1
- C0430370
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
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
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Beskrivning
If 'No' please mark the primary cause of withdrawal.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348577
Beskrivning
Reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0566251
Beskrivning
Only answer, if you chose 'other' reason for not completing the study.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
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 - 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])