ID
24329
Descripción
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
Palabras clave
Versiones (1)
- 30/7/17 30/7/17 -
Titular de derechos de autor
glaxoSmithKline
Subido en
30 de julio de 2017
DOI
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Licencia
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
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
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
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Descripción
Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
Descripción
Please take a blood sample if any abnormality was detected at the final on therapy visit or at withdrawal.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Descripción
Laboratory label
Tipo de datos
text
Alias
- UMLS CUI [1]
- C4273937
Descripción
If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this module
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1704258
Descripción
Urine dipstick
Alias
- UMLS CUI-1
- C0430370
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
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
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Descripción
If 'No' please mark the primary cause of withdrawal.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2348577
Descripción
Reason
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0566251
Descripción
Only answer, if you chose 'other' reason for not completing the study.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
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 - 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])