ID
24335
Description
Part 2 of EW1/FU1 - Early Withdrawals and Follow-up 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
Keywords
Versions (1)
- 7/30/17 7/30/17 -
Copyright Holder
glaxoSmithKline
Uploaded on
July 30, 2017
DOI
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License
Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Follow up of Early Withdrawals 1
GSK study: Ropinirole in RLS patients 101468/243 - Follow-up of Early Withdrawals 1
Description
Vital signs
Alias
- UMLS CUI-1
- C0518766
Description
after 5min sitting
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Description
after 5 minutes sitting
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Description
after 5 minutes sitting
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Description
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Adverse reaction
Alias
- UMLS CUI-1
- C0559546
Description
Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
Description
Please take a blood sample if any abnormality was detected at the final on therapy visit or at withdrawal.
Data type
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Description
Laboratory label
Data type
text
Alias
- UMLS CUI [1]
- C4273937
Description
If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this module
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1704258
Description
Urine dipstick
Alias
- UMLS CUI-1
- C0430370
Description
Please perform a urine dipstick for presence of blood or protein, 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.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Description
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Description
If 'Yes', please record details below using standard medical terminology
Data type
integer
Alias
- UMLS CUI [1]
- C0199171
- UMLS CUI [2]
- C0087111
- UMLS CUI [3]
- C0430022
- UMLS CUI [4]
- C0543467
Description
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Description
Procedure
Data type
text
Alias
- UMLS CUI [1]
- C0199171
Description
All indications for procedures should be recorded in either the Adverse Experiences and/or SAE sections as appropriate.
Data type
text
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C3146298
Description
Procedure Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0808070
Description
End Date Procedure
Data type
date
Alias
- UMLS CUI [1,1]
- C0199171
- UMLS CUI [1,2]
- C0806020
Description
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Description
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Description
Drug name
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
eg. 500 mg
Data type
text
Alias
- UMLS CUI [1]
- C2348070
Description
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.
Data type
text
Alias
- UMLS CUI [1]
- C0011900
Description
start date of medication
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
End Date of medication
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
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.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0521116
Description
Adverse experience (non-serious)
Alias
- UMLS CUI-1
- C1518404
Description
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).
Data type
boolean
Alias
- UMLS CUI [1]
- C1518404
Description
Adverse experience (non-serious)
Alias
- UMLS CUI-1
- C1518404
Description
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.
Data type
text
Alias
- UMLS CUI [1]
- C1518404
Description
Adverse Event Start Date Time
Data type
datetime
Alias
- UMLS CUI [1]
- C2826806
Description
(If ongoing please leave blank)
Data type
datetime
Alias
- UMLS CUI [1]
- C2826793
Description
If patient died, STOP: go to SAE section and follow instructions given there
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
adverse event course
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
only answer if previous answer was 'intermittent'
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Description
Intensity concerning the maximum
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
Description
Action Taken with Respect to Investigational Drug
Data type
integer
Alias
- UMLS CUI [1]
- C2826626
Description
Relationship to Investigational Drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
f ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
Was patient withdrawn due to this specific AE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
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GSK study: Ropinirole in RLS patients 101468/243 - Follow-up of Early Withdrawals 1
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