ID

24329

Beschreibung

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

Stichworte

Versionen (1)
  1. 30.07.17 30.07.17 -
Rechteinhaber

glaxoSmithKline

Hochgeladen am

30. Juli 2017

DOI

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GSK study: Ropinirole in RLS patients 101468/243 - Follow up

Englisch

GSK study: Ropinirole in RLS patients 101468/243 - Follow-up

1 Formulare  
RLS Rating scale
Beschreibung

RLS Rating scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C0035258
RLS Rating scale
Beschreibung

Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book

Datentyp

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
Pulse
Beschreibung

after 5min sitting

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Sitting systolic blood pressure
Beschreibung

after 5 minutes sitting

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting diastolic blood pressure
Beschreibung

after 5 minutes sitting

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Concomitant Medication
Beschreibung

Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this module

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Adverse reaction
Beschreibung

Adverse reaction

Alias
UMLS CUI-1
C0559546
Adverse reaction
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1]
C0559546
Medical procedures
Beschreibung

Medical procedures

Alias
UMLS CUI-1
C0199171
Medical Procedures
Beschreibung

Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this module

Datentyp

text

Alias
UMLS CUI [1]
C0199171
Laboratory evaluation
Beschreibung

Laboratory evaluation

Alias
UMLS CUI-1
C0022885
Date of blood sample
Beschreibung

Please take a blood sample if any abnormality was detected at the final on therapy visit or at withdrawal.

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Please affix the Quest Diagnostics Laboratory label here.
Beschreibung

Laboratory label

Datentyp

text

Alias
UMLS CUI [1]
C4273937
Were any clinically significant abnormalities detected?
Beschreibung

If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this module

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1704258
Urine dipstick
Beschreibung

Urine dipstick

Alias
UMLS CUI-1
C0430370
What was the result of the urine dipstick performed at this visit?
Beschreibung

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.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Study medication and compliance record
Beschreibung

Study medication and compliance record

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
UMLS CUI-3
C1321605
Dose Level
Beschreibung

Specify 1 - 8

Datentyp

integer

Alias
UMLS CUI [1]
C0178602
Date of first dose
Beschreibung

First Dose Date

Datentyp

date

Alias
UMLS CUI [1]
C3173309
Date of last dose
Beschreibung

Date last dose

Datentyp

date

Alias
UMLS CUI [1]
C1762893
Number of tablets dispensed
Beschreibung

Number of tablets dispensed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0304229
Number of tablets returned
Beschreibung

Number of tablets returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0304229
Dose changes
Beschreibung

Dose changes

Alias
UMLS CUI-1
C1707811
Study Medication Week number
Beschreibung

Study Medication Week number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439230
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0008972
Dose Level
Beschreibung

Specify 1 - 8

Datentyp

integer

Alias
UMLS CUI [1]
C0178602
Date of first dose
Beschreibung

First Dose Date

Datentyp

date

Alias
UMLS CUI [1]
C3173309
Date of last dose
Beschreibung

Date last dose

Datentyp

date

Alias
UMLS CUI [1]
C1762893
Number of tablets dispensed
Beschreibung

Number of tablets dispensed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0304229
Number of tablets returned
Beschreibung

Number of tablets returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0304229
Medical procedures
Beschreibung

Medical procedures

Alias
UMLS CUI-1
C0199171
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed during the module?
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
Medical procedures
Beschreibung

Medical procedures

Alias
UMLS CUI-1
C0199171
Procedure
Beschreibung

Procedure

Datentyp

text

Alias
UMLS CUI [1]
C0199171
Indication
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
Procedure Start Date
Beschreibung

Procedure Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0808070
End Date Procedure
Beschreibung

End Date Procedure

Datentyp

date

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0806020
Concomitant medication
Beschreibung

Concomitant medication

Alias
UMLS CUI-1
C2347852
Please mark with 'yes', if there has been no new or change in concomitant medication during the module
Beschreibung

Mark box below or complete page with concomitant medication details (Please print clearly).

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant medication
Beschreibung

Concomitant medication

Alias
UMLS CUI-1
C2347852
Drug name (Trade name preferred)
Beschreibung

Drug name

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose
Beschreibung

eg. 500 mg

Datentyp

text

Alias
UMLS CUI [1]
C2348070
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
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
Start Date (be as precise as possible)
Beschreibung

start date of medication

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Beschreibung

End Date of medication

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Does the medication still continue?
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
Adverse experience (non-serious)
Beschreibung

Adverse experience (non-serious)

Alias
UMLS CUI-1
C1518404
Please mark this box if no adverse experiences occurred during the module.
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
Adverse experience (non-serious)
Beschreibung

Adverse experience (non-serious)

Alias
UMLS CUI-1
C1518404
Adverse experience
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
Onset Date and Time
Beschreibung

Adverse Event Start Date Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826806
End Date and Time
Beschreibung

(If ongoing please leave blank)

Datentyp

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Beschreibung

If patient died, STOP: go to SAE section and follow instructions given there

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Experience Course
Beschreibung

adverse event course

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Number of episodes
Beschreibung

only answer if previous answer was 'intermittent'

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Beschreibung

Intensity concerning the maximum

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Action Taken with Respect to Investigational Drug
Beschreibung

Action Taken with Respect to Investigational Drug

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
Relationship to Investigational Drug
Beschreibung

Relationship to Investigational Drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Corrective Therapy
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
Was patient withdrawn due to this specific AE?
Beschreibung

Was patient withdrawn due to this specific AE?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Pregnancy information
Beschreibung

Pregnancy information

Alias
UMLS CUI-1
C0032961
Did the patient become pregnant during the study?
Beschreibung

If ’Yes’ please record details on the Pregnancy Notification Form, if not already completed.

Datentyp

text

Alias
UMLS CUI [1]
C0032961
Study conclusion
Beschreibung

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Did the patient complete the study according to the protocol?
Beschreibung

If 'No' please mark the primary cause of withdrawal.

Datentyp

boolean

Alias
UMLS CUI [1]
C2348577
Reason for not completing the study
Beschreibung

Reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0566251
Please specify other reason for not completing the study.
Beschreibung

Only answer, if you chose 'other' reason for not completing the study.

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Investigator signature
Beschreibung

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator signature
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
Date of Investigator signature
Beschreibung

Investigator signature date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

GSK study: Ropinirole in RLS patients 101468/243 - Follow-up

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
RLS Rating scale
C0681889 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
RLS Rating scale
Item
RLS Rating scale
text
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Pulse rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Sitting systolic blood pressure
Item
Sitting systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting diastolic blood pressure
Item
Sitting diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Concomitant Medication
text
C2347852 (UMLS CUI [1])
Item Group
Adverse reaction
C0559546 (UMLS CUI-1)
Adverse reaction
Item
Adverse reaction
text
C0559546 (UMLS CUI [1])
Item Group
Medical procedures
C0199171 (UMLS CUI-1)
Medical Procedures
Item
Medical Procedures
text
C0199171 (UMLS CUI [1])
Item Group
Laboratory evaluation
C0022885 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C4273937 (UMLS CUI [1])
laboratory results abnormalities
Item
Were any clinically significant abnormalities detected?
boolean
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
Urine dipstick
C0430370 (UMLS CUI-1)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
urine dipstick result
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
negative (1)
CL Item
positive (2)
Item Group
Study medication and compliance record
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C1321605 (UMLS CUI-3)
Dose Level
Item
Dose Level
integer
C0178602 (UMLS CUI [1])
First Dose Date
Item
Date of first dose
date
C3173309 (UMLS CUI [1])
Date last dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
Number of tablets dispensed
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Dose changes
C1707811 (UMLS CUI-1)
Study Medication Week number
Item
Study Medication Week number
integer
C0439230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Dose Level
Item
Dose Level
integer
C0178602 (UMLS CUI [1])
First Dose Date
Item
Date of first dose
date
C3173309 (UMLS CUI [1])
Date last dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
Number of tablets dispensed
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Medical procedures
C0199171 (UMLS CUI-1)
Item
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed during the module?
integer
C0199171 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0430022 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
medical procedures
Code List
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed during the module?
CL Item
no (1)
CL Item
yes (2)
Item Group
Medical procedures
C0199171 (UMLS CUI-1)
Procedure
Item
Procedure
text
C0199171 (UMLS CUI [1])
Indication of medical procedure
Item
Indication
text
C0199171 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Procedure Start Date
Item
Procedure Start Date
date
C0199171 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date Procedure
Item
End Date Procedure
date
C0199171 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Concomitant medication
Item
Please mark with 'yes', if there has been no new or change in concomitant medication during the module
boolean
C2347852 (UMLS CUI [1])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Drug name
Item
Drug name (Trade name preferred)
text
C0013227 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1])
start date of medication
Item
Start Date (be as precise as possible)
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of medication
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
medication is current
Item
Does the medication still continue?
boolean
C0013227 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Item Group
Adverse experience (non-serious)
C1518404 (UMLS CUI-1)
Non-serious adverse event
Item
Please mark this box if no adverse experiences occurred during the module.
boolean
C1518404 (UMLS CUI [1])
Item Group
Adverse experience (non-serious)
C1518404 (UMLS CUI-1)
Non-serious adverse event
Item
Adverse experience
text
C1518404 (UMLS CUI [1])
Adverse Event Start Date Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
Adverse Event End Date Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Outcome
CL Item
resolved (1)
CL Item
ongoing (2)
CL Item
died (3)
Item
Experience Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
adverse event course
Code List
Experience Course
CL Item
intermittent (1)
CL Item
constant (2)
Number of episodes of adverse event
Item
Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of the adverse event
Code List
Intensity (maximum)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Action Taken with Respect to Investigational Drug
Code List
Action Taken with Respect to Investigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped (5)
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship to Investigational Drug
Code List
Relationship to Investigational Drug
CL Item
Related (5)
CL Item
Possibly related (6)
CL Item
Probably unrelated (7)
CL Item
Unrelated (1)
Item
Corrective Therapy
integer
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Corrective therapy to adverse event
Code List
Corrective Therapy
CL Item
yes (1)
CL Item
no (2)
Was patient withdrawn due to this specific AE?
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
Item
Did the patient become pregnant during the study?
text
C0032961 (UMLS CUI [1])
pregnancy
Code List
Did the patient become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
study completed
Item
Did the patient complete the study according to the protocol?
boolean
C2348577 (UMLS CUI [1])
Item
Reason for not completing the study
integer
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason
Code List
Reason for not completing the study
CL Item
Adverse experience (please complete AE page) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other-specify (7)
Specify other reason
Item
Please specify other reason for not completing the study.
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Date of Investigator signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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