ID
24333
Beschreibung
ONLY TO BE COMPLETED IF THE PATIENT IS WITHDRAWN Part 1 of EW1/ FU1: Early Withdrawal and Follow-up 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension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
Stichworte
Versionen (1)
- 30.07.17 30.07.17 -
Rechteinhaber
glaxoSmithKline
Hochgeladen am
30. Juli 2017
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1
GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1
Beschreibung
RLS Rating scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C0035258
Beschreibung
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
weight in kg
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439209
Beschreibung
Weight in lbs
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439219
Beschreibung
Weight
Datentyp
float
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
after 5min sitting
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschreibung
after 5 minutes sitting
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beschreibung
after 5 minutes sitting
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beschreibung
Medical procedures
Alias
- UMLS CUI-1
- C0199171
Beschreibung
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Adverse reaction
Alias
- UMLS CUI-1
- C0559546
Beschreibung
Patient rated scale
Alias
- UMLS CUI-1
- C0681889
- UMLS CUI-2
- C1578483
Beschreibung
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034394
- UMLS CUI [1,2]
- C0034380
- UMLS CUI [1,3]
- C0035258
Beschreibung
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Datentyp
text
Alias
- UMLS CUI [1]
- C3640521
Beschreibung
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0349674
- UMLS CUI [1,2]
- C0037313
Beschreibung
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Datentyp
text
Alias
- UMLS CUI [1]
- C3639722
Beschreibung
Healthcare resource utilisation - visits/contacts with physician
Alias
- UMLS CUI-1
- C0031831
- UMLS CUI-2
- C0545082
Beschreibung
DO NOT INCLUDE ANY WHILE IN HOSPITAL. If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0031831
- UMLS CUI [1,2]
- C0545082
Beschreibung
Healthcare resource utilisation - visits/contacts with physician
Alias
- UMLS CUI-1
- C0031831
- UMLS CUI-2
- C0545082
Beschreibung
date of visit physician
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0031831
Beschreibung
Type of physician
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031831
- UMLS CUI [1,2]
- C0332307
Beschreibung
Visit location
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0450429
Beschreibung
A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beschreibung
tests or procedures during visit
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0039593
- UMLS CUI [2,1]
- C0545082
- UMLS CUI [2,2]
- C3274430
Beschreibung
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Alias
- UMLS CUI-1
- C0030450
- UMLS CUI-2
- C0545082
Beschreibung
If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0030450
- UMLS CUI [1,2]
- C0545082
Beschreibung
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Alias
- UMLS CUI-1
- C0030450
- UMLS CUI-2
- C0545082
Beschreibung
date of visit paramedical practitioner
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0030450
Beschreibung
Type of paramedical practitioner
Datentyp
integer
Alias
- UMLS CUI [1]
- C0030450
Beschreibung
Visit location
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0450429
Beschreibung
A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beschreibung
Healthcare resource utilisation - Hospitalisation
Alias
- UMLS CUI-1
- C0019993
Beschreibung
Healthcare resource utilisation - hospitalisation
Alias
- UMLS CUI-1
- C0019993
Beschreibung
date of admission
Datentyp
date
Alias
- UMLS CUI [1]
- C1302393
Beschreibung
date of discharge
Datentyp
date
Alias
- UMLS CUI [1]
- C2361123
Beschreibung
Hospitalisation cause
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C0392360
Beschreibung
A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beschreibung
type of ward
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1305702
- UMLS CUI [1,2]
- C0332307
Beschreibung
in days
Datentyp
durationDatetime
Maßeinheiten
- days
Alias
- UMLS CUI [1,1]
- C1305702
- UMLS CUI [1,2]
- C0023303
Beschreibung
Healthcare resource utilisation - accident & emergency / emergency room visits
Alias
- UMLS CUI-1
- C0562508
- UMLS CUI-2
- C0545082
Beschreibung
Healthcare resource utilisation - accident & emergency / emergency room visits
Alias
- UMLS CUI-1
- C0562508
- UMLS CUI-2
- C0545082
Beschreibung
Date of visit in A&E
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1320303
- UMLS CUI [1,2]
- C0562508
Beschreibung
A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0439849
Beschreibung
Laboratory evaluation
Alias
- UMLS CUI-1
- C0022885
Beschreibung
Please take a blood sample for routine analysis.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschreibung
Laboratory label
Datentyp
text
Alias
- UMLS CUI [1]
- C4273937
Beschreibung
If ’Yes’, 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
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1704258
Beschreibung
Urine dipstick
Alias
- UMLS CUI-1
- C0430370
Beschreibung
Please perform a urine dipstick test for presence of blood or protein. 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
Beschreibung
Pregnancy dipstick
Alias
- UMLS CUI-1
- C0430056
Beschreibung
If ’Yes’, please perform a pregnancy dipstick test and record result below.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1960468
Beschreibung
Only answer if the patient is a female of child bearing potential. If ’Positive’, please record details on the Pregnancy Notification Form
Datentyp
integer
Alias
- UMLS CUI [1]
- C0427777
Beschreibung
Clinical global impression
Alias
- UMLS CUI-1
- C3639708
Beschreibung
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
Beschreibung
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Beschreibung
If 'No' please mark the primary cause of withdrawal.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348577
Beschreibung
Reason for not completing the study
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0566251
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
Beschreibung
Investigator signature
Alias
- UMLS CUI-1
- C2346576
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
Beschreibung
Investigator signature date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1
C0008972 (UMLS CUI-2)
C0008972 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,2])
C0439209 (UMLS CUI [1,2])
C0439219 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0034380 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0037313 (UMLS CUI [1,2])
C0545082 (UMLS CUI-2)
C0545082 (UMLS CUI [1,2])
C0545082 (UMLS CUI-2)
C0031831 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,2])
C0545082 (UMLS CUI [2,1])
C3274430 (UMLS CUI [2,2])
C0545082 (UMLS CUI-2)
C0545082 (UMLS CUI [1,2])
C0545082 (UMLS CUI-2)
C0030450 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0023303 (UMLS CUI [1,2])
C0545082 (UMLS CUI-2)
C0545082 (UMLS CUI [1,2])
C0545082 (UMLS CUI-2)
C0562508 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])