ID

24132

Descrizione

Part 1 of Module 3 - Baseline, Day 2, Wk 1-8-Cont/Wthd 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

versioni (1)
  1. 25/07/17 25/07/17 -
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GlaxoSmithKline

Caricato su

25 luglio 2017

DOI

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Licenza

Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Baseline

Inglese

GSK study: Ropinirole in RLS patients 101468/243 - Baseline

1 moduli  
Study entry
Descrizione

Study entry

Did the patient require a screening visit?
Descrizione

If ’No’, please continue with this visit ensuring Module 1 has been completed on separate pad and placed in the CRF. If ’Yes’, please ensure that Modules 1 and 2, on separate pads have been completed and placed in the CRF then continue with this visit, completing only those sections which are appropriate.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2097637
UMLS CUI [1,2]
C1514873
Vital signs
Descrizione

Vital signs

Alias
UMLS CUI-1
C0518766
Weight (without shoes)
Descrizione

Please mark whether weight is measured is kg or lbs.

Tipo di dati

float

Alias
UMLS CUI [1]
C0005910
Pulse
Descrizione

after 5 min sitting

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Sitting systolic blood pressure
Descrizione

after 5 minutes sitting

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting diastolic blood pressure
Descrizione

after 5 min sitting

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Medical procedures
Descrizione

Medical procedures

Alias
UMLS CUI-1
C0199171
Medical Procedures
Descrizione

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

Tipo di dati

text

Alias
UMLS CUI [1]
C0199171
Concomitant Medication
Descrizione

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Concomitant medication
Descrizione

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

Tipo di dati

text

Alias
UMLS CUI [1]
C2347852
Adverse experience
Descrizione

Adverse experience

Alias
UMLS CUI-1
C0559546
Adverse experience
Descrizione

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 di dati

text

Alias
UMLS CUI [1]
C0559546
Exclusion Criterion
Descrizione

Exclusion Criterion

Alias
UMLS CUI-1
C0680251
Patient has clinically significant abnormal laboratory or ECG (where performed) findings not resolved prior to baseline examinations.
Descrizione

Please complete the following exclusion criterion. If the above question has been answered ’Yes’ exclude the patient from the study and complete the Patient Continuation/Withdrawal page, on page 19.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0022877
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C1623258
Healthcare resource utilisation - visits/contacts with physician
Descrizione

Healthcare resource utilisation - visits/contacts with physician

Alias
UMLS CUI-1
C0031831
UMLS CUI-2
C0545082
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
Descrizione

DO NOT INCLUDE ANY WHILE IN HOSPITAL. If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0545082
Healthcare resource utilisation - visits/contacts with physician
Descrizione

Healthcare resource utilisation - visits/contacts with physician

Alias
UMLS CUI-1
C0031831
UMLS CUI-2
C0545082
Date of Visit
Descrizione

date of visit physician

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0031831
Type of physician
Descrizione

Type of physician

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0332307
Visit Location
Descrizione

Visit location

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0450429
Was the Visit RLS Related
Descrizione

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.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Were any tests or procedures prescribed or conducted at this visit?
Descrizione

tests or procedures during visit

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0039593
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C3274430
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Descrizione

Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners

Alias
UMLS CUI-1
C0030450
UMLS CUI-2
C0545082
In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
Descrizione

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0030450
UMLS CUI [1,2]
C0545082
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Descrizione

Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners

Alias
UMLS CUI-1
C0030450
UMLS CUI-2
C0545082
Date of visit
Descrizione

date of visit paramedical practitioner

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0030450
Type of paramedical practitioner
Descrizione

Type of paramedical practitioner

Tipo di dati

integer

Alias
UMLS CUI [1]
C0030450
Visit location
Descrizione

Visit location

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0450429
Was the Visit RLS Related
Descrizione

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.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Healthcare resource utilisation - Hospitalisation
Descrizione

Healthcare resource utilisation - Hospitalisation

Alias
UMLS CUI-1
C0019993
In the past 4 weeks...was the patient hospitalised?
Descrizione

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each hospitalisation:

Tipo di dati

integer

Alias
UMLS CUI [1]
C0019993
Healthcare resource utilisation - hospitalisation
Descrizione

Healthcare resource utilisation - hospitalisation

Alias
UMLS CUI-1
C0019993
Date of admission
Descrizione

date of admission

Tipo di dati

date

Alias
UMLS CUI [1]
C1302393
Date of discharge
Descrizione

date of discharge

Tipo di dati

date

Alias
UMLS CUI [1]
C2361123
Main reason for stay
Descrizione

Hospitalisation cause

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0392360
Was the Visit RLS Related
Descrizione

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.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Type of ward
Descrizione

type of ward

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1305702
UMLS CUI [1,2]
C0332307
Healthcare resource utilisation - accident & emergency / emergency room visits
Descrizione

Healthcare resource utilisation - accident & emergency / emergency room visits

Alias
UMLS CUI-1
C0562508
UMLS CUI-2
C0545082
In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
Descrizione

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0562508
UMLS CUI [1,2]
C0545082
Healthcare resource utilisation - accident & emergency / emergency room visits
Descrizione

Healthcare resource utilisation - accident & emergency / emergency room visits

Alias
UMLS CUI-1
C0562508
UMLS CUI-2
C0545082
Date of visit
Descrizione

Date of visit in A&E

Tipo di dati

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0562508
Was the Visit RLS Related
Descrizione

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.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Clinical global impression
Descrizione

Clinical global impression

Alias
UMLS CUI-1
C3639708
Clinical global impression
Descrizione

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Tipo di dati

text

Alias
UMLS CUI [1]
C3639708
RLS Rating scale
Descrizione

RLS Rating scale

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

Please complete the Baseline RLS Rating Scale from the RLS Rating Scale Book.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Patient rated scale
Descrizione

Patient rated scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C1578483
RLS Quality of Live Questionnaire
Descrizione

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

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0034380
UMLS CUI [1,3]
C0035258
SF36 Health Status Survey
Descrizione

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

Tipo di dati

text

Alias
UMLS CUI [1]
C3640521
Medical Outcome Study Sleep Scale
Descrizione

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

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0349674
UMLS CUI [1,2]
C0037313
Work Productivity and Activity Impairment Questionnaire
Descrizione

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

Tipo di dati

text

Alias
UMLS CUI [1]
C3639722
Pregnancy information
Descrizione

Pregnancy information

Alias
UMLS CUI-1
C0032961
Has the patient become pregnant to date?
Descrizione

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

Tipo di dati

text

Alias
UMLS CUI [1]
C0032961
Patient continuation/ withdrawal
Descrizione

Patient continuation/ withdrawal

Alias
UMLS CUI-1
C2348568
Is the patient continuing in the study?
Descrizione

If ’No’, please mark the primary cause of withdrawal.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0549178
Cause of withdrawal from study
Descrizione

Cause of withdrawal from study

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0085978
Please specify 'other' cause of withdrawal from study.
Descrizione

Other cause of withdrawal from study

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0205394
Investigator signature
Descrizione

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator Signature
Descrizione

Investigator Signature: 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 di dati

text

Alias
UMLS CUI [1]
C2346576
Orthostatic vital signs
Descrizione

Orthostatic vital signs

Alias
UMLS CUI-1
C0518766
Pre-Dose Reading 1
Descrizione

Pre-Dose Reading 1

Alias
UMLS CUI-1
C1522609
UMLS CUI-2
C0439565
Time vitals taken
Descrizione

Pre-Dose Reading 1: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Semi-supine systolic blood pressure
Descrizione

Pre-Dose Reading 1: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-supine diastolic blood pressure
Descrizione

Pre-Dose Reading 1: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Descrizione

Pre-Dose Reading 1: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Time vitals taken
Descrizione

Pre-Dose Reading 1: after erect for 1 min. 40 min prior to dosing.

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Erect systolic blood pressure
Descrizione

Pre-Dose Reading 1: after erect for 1 min. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Erect diastolic blood pressure
Descrizione

Pre-Dose Reading 1: after erect for 1 min. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Descrizione

Pre-Dose Reading 1: after erect for 1 min. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Pre-Dose Reading 2
Descrizione

Pre-Dose Reading 2

Alias
UMLS CUI-1
C1522609
UMLS CUI-2
C0439565
Time vitals taken
Descrizione

Pre-Dose Reading 2: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Semi-supine systolic blood pressure
Descrizione

Pre-Dose Reading 2: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-supine diastolic blood pressure
Descrizione

Pre-Dose Reading 2: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Descrizione

Pre-Dose Reading 2: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Time vitals taken
Descrizione

Pre-Dose Reading 2: after erect for 1 min. 40 min prior to dosing.

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Erect systolic blood pressure
Descrizione

Pre-Dose Reading 2: after erect for 1 min. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Erect diastolic blood pressure
Descrizione

Pre-Dose Reading 2: after erect for 1 min. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Descrizione

Pre-Dose Reading 2: after erect for 1 min. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Pre-Dose Reading 3
Descrizione

Pre-Dose Reading 3

Alias
UMLS CUI-1
C1522609
UMLS CUI-2
C0439565
Time vitals taken
Descrizione

Pre-Dose Reading 3: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Semi-supine systolic blood pressure
Descrizione

Pre-Dose Reading 3: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-supine diastolic blood pressure
Descrizione

Pre-Dose Reading 3: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Descrizione

Pre-Dose Reading 3: after 10 min in semi-supine position. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Time vitals taken
Descrizione

Pre-Dose Reading 3: after erect for 1 min. 40 min prior to dosing.

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Erect systolic blood pressure
Descrizione

Pre-Dose Reading 3: after erect for 1 min. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Erect diastolic blood pressure
Descrizione

Pre-Dose Reading 3: after erect for 1 min. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Descrizione

Pre-Dose Reading 3: after erect for 1 min. 40 min prior to dosing.

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Time of dose
Descrizione

Time of dose

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0040223
Time of dose
Descrizione

Time of dose

Tipo di dati

time

Unità di misura
  • Hr : Min
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Hr : Min
Dose level
Descrizione

Dose level

Tipo di dati

text

Alias
UMLS CUI [1]
C0178602
2 hours Post-Dose Reading 1
Descrizione

2 hours Post-Dose Reading 1

Alias
UMLS CUI-1
C1522609
UMLS CUI-2
C0439572
Time vitals taken
Descrizione

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Tipo di dati

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Semi-supine systolic blood pressure
Descrizione

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-supine diastolic blood pressure
Descrizione

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Pulse
Descrizione

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Time vitals taken
Descrizione

Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

Tipo di dati

time

Erect systolic blood pressure
Descrizione

Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose. in mmHg; systolic/diastolic

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Erect diastolic blood-pressure
Descrizione

Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Descrizione

Pre-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
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Similar models

GSK study: Ropinirole in RLS patients 101468/243 - Baseline

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Study entry
Item
Did the patient require a screening visit?
integer
C2097637 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Screening visit required
Code List
Did the patient require a screening visit?
CL Item
no (1)
CL Item
yes (2)
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight (without shoes)
float
C0005910 (UMLS CUI [1])
Pulse
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
Medical procedures
C0199171 (UMLS CUI-1)
Medical Procedures
Item
Medical Procedures
text
C0199171 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant medication
Item
Concomitant medication
text
C2347852 (UMLS CUI [1])
Item Group
Adverse experience
C0559546 (UMLS CUI-1)
Adverse reaction
Item
Adverse experience
text
C0559546 (UMLS CUI [1])
Item Group
Exclusion Criterion
C0680251 (UMLS CUI-1)
Item
Patient has clinically significant abnormal laboratory or ECG (where performed) findings not resolved prior to baseline examinations.
integer
C0680251 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
Exclusion because of abnormal laboratory or ECG
Code List
Patient has clinically significant abnormal laboratory or ECG (where performed) findings not resolved prior to baseline examinations.
CL Item
yes (1)
CL Item
no (2)
Item Group
Healthcare resource utilisation - visits/contacts with physician
C0031831 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Item
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
integer
C0031831 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
visit physician in the last 4 weeks
Code List
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
CL Item
no (1)
CL Item
yes (2)
Item Group
Healthcare resource utilisation - visits/contacts with physician
C0031831 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
date of visit physician
Item
Date of Visit
date
C1320303 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Item
Type of physician
integer
C0031831 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Physician
Code List
Type of physician
CL Item
Cardiologist (1)
CL Item
Diabetologist (2)
CL Item
Dermatologist (3)
CL Item
Endocrinologist (4)
CL Item
ENT (Ear Nose & Throat) (5)
CL Item
Gastroenterologist (6)
CL Item
General/Internal Medical (7)
CL Item
General Practitioner/Family Practitioner  (8)
CL Item
Geriatrician (9)
CL Item
Other (99)
CL Item
Gynaecologist (10)
CL Item
Infectious Disease (11)
CL Item
Nephrologist (12)
CL Item
Neurologist (13)
CL Item
Psychiatrist (14)
CL Item
Orthopaedic (15)
CL Item
Oncologist (16)
CL Item
Ophthalmologist (17)
CL Item
Respiratory/Chest Physician  (18)
CL Item
Rheumatologist (19)
CL Item
Urologist (20)
CL Item
Sleep Disorder Specialist  (21)
Item
Visit Location
integer
C0545082 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Visit location
Code List
Visit Location
CL Item
Non hospital Office visit (eg GP surgery, Specialist's office etc) (1)
CL Item
Hospital Out Patient visit (2)
CL Item
At the Patient's home / domiciliary visit (3)
Item
Was the Visit RLS Related
integer
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the Visit RLS Related
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item
Were any tests or procedures prescribed or conducted at this visit?
integer
C0545082 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0545082 (UMLS CUI [2,1])
C3274430 (UMLS CUI [2,2])
tests or procedures during visit
Code List
Were any tests or procedures prescribed or conducted at this visit?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item Group
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
C0030450 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Item
In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
integer
C0030450 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Paramedical Practitioner
Code List
In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
CL Item
no (1)
CL Item
yes (2)
Item Group
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
C0030450 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
date of visit paramedical practitioner
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C0030450 (UMLS CUI [1,2])
Item
Type of paramedical practitioner
integer
C0030450 (UMLS CUI [1])
Type of paramedical practitioner
Code List
Type of paramedical practitioner
CL Item
Acupuncturist (1)
CL Item
Chiropodist/ Footcare Practitioner (2)
CL Item
Chiropractor (3)
CL Item
Dentist (4)
CL Item
Dietician (5)
CL Item
Homeopath/Herbalist (6)
CL Item
Nurse (7)
CL Item
Osteopath (8)
CL Item
9 - Physiotherapist (9)
CL Item
99 - Other (10)
Item
Visit location
integer
C0545082 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Visit location
Code List
Visit location
CL Item
Non hospital Office visit (1)
CL Item
Hospital Out Patient visit (2)
CL Item
At the Patient's home / domiciliary visit (3)
Item
Was the Visit RLS Related
integer
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the Visit RLS Related
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item Group
Healthcare resource utilisation - Hospitalisation
C0019993 (UMLS CUI-1)
Item
In the past 4 weeks...was the patient hospitalised?
integer
C0019993 (UMLS CUI [1])
Hospitalisation
Code List
In the past 4 weeks...was the patient hospitalised?
CL Item
no (1)
CL Item
yes (2)
Item Group
Healthcare resource utilisation - hospitalisation
C0019993 (UMLS CUI-1)
date of admission
Item
Date of admission
date
C1302393 (UMLS CUI [1])
date of discharge
Item
Date of discharge
date
C2361123 (UMLS CUI [1])
Hospitalisation cause
Item
Main reason for stay
text
C0019993 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item
Was the Visit RLS Related
integer
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the Visit RLS Related
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item
Type of ward
integer
C1305702 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
type of ward
Code List
Type of ward
CL Item
Cardiovascular (1)
CL Item
Dermatological (2)
CL Item
Endocrinological (3)
CL Item
ENT (Ear, Nose & Throat)  (4)
CL Item
Gastroenterological (5)
CL Item
General Medical (6)
CL Item
Geriatric (7)
CL Item
Gynaecological (8)
CL Item
Infectious Disease  (9)
CL Item
Nephrological (10)
CL Item
Intensive Care  (11)
CL Item
Neurological  (12)
CL Item
Psychiatric (13)
CL Item
Orthopaedic  (14)
CL Item
Oncology (15)
CL Item
Ophthalmological  (16)
CL Item
Respiratory/Chest  (17)
CL Item
Rheumatological  (18)
CL Item
Urological (19)
CL Item
Other (99)
Item Group
Healthcare resource utilisation - accident & emergency / emergency room visits
C0562508 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Item
In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
integer
C0562508 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
emergency room visits
Code List
In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
CL Item
no (1)
CL Item
yes (2)
Item Group
Healthcare resource utilisation - accident & emergency / emergency room visits
C0562508 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Date of visit in A&E
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C0562508 (UMLS CUI [1,2])
Item
Was the Visit RLS Related
integer
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the Visit RLS Related
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item Group
Clinical global impression
C3639708 (UMLS CUI-1)
Clinical global impression
Item
Clinical global impression
text
C3639708 (UMLS CUI [1])
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
Patient rated scale
C0681889 (UMLS CUI-1)
C1578483 (UMLS CUI-2)
RLS Quality of Live Questionnaire
Item
RLS Quality of Live Questionnaire
text
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
SF36 Health Status Survey
Item
SF36 Health Status Survey
text
C3640521 (UMLS CUI [1])
Medical Outcome Study Sleep Scale
Item
Medical Outcome Study Sleep Scale
text
C0349674 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
Work Productivity and Activity Impairment Questionnaire
Item
Work Productivity and Activity Impairment Questionnaire
text
C3639722 (UMLS CUI [1])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
Item
Has the patient become pregnant to date?
text
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Has the patient become pregnant to date?
CL Item
Not applicable (not of childbearing potential or male) (x)
CL Item
no (n)
CL Item
yes (y)
Item Group
Patient continuation/ withdrawal
C2348568 (UMLS CUI-1)
Item
Is the patient continuing in the study?
integer
C2348568 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Continuing study
Code List
Is the patient continuing in the study?
CL Item
yes (1)
CL Item
no (2)
Item
Cause of withdrawal from study
integer
C0422727 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Cause of withdrawal from study
Code List
Cause of withdrawal from study
CL Item
Adverse experience (please complete AE page) (1)
CL Item
Does not meet inclusion/exclusion criteria (10)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other-specify: (7)
Other cause of withdrawal from study
Item
Please specify 'other' cause of withdrawal from study.
text
C0422727 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Item Group
Orthostatic vital signs
C0518766 (UMLS CUI-1)
Item Group
Pre-Dose Reading 1
C1522609 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Semi-supine Systolic blood pressure
Item
Semi-supine systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Semi-supine diastolic blood pressure
Item
Semi-supine diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Erect systolic blood pressure
Item
Erect systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Erect diastolic blood pressure
Item
Erect diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item Group
Pre-Dose Reading 2
C1522609 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Semi-supine systolic blood pressure
Item
Semi-supine systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Semi-supine diastolic blood pressure
Item
Semi-supine diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Erect systolic blood pressure
Item
Erect systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Erect diastolic blood pressure
Item
Erect diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item Group
Pre-Dose Reading 3
C1522609 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Semi-supine systolic blood pressure
Item
Semi-supine systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Semi-supine diastolic blood pressure
Item
Semi-supine diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Erect systolic blood pressure
Item
Erect systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Erect diastolic blood pressure
Item
Erect diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item Group
Time of dose
C0013227 (UMLS CUI-1)
C0040223 (UMLS CUI-2)
Time of dose
Item
Time of dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dose level
Item
Dose level
text
C0178602 (UMLS CUI [1])
Item Group
2 hours Post-Dose Reading 1
C1522609 (UMLS CUI-1)
C0439572 (UMLS CUI-2)
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Semi-supine systolic blood pressure
Item
Semi-supine systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Semi-supine diastolic blood pressure
Item
Semi-supine diastolic blood pressure
integer
C0871470 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Time vitals taken
Item
Time vitals taken
time
Erect systolic blood pressure
Item
Erect systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Erect diastolic blood-pressure
Item
Erect diastolic blood-pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
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