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24132

Beschreibung

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

Stichworte

Versionen (1)
  1. 25.07.17 25.07.17 -
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GlaxoSmithKline

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25. Juli 2017

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

    Englisch

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

    1 Formulare  
    Study entry
    Beschreibung

    Study entry

    Did the patient require a screening visit?
    Beschreibung

    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.

    Datentyp

    integer

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

    Vital signs

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

    Please mark whether weight is measured is kg or lbs.

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C0005910
    Pulse
    Beschreibung

    after 5 min 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 min sitting

    Datentyp

    integer

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

    Adverse experience

    Alias
    UMLS CUI-1
    C0559546
    Adverse experience
    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
    Exclusion Criterion
    Beschreibung

    Exclusion Criterion

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

    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.

    Datentyp

    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
    Beschreibung

    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?
    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

    integer

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

    Healthcare resource utilisation - visits/contacts with physician

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

    date of visit physician

    Datentyp

    date

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

    Type of physician

    Datentyp

    integer

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

    Visit location

    Datentyp

    integer

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

    integer

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

    tests or procedures during visit

    Datentyp

    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
    Beschreibung

    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)?
    Beschreibung

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

    Datentyp

    integer

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

    Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners

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

    date of visit paramedical practitioner

    Datentyp

    date

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

    Type of paramedical practitioner

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0030450
    Visit location
    Beschreibung

    Visit location

    Datentyp

    integer

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

    integer

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

    Healthcare resource utilisation - Hospitalisation

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

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

    Datentyp

    integer

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

    Healthcare resource utilisation - hospitalisation

    Alias
    UMLS CUI-1
    C0019993
    Date of admission
    Beschreibung

    date of admission

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302393
    Date of discharge
    Beschreibung

    date of discharge

    Datentyp

    date

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

    Hospitalisation cause

    Datentyp

    text

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

    integer

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

    type of ward

    Datentyp

    integer

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

    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?
    Beschreibung

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

    Datentyp

    integer

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

    Healthcare resource utilisation - accident & emergency / emergency room visits

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

    Date of visit in A&E

    Datentyp

    date

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

    integer

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

    Clinical global impression

    Alias
    UMLS CUI-1
    C3639708
    Clinical global impression
    Beschreibung

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

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3639708
    RLS Rating scale
    Beschreibung

    RLS Rating scale

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

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

    Datentyp

    text

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

    Patient rated scale

    Alias
    UMLS CUI-1
    C0681889
    UMLS CUI-2
    C1578483
    RLS Quality of Live Questionnaire
    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
    SF36 Health Status Survey
    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
    Medical Outcome Study Sleep Scale
    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
    Work Productivity and Activity Impairment Questionnaire
    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
    Pregnancy information
    Beschreibung

    Pregnancy information

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

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

    Datentyp

    text

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

    Patient continuation/ withdrawal

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

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

    Datentyp

    integer

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

    Cause of withdrawal from study

    Datentyp

    integer

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

    Other cause of withdrawal from study

    Datentyp

    text

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

    Investigator signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator Signature
    Beschreibung

    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.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Orthostatic vital signs
    Beschreibung

    Orthostatic vital signs

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

    Pre-Dose Reading 1

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

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

    Datentyp

    time

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

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Semi-supine diastolic blood pressure
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Time vitals taken
    Beschreibung

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

    Datentyp

    time

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

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Erect diastolic blood pressure
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Pre-Dose Reading 2
    Beschreibung

    Pre-Dose Reading 2

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

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

    Datentyp

    time

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

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Semi-supine diastolic blood pressure
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Time vitals taken
    Beschreibung

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

    Datentyp

    time

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

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Erect diastolic blood pressure
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Pre-Dose Reading 3
    Beschreibung

    Pre-Dose Reading 3

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

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

    Datentyp

    time

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

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Semi-supine diastolic blood pressure
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Time vitals taken
    Beschreibung

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

    Datentyp

    time

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

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Erect diastolic blood pressure
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Time of dose
    Beschreibung

    Time of dose

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

    Time of dose

    Datentyp

    time

    Maßeinheiten
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0040223
    Hr : Min
    Dose level
    Beschreibung

    Dose level

    Datentyp

    text

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

    2 hours Post-Dose Reading 1

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

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

    Datentyp

    time

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

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Semi-supine diastolic blood pressure
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Pulse
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Time vitals taken
    Beschreibung

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

    Datentyp

    time

    Erect systolic blood pressure
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Erect diastolic blood-pressure
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Beschreibung

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

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

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

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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