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29075

Beschreibung

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

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  1. 23.02.18 23.02.18 -
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GlaxoSmithKline (GSK)

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23. Februar 2018

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    Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857

    Englisch

    Scales, baseline signs and symptoms

    1 Formulare  
    Scales RLS
    Beschreibung

    Scales RLS

    Alias
    UMLS CUI-1
    C0450973 (Assessment scales)
    SNOMED
    273249006
    UMLS CUI-2
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    Please complete the information below based on the Baseline IRLS Rating Scale. If this score is not ≥ 15, exclude the patient
    Beschreibung

    IRLS Rating Scale

    Datentyp

    integer

    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. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale • Hospital Anxiety and Depression Scale (HADS)
    Beschreibung

    If the patient is eligible to continue in the study please continue the assessments for this visit as stated below:

    Datentyp

    boolean

    Vital signs
    Beschreibung

    Vital signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Pulse (after 5 minutes sitting)
    Beschreibung

    Pulse

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    beats/min
    Sitting Blood Pressure (after 5 minutes sitting) systolic / diastolic
    Beschreibung

    Blood pressure

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    mmHg
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    Beschreibung

    Concomitant medication

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    Beschreibung

    Medical Procedures

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0199171 (Medical procedure)
    Baseline signs and symptoms
    Beschreibung

    Baseline signs and symptoms

    Alias
    UMLS CUI-1
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    If you consider this to be a serious baseline event (SBE), please do not enter on this page but enter in the Serious Adverse Experience section (SAE) (See opposite for definitions of an SBE)
    Beschreibung

    Serious baseline events

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1519255 (Serious Adverse Event)
    Please mark this box if no baseline events occurred prior to randomisation into study.
    Beschreibung

    Baseline events

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Baseline signs and symptoms
    Beschreibung

    Baseline signs and symptoms

    Alias
    UMLS CUI-1
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    Onset Date and Time
    Beschreibung

    Onset Date and Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1]
    C2826806 (Adverse Event Start Date Time)
    End Date and Time (If ongoing please leave blank)
    Beschreibung

    End Date and Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1]
    C2826793 (Adverse Event End Date Time)
    Outcome If patient died, STOP: go to SAE section and follow instructions given there
    Beschreibung

    Outcome

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1705586 (Adverse Event Outcome)
    Event Course
    Beschreibung

    Event Course

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0750729 (Course)
    SNOMED
    288524001
    Event Course, if 'intermittent' please specify No. of episodes:
    Beschreibung

    Event Course

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0750729 (Course)
    SNOMED
    288524001
    Intensity (maximum)
    Beschreibung

    INTENSITY (Maximum) MILD An event which is easily tolerated MODERATE An event which is sufficiently discomforting to interfere with daily activities SEVERE An event which prevents normal everyday activities

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1710066 (Severity of Adverse Event)
    Relationship to study procedures performed prior to randomisation
    Beschreibung

    RELATIONSHIP TO STUDY PROCEDURES RELATED There is a direct cause and effect relationship between the event and the study procedures POSSIBLY RELATED A direct cause and effect relationship between the study procedures and the event has not been demonstrated but is possible or likely PROBABLY UNRELATED Cause and effect relationship between the study procedures and the event has not been demonstrated, is improbable but not impossible UNRELATED The event is definitely not related to the study procedures

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1510821 (Adverse Event Attribution to Product or Procedure)
    Corrective Therapy
    Beschreibung

    If ‘Yes’, record details in Prior and Concomitant Medication section and/or Health Care Resource Utilisation section if appropriate.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    Was patient withdrawn due to this specific event?
    Beschreibung

    Withdrawal related to adverse event

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Ramos Randomisation and Dispensing
    Beschreibung

    Ramos Randomisation and Dispensing

    Alias
    UMLS CUI-1
    C0034656 (Randomization)
    UMLS CUI-2
    C0947323 (Dispensing medication)
    SNOMED
    373784005
    Randomisation number:
    Beschreibung

    Randomisation number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0034656 (Randomization)
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Container numbers:
    Beschreibung

    Container numbers

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0180098 (Containers)
    SNOMED
    706437002
    Orthostatic vital signs
    Beschreibung

    Orthostatic vital signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Orthostatic vital signs
    Beschreibung

    Orthostatic vital signs

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Reading
    Beschreibung

    Reading

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0456984 (Test Result)
    SNOMED
    277775005
    UMLS CUI [1,2]
    C0034754 (Reading (activity))
    SNOMED
    50360004
    LOINC
    LA17911-1
    Time of dose
    Beschreibung

    Time of dose

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Time Vitals Taken
    Beschreibung

    Time Vitals Taken

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Blood pressure systolic/diastolic
    Beschreibung

    Blood pressure

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    mmHg
    Pulse
    Beschreibung

    Pulse

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    beats/min
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Scales, baseline signs and symptoms

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Scales RLS
    C0450973 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    IRLS Rating Scale
    Item
    Please complete the information below based on the Baseline IRLS Rating Scale. If this score is not ≥ 15, exclude the patient
    integer
    Patient rated scales
    Item
    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. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale • Hospital Anxiety and Depression Scale (HADS)
    boolean
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Pulse
    Item
    Pulse (after 5 minutes sitting)
    integer
    C0232117 (UMLS CUI [1])
    Blood pressure
    Item
    Sitting Blood Pressure (after 5 minutes sitting) systolic / diastolic
    integer
    C0005823 (UMLS CUI [1])
    Concomitant medication
    Item
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    boolean
    C2347852 (UMLS CUI [1])
    Medical Procedures
    Item
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    boolean
    C0199171 (UMLS CUI [1])
    Item Group
    Baseline signs and symptoms
    C0037088 (UMLS CUI-1)
    Serious baseline events
    Item
    If you consider this to be a serious baseline event (SBE), please do not enter on this page but enter in the Serious Adverse Experience section (SAE) (See opposite for definitions of an SBE)
    boolean
    C1519255 (UMLS CUI [1])
    Baseline events
    Item
    Please mark this box if no baseline events occurred prior to randomisation into study.
    boolean
    C0877248 (UMLS CUI [1])
    Item Group
    Baseline signs and symptoms
    C0037088 (UMLS CUI-1)
    Onset Date and Time
    Item
    Onset Date and Time
    datetime
    C2826806 (UMLS CUI [1])
    End Date and Time
    Item
    End Date and Time (If ongoing please leave blank)
    datetime
    C2826793 (UMLS CUI [1])
    Item
    Outcome If patient died, STOP: go to SAE section and follow instructions given there
    integer
    C1705586 (UMLS CUI [1])
    Outcome
    Code List
    Outcome If patient died, STOP: go to SAE section and follow instructions given there
    CL Item
    [1] Resolved (1)
    CL Item
    [2] Ongoing (2)
    CL Item
    [3] Died (3)
    Item
    Event Course
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Event Course
    Code List
    Event Course
    CL Item
    [1] Intermittent (1)
    CL Item
    [2] Constant (2)
    Event Course
    Item
    Event Course, if 'intermittent' please specify No. of episodes:
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Item
    Intensity (maximum)
    integer
    C1710066 (UMLS CUI [1])
    Intensity
    Code List
    Intensity (maximum)
    CL Item
    [1] Mild (1)
    CL Item
    [2] Moderate (2)
    CL Item
    [3] Severe (3)
    Item
    Relationship to study procedures performed prior to randomisation
    integer
    C1510821 (UMLS CUI [1])
    Relationship to study procedures
    Code List
    Relationship to study procedures performed prior to randomisation
    CL Item
    [5] Related (1)
    CL Item
    [6] Possibly related (2)
    CL Item
    [7] Probably unrelated (3)
    CL Item
    [1] Unrelated (4)
    Corrective Therapy
    Item
    Corrective Therapy
    boolean
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Withdrawal related to adverse event
    Item
    Was patient withdrawn due to this specific event?
    boolean
    C2349954 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item Group
    Ramos Randomisation and Dispensing
    C0034656 (UMLS CUI-1)
    C0947323 (UMLS CUI-2)
    Randomisation number
    Item
    Randomisation number:
    integer
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Container numbers
    Item
    Container numbers:
    integer
    C0180098 (UMLS CUI [1])
    Item Group
    Orthostatic vital signs
    C0518766 (UMLS CUI-1)
    Item
    Orthostatic vital signs
    integer
    C0518766 (UMLS CUI [1])
    Orthostatic vital signs
    Code List
    Orthostatic vital signs
    CL Item
    After 10 minutes semi-supine (1)
    CL Item
    After erect for 1 minute (2)
    Item
    Reading
    integer
    C0456984 (UMLS CUI [1,1])
    C0034754 (UMLS CUI [1,2])
    Reading
    Code List
    Reading
    CL Item
    Pre-Dose Reading (1)
    CL Item
    2 hours Post-Dose Reading (2)
    Time of dose
    Item
    Time of dose
    time
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Time Vitals Taken
    Item
    Time Vitals Taken
    date
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Blood pressure
    Item
    Blood pressure systolic/diastolic
    integer
    C0005823 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Zum Seitenanfang zurückkehren 

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