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25113

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Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

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Versioner (2)
  1. 2017-08-26 2017-08-26 -
  2. 2021-09-17 2021-09-17 -
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26 augusti 2017

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    TIME AND EVENTS TABLE Ropinirole Case Report Form GSK RRL100013

    Tysk Engelsk

    TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

    1 Formulär  
    Zeitplan
    Beskrivning

    Zeitplan

    Bewertung
    Beskrivning

    Assessments

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    IRLSSG diagnostische Kriterien
    Beskrivning

    IRLSSG diagnostic criteria

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    UMLS CUI [1,2]
    C2348561 (Study Population (group))
    Einschlusskriterien & Ausschlusskriterien
    Beskrivning

    Inclusion/exclusion criteria

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1512693 (Inclusion)
    UMLS CUI [1,2]
    C0680251 (Exclusion Criteria)
    Patientendaten
    Beskrivning

    Subject demography

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0011298 (Demography)
    LOINC
    LP204151-7
    RSL Anamnese
    Beskrivning

    RLS history

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0035258 (Restless Legs Syndrome)
    SNOMED
    32914008
    RR
    Beskrivning

    Orthostatic blood pressure and heart rate

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1095971 (Orthostatic blood pressure)
    LOINC
    LP31920-9
    Gewicht
    Beskrivning

    Weight

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    Größe
    Beskrivning

    Height

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    EKG
    Beskrivning

    ECG

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    Anamnese
    Beskrivning

    Medical/surgical history

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [1,2]
    C0455610 (H/O: surgery)
    SNOMED
    161615003
    Körperliche Untersuchung
    Beskrivning

    Physical examination

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Labor
    Beskrivning

    Laboratory evaluation

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    Medikamente
    Beskrivning

    Prior/concomitant medication

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Schwangerschaftstest
    Beskrivning

    Pregnancy test

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    Symptom Tagebuch
    Beskrivning

    Dispense Subject Symptom Diary

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2216446 (maintain symptom diary)
    Aktigraphie
    Beskrivning

    Dispense Actigraphy device

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1171301 (Actigraphy)
    IRLS Beurteilungsskala
    Beskrivning

    IRLS Rating Scale

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0681889 (rating scale)
    CGI Beurteilung
    Beskrivning

    CGI Scales (Improvement & Severity)

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3639708 (Clinical global impression scale)
    Insomnie Schweregradindex
    Beskrivning

    Insomnia Severity Index

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0917801 (Sleeplessness)
    schriftliche Einwilligungserklärung
    Beskrivning

    Written informed consent

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Verbesserung
    Beskrivning

    Dispense Patient Global Improvement Scale (PGI) Forms

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C2986411 (Improvement)
    UMLS CUI [1,2]
    C0349674 (Intellectual scale)
    SNOMED
    278111002
    Zufriedenheitsfragebogen
    Beskrivning

    Patient satisfaction question

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3476649 (Treatment satisfaction)
    LOINC
    LP146884-4
    Lebensqualität Fragebogen
    Beskrivning

    Quality of Life Questionnaire

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0451149 (EORTC - Quality of life questionnaire)
    SNOMED
    273446001
    Pittsburgh Schlafskala
    Beskrivning

    MOS Sleep Scale

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3697468 (Pittsburgh sleep quality index)
    SNOMED
    699200007
    Gemütszustand
    Beskrivning

    Profile of Mood States (POMS)

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0451394 (Profile of mood states)
    SNOMED
    273717007
    Krankenhaus Angstskala
    Beskrivning

    Hospital Anxiety and Depression Scale (HADS)

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0451221 (undefined)
    unerwünschtem Ereignis
    Beskrivning

    Adverse events

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Randomisierung
    Beskrivning

    Subject randomization

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0034656 (Randomization)
    Pharmacogenomics
    Beskrivning

    Pharmacogenomics sample

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1138555 (Pharmacogenomics)
    SNOMED
    720505003
    LOINC
    LP203674-9
    Schlussfolgerung
    Beskrivning

    Study conclusion form

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1707478 (Conclusion)
    Tillbaka till toppen

    Similar models

    TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Zeitplan
    Item
    Bewertung
    integer
    C0220825 (UMLS CUI [1])
    Assessments
    Code List
    Bewertung
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    IRLSSG diagnostische Kriterien
    integer
    C0035258 (UMLS CUI [1,1])
    C2348561 (UMLS CUI [1,2])
    Assessments
    Code List
    IRLSSG diagnostische Kriterien
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Einschlusskriterien & Ausschlusskriterien
    integer
    C1512693 (UMLS CUI [1,1])
    C0680251 (UMLS CUI [1,2])
    Assessments
    Code List
    Einschlusskriterien & Ausschlusskriterien
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Patientendaten
    integer
    C0011298 (UMLS CUI [1])
    Assessments
    Code List
    Patientendaten
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    RSL Anamnese
    integer
    C0035258 (UMLS CUI [1])
    Assessments
    Code List
    RSL Anamnese
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    RR
    integer
    C1095971 (UMLS CUI [1])
    Assessments
    Code List
    RR
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Gewicht
    integer
    C0220825 (UMLS CUI [1])
    Assessments
    Code List
    Gewicht
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Größe
    integer
    C0005890 (UMLS CUI [1])
    Assessments
    Code List
    Größe
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    EKG
    integer
    C0220825 (UMLS CUI [1])
    Assessments
    Code List
    EKG
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Anamnese
    integer
    C0262926 (UMLS CUI [1,1])
    C0455610 (UMLS CUI [1,2])
    Assessments
    Code List
    Anamnese
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Körperliche Untersuchung
    integer
    C0031809 (UMLS CUI [1])
    Assessments
    Code List
    Körperliche Untersuchung
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Labor
    integer
    C0022885 (UMLS CUI [1])
    Assessments
    Code List
    Labor
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Medikamente
    integer
    C2347852 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Assessments
    Code List
    Medikamente
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Schwangerschaftstest
    integer
    C0032976 (UMLS CUI [1])
    Assessments
    Code List
    Schwangerschaftstest
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Symptom Tagebuch
    integer
    C2216446 (UMLS CUI [1])
    Assessments
    Code List
    Symptom Tagebuch
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Aktigraphie
    integer
    C1171301 (UMLS CUI [1])
    Assessments
    Code List
    Aktigraphie
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    IRLS Beurteilungsskala
    integer
    C0681889 (UMLS CUI [1])
    Assessments
    Code List
    IRLS Beurteilungsskala
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    CGI Beurteilung
    integer
    C3639708 (UMLS CUI [1])
    Assessments
    Code List
    CGI Beurteilung
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Insomnie Schweregradindex
    integer
    C0917801 (UMLS CUI [1])
    Assessments
    Code List
    Insomnie Schweregradindex
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    schriftliche Einwilligungserklärung
    integer
    C0021430 (UMLS CUI [1])
    Assessments
    Code List
    schriftliche Einwilligungserklärung
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Verbesserung
    integer
    C2986411 (UMLS CUI [1,1])
    C0349674 (UMLS CUI [1,2])
    Assessments
    Code List
    Verbesserung
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Zufriedenheitsfragebogen
    integer
    C3476649 (UMLS CUI [1])
    Assessments
    Code List
    Zufriedenheitsfragebogen
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Lebensqualität Fragebogen
    integer
    C0451149 (UMLS CUI [1])
    Assessments
    Code List
    Lebensqualität Fragebogen
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Pittsburgh Schlafskala
    integer
    C3697468 (UMLS CUI [1])
    Assessments
    Code List
    Pittsburgh Schlafskala
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Gemütszustand
    integer
    C0451394 (UMLS CUI [1])
    Assessments
    Code List
    Gemütszustand
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Krankenhaus Angstskala
    integer
    C0451221 (UMLS CUI [1])
    Assessments
    Code List
    Krankenhaus Angstskala
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    unerwünschtem Ereignis
    integer
    C0877248 (UMLS CUI [1])
    Assessments
    Code List
    unerwünschtem Ereignis
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Randomisierung
    integer
    C0034656 (UMLS CUI [1])
    Assessments
    Code List
    Randomisierung
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Pharmacogenomics
    integer
    C1138555 (UMLS CUI [1])
    Assessments
    Code List
    Pharmacogenomics
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
    Item
    Schlussfolgerung
    integer
    C1707478 (UMLS CUI [1])
    Assessments
    Code List
    Schlussfolgerung
    CL Item
    Screening (1)
    C1409616 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Baseline (2)
    C1442488 (UMLS CUI-1)
    (Comment:en)
    CL Item
    12 Week Double-Blind Treatment Phase (3)
    C0013072 (UMLS CUI-1)
    C0814495 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Early withdrawal (4)
    C2349954 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Follow Up (5)
    C1522577 (UMLS CUI-1)
    (Comment:en)
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