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ID

42909

Beschrijving

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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Versies (2)
  1. 26-08-17 26-08-17 -
  2. 17-09-21 17-09-21 -
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17 september 2021

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    TIME AND EVENTS TABLE Ropinirole Case Report Form GSK RRL100013

    Duits Engels

    TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

    1 Formulieren  
    Zeitplan
    Beschrijving

    Zeitplan

    Bewertung
    Beschrijving

    Assessments

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0220825
    IRLSSG diagnostische Kriterien
    Beschrijving

    IRLSSG diagnostic criteria

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C2348561
    Einschlusskriterien & Ausschlusskriterien
    Beschrijving

    Inclusion/exclusion criteria

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0680251
    Patientendaten
    Beschrijving

    Subject demography

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0011298
    RSL Anamnese
    Beschrijving

    RLS history

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0035258
    RR
    Beschrijving

    Orthostatic blood pressure and heart rate

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1095971
    Gewicht
    Beschrijving

    Weight

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0220825
    Größe
    Beschrijving

    Height

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0005890
    EKG
    Beschrijving

    ECG

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0220825
    Anamnese
    Beschrijving

    Medical/surgical history

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0455610
    Körperliche Untersuchung
    Beschrijving

    Physical examination

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0031809
    Labor
    Beschrijving

    Laboratory evaluation

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0022885
    Medikamente
    Beschrijving

    Prior/concomitant medication

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0013227
    Schwangerschaftstest
    Beschrijving

    Pregnancy test

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0032976
    Symptom Tagebuch
    Beschrijving

    Dispense Subject Symptom Diary

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2216446
    Aktigraphie
    Beschrijving

    Dispense Actigraphy device

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1171301
    IRLS Beurteilungsskala
    Beschrijving

    IRLS Rating Scale

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0681889
    CGI Beurteilung
    Beschrijving

    CGI Scales (Improvement & Severity)

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3639708
    Insomnie Schweregradindex
    Beschrijving

    Insomnia Severity Index

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0917801
    schriftliche Einwilligungserklärung
    Beschrijving

    Written informed consent

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0021430
    Verbesserung
    Beschrijving

    Dispense Patient Global Improvement Scale (PGI) Forms

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2986411
    UMLS CUI [1,2]
    C0349674
    Zufriedenheitsfragebogen
    Beschrijving

    Patient satisfaction question

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3476649
    Lebensqualität Fragebogen
    Beschrijving

    Quality of Life Questionnaire

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0451149
    Pittsburgh Schlafskala
    Beschrijving

    MOS Sleep Scale

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3697468
    Gemütszustand
    Beschrijving

    Profile of Mood States (POMS)

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0451394
    Krankenhaus Angstskala
    Beschrijving

    Hospital Anxiety and Depression Scale (HADS)

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3539657
    unerwünschtem Ereignis
    Beschrijving

    Adverse events

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0877248
    Randomisierung
    Beschrijving

    Subject randomization

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0034656
    Pharmacogenomics
    Beschrijving

    Pharmacogenomics sample

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1138555
    Schlussfolgerung
    Beschrijving

    Study conclusion form

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1707478
    Terug naar het begin van de pagina

    Similar models

    TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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
    C3539657 (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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