0 Evaluaciones

ID

42909

Descripción

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

Palabras clave

  1. 26/8/17 26/8/17 -
  2. 17/9/21 17/9/21 -
Titular de derechos de autor

gsk

Subido en

17 de septiembre de 2021

DOI

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Licencia

Creative Commons BY-NC 3.0

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    TIME AND EVENTS TABLE Ropinirole Case Report Form GSK RRL100013

    TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

    Zeitplan
    Descripción

    Zeitplan

    Bewertung
    Descripción

    Assessments

    Tipo de datos

    integer

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

    IRLSSG diagnostic criteria

    Tipo de datos

    integer

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

    Inclusion/exclusion criteria

    Tipo de datos

    integer

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

    Subject demography

    Tipo de datos

    integer

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

    RLS history

    Tipo de datos

    integer

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

    Orthostatic blood pressure and heart rate

    Tipo de datos

    integer

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

    Weight

    Tipo de datos

    integer

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

    Height

    Tipo de datos

    integer

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

    ECG

    Tipo de datos

    integer

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

    Medical/surgical history

    Tipo de datos

    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
    Descripción

    Physical examination

    Tipo de datos

    integer

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

    Laboratory evaluation

    Tipo de datos

    integer

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

    Prior/concomitant medication

    Tipo de datos

    integer

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

    Pregnancy test

    Tipo de datos

    integer

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

    Dispense Subject Symptom Diary

    Tipo de datos

    integer

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

    Dispense Actigraphy device

    Tipo de datos

    integer

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

    IRLS Rating Scale

    Tipo de datos

    integer

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

    CGI Scales (Improvement & Severity)

    Tipo de datos

    integer

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

    Insomnia Severity Index

    Tipo de datos

    integer

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

    Written informed consent

    Tipo de datos

    integer

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

    Dispense Patient Global Improvement Scale (PGI) Forms

    Tipo de datos

    integer

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

    Patient satisfaction question

    Tipo de datos

    integer

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

    Quality of Life Questionnaire

    Tipo de datos

    integer

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

    MOS Sleep Scale

    Tipo de datos

    integer

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

    Profile of Mood States (POMS)

    Tipo de datos

    integer

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

    Hospital Anxiety and Depression Scale (HADS)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C3539657 (Hospital Anxiety and Depression Scale Questionnaire)
    SNOMED
    273524006
    unerwünschtem Ereignis
    Descripción

    Adverse events

    Tipo de datos

    integer

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

    Subject randomization

    Tipo de datos

    integer

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

    Pharmacogenomics sample

    Tipo de datos

    integer

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

    Study conclusion form

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1707478 (Conclusion)

    Similar models

    TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Zeitplan
    Item
    Bewertung
    integer
    C0220825 (UMLS CUI [1])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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])
    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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