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ID

42909

Description

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

Keywords

Versions (2)
  1. 8/26/17 8/26/17 -
  2. 9/17/21 9/17/21 -
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gsk

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September 17, 2021

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Creative Commons BY-NC 3.0
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    TIME AND EVENTS TABLE Ropinirole Case Report Form GSK RRL100013

    German English

    TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

    1 forms  
    TIME AND EVENTS TABLE
    Description

    TIME AND EVENTS TABLE

    Assessments
    Description

    Assessments

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0220825
    IRLSSG diagnostic criteria
    Description

    IRLSSG diagnostic criteria

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C2348561
    Inclusion/exclusion criteria
    Description

    Inclusion/exclusion criteria

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0680251
    Subject demography
    Description

    Subject demography

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0011298
    RLS history
    Description

    RLS history

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0035258
    Orthostatic blood pressure and heart rate
    Description

    Orthostatic blood pressure and heart rate

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1095971
    Weight
    Description

    Weight

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0220825
    Height
    Description

    Height

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0005890
    ECG
    Description

    ECG

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0220825
    Medical/surgical history
    Description

    Medical/surgical history

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0455610
    Physical examination
    Description

    Physical examination

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031809
    Laboratory evaluation
    Description

    Laboratory evaluation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0022885
    Prior/concomitant medication
    Description

    Prior/concomitant medication

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0013227
    Pregnancy test
    Description

    Pregnancy test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0032976
    Dispense Subject Symptom Diary
    Description

    Dispense Subject Symptom Diary

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2216446
    Dispense Actigraphy device
    Description

    Dispense Actigraphy device

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1171301
    IRLS Rating Scale
    Description

    IRLS Rating Scale

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0681889
    CGI Scales (Improvement & Severity)
    Description

    CGI Scales (Improvement & Severity)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3639708
    Insomnia Severity Index
    Description

    Insomnia Severity Index

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0917801
    Written informed consent
    Description

    Written informed consent

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0021430
    Dispense Patient Global Improvement Scale (PGI) Forms
    Description

    Dispense Patient Global Improvement Scale (PGI) Forms

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2986411
    UMLS CUI [1,2]
    C0349674
    Patient satisfaction question
    Description

    Patient satisfaction question

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3476649
    Quality of Life Questionnaire
    Description

    Quality of Life Questionnaire

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0451149
    MOS Sleep Scale
    Description

    MOS Sleep Scale

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3697468
    Profile of Mood States (POMS)
    Description

    Profile of Mood States (POMS)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0451394
    Hospital Anxiety and Depression Scale (HADS)
    Description

    Hospital Anxiety and Depression Scale (HADS)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3539657
    Adverse events
    Description

    Adverse events

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0877248
    Subject randomization
    Description

    Subject randomization

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0034656
    Pharmacogenomics sample
    Description

    Pharmacogenomics sample

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1138555
    Study conclusion form
    Description

    Study conclusion form

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1707478
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    Similar models

    TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    TIME AND EVENTS TABLE
    Item
    Assessments
    integer
    C0220825 (UMLS CUI [1])
    Assessments
    Code List
    Assessments
    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 diagnostic criteria
    integer
    C0035258 (UMLS CUI [1,1])
    C2348561 (UMLS CUI [1,2])
    Assessments
    Code List
    IRLSSG diagnostic criteria
    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
    Inclusion/exclusion criteria
    integer
    C1512693 (UMLS CUI [1,1])
    C0680251 (UMLS CUI [1,2])
    Assessments
    Code List
    Inclusion/exclusion criteria
    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
    Subject demography
    integer
    C0011298 (UMLS CUI [1])
    Assessments
    Code List
    Subject demography
    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
    RLS history
    integer
    C0035258 (UMLS CUI [1])
    Assessments
    Code List
    RLS history
    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
    Orthostatic blood pressure and heart rate
    integer
    C1095971 (UMLS CUI [1])
    Assessments
    Code List
    Orthostatic blood pressure and heart rate
    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
    Weight
    integer
    C0220825 (UMLS CUI [1])
    Assessments
    Code List
    Weight
    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
    Height
    integer
    C0005890 (UMLS CUI [1])
    Assessments
    Code List
    Height
    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
    ECG
    integer
    C0220825 (UMLS CUI [1])
    Assessments
    Code List
    ECG
    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
    Medical/surgical history
    integer
    C0262926 (UMLS CUI [1,1])
    C0455610 (UMLS CUI [1,2])
    Assessments
    Code List
    Medical/surgical history
    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
    Physical examination
    integer
    C0031809 (UMLS CUI [1])
    Assessments
    Code List
    Physical examination
    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
    Laboratory evaluation
    integer
    C0022885 (UMLS CUI [1])
    Assessments
    Code List
    Laboratory evaluation
    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
    Prior/concomitant medication
    integer
    C2347852 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Assessments
    Code List
    Prior/concomitant medication
    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
    Pregnancy test
    integer
    C0032976 (UMLS CUI [1])
    Assessments
    Code List
    Pregnancy test
    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
    Dispense Subject Symptom Diary
    integer
    C2216446 (UMLS CUI [1])
    Assessments
    Code List
    Dispense Subject Symptom Diary
    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
    Dispense Actigraphy device
    integer
    C1171301 (UMLS CUI [1])
    Assessments
    Code List
    Dispense Actigraphy device
    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 Rating Scale
    integer
    C0681889 (UMLS CUI [1])
    Assessments
    Code List
    IRLS Rating Scale
    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 Scales (Improvement & Severity)
    integer
    C3639708 (UMLS CUI [1])
    Assessments
    Code List
    CGI Scales (Improvement & Severity)
    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
    Insomnia Severity Index
    integer
    C0917801 (UMLS CUI [1])
    Assessments
    Code List
    Insomnia Severity Index
    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
    Written informed consent
    integer
    C0021430 (UMLS CUI [1])
    Assessments
    Code List
    Written informed consent
    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
    Dispense Patient Global Improvement Scale (PGI) Forms
    integer
    C2986411 (UMLS CUI [1,1])
    C0349674 (UMLS CUI [1,2])
    Assessments
    Code List
    Dispense Patient Global Improvement Scale (PGI) Forms
    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
    Patient satisfaction question
    integer
    C3476649 (UMLS CUI [1])
    Assessments
    Code List
    Patient satisfaction question
    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
    Quality of Life Questionnaire
    integer
    C0451149 (UMLS CUI [1])
    Assessments
    Code List
    Quality of Life Questionnaire
    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
    MOS Sleep Scale
    integer
    C3697468 (UMLS CUI [1])
    Assessments
    Code List
    MOS Sleep Scale
    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
    Profile of Mood States (POMS)
    integer
    C0451394 (UMLS CUI [1])
    Assessments
    Code List
    Profile of Mood States (POMS)
    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
    Hospital Anxiety and Depression Scale (HADS)
    integer
    C3539657 (UMLS CUI [1])
    Assessments
    Code List
    Hospital Anxiety and Depression Scale (HADS)
    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
    Adverse events
    integer
    C0877248 (UMLS CUI [1])
    Assessments
    Code List
    Adverse events
    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
    Subject randomization
    integer
    C0034656 (UMLS CUI [1])
    Assessments
    Code List
    Subject randomization
    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 sample
    integer
    C1138555 (UMLS CUI [1])
    Assessments
    Code List
    Pharmacogenomics sample
    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
    Study conclusion form
    integer
    C1707478 (UMLS CUI [1])
    Assessments
    Code List
    Study conclusion form
    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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