ID

42909

Descrição

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

Palavras-chave

Versões (2)
  1. 26/08/2017 26/08/2017 -
  2. 17/09/2021 17/09/2021 -
Titular dos direitos

gsk

Transferido a

17 de setembro de 2021

DOI

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Licença

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

Alemão Inglês

TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

1 Formulários  
TIME AND EVENTS TABLE
Descrição

TIME AND EVENTS TABLE

Assessments
Descrição

Assessments

Tipo de dados

integer

Alias
UMLS CUI [1]
C0220825
IRLSSG diagnostic criteria
Descrição

IRLSSG diagnostic criteria

Tipo de dados

integer

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

Inclusion/exclusion criteria

Tipo de dados

integer

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

Subject demography

Tipo de dados

integer

Alias
UMLS CUI [1]
C0011298
RLS history
Descrição

RLS history

Tipo de dados

integer

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

Orthostatic blood pressure and heart rate

Tipo de dados

integer

Alias
UMLS CUI [1]
C1095971
Weight
Descrição

Weight

Tipo de dados

integer

Alias
UMLS CUI [1]
C0220825
Height
Descrição

Height

Tipo de dados

integer

Alias
UMLS CUI [1]
C0005890
ECG
Descrição

ECG

Tipo de dados

integer

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

Medical/surgical history

Tipo de dados

integer

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

Physical examination

Tipo de dados

integer

Alias
UMLS CUI [1]
C0031809
Laboratory evaluation
Descrição

Laboratory evaluation

Tipo de dados

integer

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

Prior/concomitant medication

Tipo de dados

integer

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

Pregnancy test

Tipo de dados

integer

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

Dispense Subject Symptom Diary

Tipo de dados

integer

Alias
UMLS CUI [1]
C2216446
Dispense Actigraphy device
Descrição

Dispense Actigraphy device

Tipo de dados

integer

Alias
UMLS CUI [1]
C1171301
IRLS Rating Scale
Descrição

IRLS Rating Scale

Tipo de dados

integer

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

CGI Scales (Improvement & Severity)

Tipo de dados

integer

Alias
UMLS CUI [1]
C3639708
Insomnia Severity Index
Descrição

Insomnia Severity Index

Tipo de dados

integer

Alias
UMLS CUI [1]
C0917801
Written informed consent
Descrição

Written informed consent

Tipo de dados

integer

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

Dispense Patient Global Improvement Scale (PGI) Forms

Tipo de dados

integer

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

Patient satisfaction question

Tipo de dados

integer

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

Quality of Life Questionnaire

Tipo de dados

integer

Alias
UMLS CUI [1]
C0451149
MOS Sleep Scale
Descrição

MOS Sleep Scale

Tipo de dados

integer

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

Profile of Mood States (POMS)

Tipo de dados

integer

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

Hospital Anxiety and Depression Scale (HADS)

Tipo de dados

integer

Alias
UMLS CUI [1]
C3539657
Adverse events
Descrição

Adverse events

Tipo de dados

integer

Alias
UMLS CUI [1]
C0877248
Subject randomization
Descrição

Subject randomization

Tipo de dados

integer

Alias
UMLS CUI [1]
C0034656
Pharmacogenomics sample
Descrição

Pharmacogenomics sample

Tipo de dados

integer

Alias
UMLS CUI [1]
C1138555
Study conclusion form
Descrição

Study conclusion form

Tipo de dados

integer

Alias
UMLS CUI [1]
C1707478
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TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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