ID

25113

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

Trefwoorden

  1. 26-08-17 26-08-17 -
  2. 17-09-21 17-09-21 -
Houder van rechten

gsk

Geüploaded op

26 augustus 2017

DOI

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Licentie

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

TIME AND EVENTS TABLE
Beschrijving

TIME AND EVENTS TABLE

Assessments
Beschrijving

Assessments

Datatype

integer

Alias
UMLS CUI [1]
C0220825
IRLSSG diagnostic criteria
Beschrijving

IRLSSG diagnostic criteria

Datatype

integer

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

Inclusion/exclusion criteria

Datatype

integer

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

Subject demography

Datatype

integer

Alias
UMLS CUI [1]
C0011298
RLS history
Beschrijving

RLS history

Datatype

integer

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

Orthostatic blood pressure and heart rate

Datatype

integer

Alias
UMLS CUI [1]
C1095971
Weight
Beschrijving

Weight

Datatype

integer

Alias
UMLS CUI [1]
C0220825
Height
Beschrijving

Height

Datatype

integer

Alias
UMLS CUI [1]
C0005890
ECG
Beschrijving

ECG

Datatype

integer

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

Medical/surgical history

Datatype

integer

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

Physical examination

Datatype

integer

Alias
UMLS CUI [1]
C0031809
Laboratory evaluation
Beschrijving

Laboratory evaluation

Datatype

integer

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

Prior/concomitant medication

Datatype

integer

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

Pregnancy test

Datatype

integer

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

Dispense Subject Symptom Diary

Datatype

integer

Alias
UMLS CUI [1]
C2216446
Dispense Actigraphy device
Beschrijving

Dispense Actigraphy device

Datatype

integer

Alias
UMLS CUI [1]
C1171301
IRLS Rating Scale
Beschrijving

IRLS Rating Scale

Datatype

integer

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

CGI Scales (Improvement & Severity)

Datatype

integer

Alias
UMLS CUI [1]
C3639708
Insomnia Severity Index
Beschrijving

Insomnia Severity Index

Datatype

integer

Alias
UMLS CUI [1]
C0917801
Written informed consent
Beschrijving

Written informed consent

Datatype

integer

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

Dispense Patient Global Improvement Scale (PGI) Forms

Datatype

integer

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

Patient satisfaction question

Datatype

integer

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

Quality of Life Questionnaire

Datatype

integer

Alias
UMLS CUI [1]
C0451149
MOS Sleep Scale
Beschrijving

MOS Sleep Scale

Datatype

integer

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

Profile of Mood States (POMS)

Datatype

integer

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

Hospital Anxiety and Depression Scale (HADS)

Datatype

integer

Alias
UMLS CUI [1]
C0451221
Adverse events
Beschrijving

Adverse events

Datatype

integer

Alias
UMLS CUI [1]
C0877248
Subject randomization
Beschrijving

Subject randomization

Datatype

integer

Alias
UMLS CUI [1]
C0034656
Pharmacogenomics sample
Beschrijving

Pharmacogenomics sample

Datatype

integer

Alias
UMLS CUI [1]
C1138555
Study conclusion form
Beschrijving

Study conclusion form

Datatype

integer

Alias
UMLS CUI [1]
C1707478

Similar models

TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
TIME AND EVENTS TABLE
Item
Assessments
integer
C0220825 (UMLS CUI [1])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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
C0451221 (UMLS CUI [1])
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])
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])
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])
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])
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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