ID

24321

Description

Module 6A: Wk 12 to Cont/Wthd 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Keywords

Versions (1)
  1. 7/29/17 7/29/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

July 29, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Week 12

English

GSK study: Ropinirole in RLS patients 101468/243 - Week 12

1 forms  
Study medication record since last visit
Description

Study medication record since last visit

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
Study medication record since last visit
Description

Please complete the study medication record in the Study Medication and Compliance Section at the back of this module.

Data type

text

Alias
UMLS CUI [1,1]
C2734539
UMLS CUI [1,2]
C0008972
RLS Rating scale
Description

RLS Rating scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C0035258
RLS Rating scale
Description

Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Pulse
Description

after 5min sitting

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Sitting systolic blood pressure
Description

after 5 minutes sitting

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting diastolic blood pressure
Description

after 5 minutes sitting

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Medical procedures
Description

Medical procedures

Alias
UMLS CUI-1
C0199171
Medical Procedures
Description

Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this module

Data type

text

Alias
UMLS CUI [1]
C0199171
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Concomitant Medication
Description

Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this module

Data type

text

Alias
UMLS CUI [1]
C2347852
Adverse reaction
Description

Adverse reaction

Alias
UMLS CUI-1
C0559546
Adverse reaction
Description

Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience section at the back of this module

Data type

text

Alias
UMLS CUI [1]
C0559546
Patient rated scale
Description

Patient rated scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C1578483
RLS Quality of Live Questionnaire
Description

If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire

Data type

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0034380
UMLS CUI [1,3]
C0035258
SF36 Health Status Survey
Description

If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire

Data type

text

Alias
UMLS CUI [1]
C3640521
Medical Outcome Study Sleep Scale
Description

If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire

Data type

text

Alias
UMLS CUI [1,1]
C0349674
UMLS CUI [1,2]
C0037313
Work Productivity and Activity Impairment Questionnaire
Description

If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire

Data type

text

Alias
UMLS CUI [1]
C3639722
Healthcare resource utilisation - visits/contacts with physician
Description

Healthcare resource utilisation - visits/contacts with physician

Alias
UMLS CUI-1
C0031831
UMLS CUI-2
C0545082
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
Description

DO NOT INCLUDE ANY WHILE IN HOSPITAL. If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:

Data type

boolean

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0545082
Healthcare resource utilisation - visits/contacts with physician
Description

Healthcare resource utilisation - visits/contacts with physician

Alias
UMLS CUI-1
C0031831
UMLS CUI-2
C0545082
Date of Visit
Description

date of visit physician

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0031831
Type of physician
Description

Type of physician

Data type

integer

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0332307
Visit location
Description

Visit location

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0450429
Was the Visit RLS Related?
Description

A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).

Data type

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Were any tests or procedures prescribed or conducted at this visit?
Description

tests or procedures during visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0039593
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C3274430
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Description

Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners

Alias
UMLS CUI-1
C0030450
UMLS CUI-2
C0545082
In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
Description

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:

Data type

text

Alias
UMLS CUI [1,1]
C0030450
UMLS CUI [1,2]
C0545082
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Description

Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners

Alias
UMLS CUI-1
C0030450
UMLS CUI-2
C0545082
Date of visit
Description

date of visit paramedical practitioner

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0030450
Type of paramedical practitioner
Description

Type of paramedical practitioner

Data type

integer

Alias
UMLS CUI [1]
C0030450
Visit location
Description

Visit location

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0450429
Was the visit RLS related?
Description

A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).

Data type

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Healthcare resource utilisation - Hospitalisation
Description

Healthcare resource utilisation - Hospitalisation

Alias
UMLS CUI-1
C0019993
In the past 4 weeks...was the patient hospitalised?
Description

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each hospitalisation:

Data type

integer

Alias
UMLS CUI [1]
C0019993
Healthcare resource utilisation - hospitalisation
Description

Healthcare resource utilisation - hospitalisation

Alias
UMLS CUI-1
C0019993
Date of admission
Description

date of admission

Data type

date

Alias
UMLS CUI [1]
C1302393
Date of discharge
Description

date of discharge

Data type

date

Alias
UMLS CUI [1]
C2361123
Main reason for stay
Description

Hospitalisation cause

Data type

text

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0392360
Was the Visit RLS Related?
Description

A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.

Data type

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Type of ward
Description

type of ward

Data type

integer

Alias
UMLS CUI [1,1]
C1305702
UMLS CUI [1,2]
C0332307
Length of stay on ward
Description

in days

Data type

durationDatetime

Measurement units
  • days
Alias
UMLS CUI [1,1]
C1305702
UMLS CUI [1,2]
C0023303
days
Healthcare resource utilisation - accident & emergency / emergency room visits
Description

Healthcare resource utilisation - accident & emergency / emergency room visits

Alias
UMLS CUI-1
C0562508
UMLS CUI-2
C0545082
In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
Description

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit

Data type

integer

Alias
UMLS CUI [1,1]
C0562508
UMLS CUI [1,2]
C0545082
Healthcare resource utilisation - accident & emergency / emergency room visits
Description

Healthcare resource utilisation - accident & emergency / emergency room visits

Alias
UMLS CUI-1
C0562508
UMLS CUI-2
C0545082
Date of visit
Description

Date of visit in A&E

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0562508
Was the visit RLS related?
Description

A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.

Data type

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Clinical global impression
Description

Clinical global impression

Alias
UMLS CUI-1
C3639708
Clinical global impression
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

text

Alias
UMLS CUI [1]
C3639708
Instructions for the investigator
Description

Instructions for the investigator

Alias
UMLS CUI-1
C0302828
UMLS CUI-2
C0035173
Instructions for the investigator
Description

Guided by the CGI Efficacy Index (below) determine dose level to be dispensed and dispense Weeks 13 - 24 study medication. Complete the Study Medication and Compliance Section at the back of the next module. If the patient’s dose has been increased at this clinic visit: a) Instruct the patient to return to the clinic this evening or remain to perform orthostatic vital signs*: - 2 sets of pre-dose orthostatic blood pressure and pulse - Patient takes evening dose in the clinic - One set of 2 hour post-dose orthostatic blood pressure and pulse Instruct the patient to take the appropriate number of tablet(s), at the same time, no earlier than 3 hours prior to and no later than one hour prior to bedtime (except on the first night of each new dose increase). Patient must return the bottle(s) with any unused medication at the next visit. Arrange for the patient to return in 84 days (plus or minus 3 days) for the Week 24 clinic visit. * Where possible this visit should be performed in the evening with dosing approximately 8:00 P.M. However, for scheduling convenience, this visit (including dosing) may occur during the afternoon hours (as late in the day as possible) to accomodate the collection of orthostatic blood pressure/pulse assessments during the normal clinic hours.

Data type

text

Clinical Global impression
Description

Clinical Global impression

Alias
UMLS CUI-1
C3639708
Clinical global impression
Description

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

text

Alias
UMLS CUI [1]
C3639708
Dose change between scheduled visits
Description

Dose change between scheduled visits

Alias
UMLS CUI-1
C1707811
Dose change between scheduled visits
Description

If the patient requires a dose change between this and the next visit please complete Dose Changes pages at the back of the next module.

Data type

text

Alias
UMLS CUI [1]
C1707811
Study medication and compliance record
Description

Study medication and compliance record

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
UMLS CUI-3
C1321605
Dose Level
Description

Specify 1 - 8

Data type

integer

Alias
UMLS CUI [1]
C0178602
Date of first dose
Description

First Dose Date

Data type

date

Alias
UMLS CUI [1]
C3173309
Date of last dose
Description

Date last dose

Data type

date

Alias
UMLS CUI [1]
C1762893
Number of tablets dispensed
Description

Number of tablets dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0304229
Number of tablets returned
Description

Number of tablets returned

Data type

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0304229
Dose changes
Description

Dose changes

Alias
UMLS CUI-1
C1707811
Study Medication Week number
Description

Study Medication Week number

Data type

integer

Alias
UMLS CUI [1,1]
C0439230
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0008972
Dose Level
Description

Specify 1 - 8

Data type

integer

Alias
UMLS CUI [1]
C0178602
Date of first dose
Description

First Dose Date

Data type

date

Alias
UMLS CUI [1]
C3173309
Date of last dose
Description

Date last dose

Data type

date

Alias
UMLS CUI [1]
C1762893
Number of tablets dispensed
Description

Number of tablets dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0304229
Number of tablets returned
Description

Number of tablets returned

Data type

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0304229
Medical procedures
Description

Medical procedures

Alias
UMLS CUI-1
C0199171
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed during the module?
Description

If 'Yes', please record details below using standard medical terminology

Data type

integer

Alias
UMLS CUI [1]
C0199171
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0430022
UMLS CUI [4]
C0543467
Medical procedures
Description

Medical procedures

Alias
UMLS CUI-1
C0199171
Procedure
Description

Procedure

Data type

text

Alias
UMLS CUI [1]
C0199171
Indication
Description

All indications for procedures should be recorded in either the Adverse Experiences and/or SAE sections as appropriate.

Data type

text

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C3146298
Procedure Start Date
Description

Procedure Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0808070
End Date Procedure
Description

End Date Procedure

Data type

date

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0806020
Concomitant medication
Description

Concomitant medication

Alias
UMLS CUI-1
C2347852
Please mark with 'yes', if there has been no new or change in concomitant medication during the module
Description

Mark box below or complete page with concomitant medication details (Please print clearly).

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant medication
Description

Concomitant medication

Alias
UMLS CUI-1
C2347852
Drug name (Trade name preferred)
Description

Drug name

Data type

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose
Description

eg. 500 mg

Data type

text

Alias
UMLS CUI [1]
C2348070
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
Description

Any new medical illness/diagnosis (or symptoms in the absence of a diagnosis) should be recorded in the Adverse Experiences and/or SAE sections as appropriate using the same terminology.

Data type

text

Alias
UMLS CUI [1]
C0011900
Start Date (be as precise as possible)
Description

start date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Description

End Date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Does the medication still continue?
Description

If a medication was marked ‘Continuing’ at a previous visit, but has since had a dosage change or has been stopped, it must be recorded as a change below with the new start and end date.

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521116
Adverse experience (non-serious)
Description

Adverse experience (non-serious)

Alias
UMLS CUI-1
C1518404
Please mark this box if no adverse experiences occurred during the module.
Description

Record any adverse experiences (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way since starting the treatment or since the last visit?” Provide the diagnosis, not symptoms, where possible. One adverse experience per column. If you consider this to be a serious adverse experience (SAE), please do not enter on this page but enter in the Serious Adverse Experience (SAE) section (See opposite for definitions of an SAE).

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Adverse experience (non-serious)
Description

Adverse experience (non-serious)

Alias
UMLS CUI-1
C1518404
Adverse experience
Description

Record any adverse experiences (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way since starting the treatment or since the last visit?” Provide the diagnosis, not symptoms, where possible. One adverse experience per column.

Data type

text

Alias
UMLS CUI [1]
C1518404
Onset Date and Time
Description

Adverse Event Start Date Time

Data type

datetime

Alias
UMLS CUI [1]
C2826806
End Date and Time
Description

(If ongoing please leave blank)

Data type

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Description

If patient died, STOP: go to SAE section and follow instructions given there

Data type

integer

Alias
UMLS CUI [1]
C1705586
Experience Course
Description

adverse event course

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Number of episodes
Description

only answer if previous answer was 'intermittent'

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Description

Intensity concerning the maximum

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Action Taken with Respect to Investigational Drug
Description

Action Taken with Respect to Investigational Drug

Data type

integer

Alias
UMLS CUI [1]
C2826626
Relationship to Investigational Drug
Description

Relationship to Investigational Drug

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Corrective Therapy
Description

f ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific AE?
Description

Was patient withdrawn due to this specific AE?

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Pregnancy information
Description

Pregnancy information

Alias
UMLS CUI-1
C0032961
Has the patient become pregnant to date?
Description

If ’Yes’ please record details on the Pregnancy Notification Form, if not already completed and withdraw the patient.

Data type

text

Alias
UMLS CUI [1]
C0032961
Patient continuation/ withdrawal
Description

Patient continuation/ withdrawal

Alias
UMLS CUI-1
C2348568
Is the patient continuing in the study?
Description

If ’No’, please mark the primary cause of withdrawal.

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0549178
Cause of withdrawal from study
Description

Cause of withdrawal from study

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0085978
Please specify 'other' cause of withdrawal from study.
Description

Other cause of withdrawal from study

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0205394
Investigator signature
Description

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator signature
Description

I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Adverse Experience and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.

Data type

text

Alias
UMLS CUI [1]
C2346576
Date of Investigator signature
Description

Investigator signature date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

GSK study: Ropinirole in RLS patients 101468/243 - Week 12

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study medication record since last visit
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Study medication record since last visit
Item
Study medication record since last visit
text
C2734539 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Item Group
RLS Rating scale
C0681889 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
RLS Rating scale
Item
RLS Rating scale
text
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Pulse rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Sitting systolic blood pressure
Item
Sitting systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting diastolic blood pressure
Item
Sitting diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Medical procedures
C0199171 (UMLS CUI-1)
Medical Procedures
Item
Medical Procedures
text
C0199171 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Concomitant Medication
text
C2347852 (UMLS CUI [1])
Item Group
Adverse reaction
C0559546 (UMLS CUI-1)
Adverse reaction
Item
Adverse reaction
text
C0559546 (UMLS CUI [1])
Item Group
Patient rated scale
C0681889 (UMLS CUI-1)
C1578483 (UMLS CUI-2)
RLS Quality of Live Questionnaire
Item
RLS Quality of Live Questionnaire
text
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
SF36 Health Status Survey
Item
SF36 Health Status Survey
text
C3640521 (UMLS CUI [1])
Medical Outcome Study Sleep Scale
Item
Medical Outcome Study Sleep Scale
text
C0349674 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
Work Productivity and Activity Impairment Questionnaire
Item
Work Productivity and Activity Impairment Questionnaire
text
C3639722 (UMLS CUI [1])
Item Group
Healthcare resource utilisation - visits/contacts with physician
C0031831 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
visit physician in the last 4 weeks
Item
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
boolean
C0031831 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Item Group
Healthcare resource utilisation - visits/contacts with physician
C0031831 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
date of visit physician
Item
Date of Visit
date
C1320303 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Item
Type of physician
integer
C0031831 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of physician
Code List
Type of physician
CL Item
Cardiologist (1)
CL Item
Diabetologist (2)
CL Item
Dermatologist (3)
CL Item
Endocrinologist (4)
CL Item
ENT (Ear Nose & Throat) (5)
CL Item
Gastroenterologist (6)
CL Item
General/Internal Medical (7)
CL Item
General Practitioner/Family Practitioner  (8)
CL Item
Geriatrician (9)
CL Item
Gynaecologist (10)
CL Item
Infectious Disease (11)
CL Item
Nephrologist (12)
CL Item
Neurologist (13)
CL Item
Psychiatrist (14)
CL Item
Orthopaedic (15)
CL Item
Oncologist (16)
CL Item
Ophthalmologist (17)
CL Item
Respiratory/Chest Physician  (18)
CL Item
Rheumatologist (19)
CL Item
Urologist (20)
CL Item
Sleep Disorder Specialist  (21)
CL Item
Other (99)
Item
Visit location
integer
C0545082 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Visit location
Code List
Visit location
CL Item
Non hospital Office visit (eg GP surgery, Specialist's office etc) (1)
CL Item
Hospital Out Patient visit (2)
CL Item
At the Patient's home / domiciliary visit (3)
Item
Was the Visit RLS Related?
integer
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the Visit RLS Related?
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item
Were any tests or procedures prescribed or conducted at this visit?
text
C0545082 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0545082 (UMLS CUI [2,1])
C3274430 (UMLS CUI [2,2])
tests or procedures during visit
Code List
Were any tests or procedures prescribed or conducted at this visit?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item Group
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
C0030450 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Item
In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
text
C0030450 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Paramedical Practitioner
Code List
In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
CL Item
no (1)
CL Item
yes (2)
Item Group
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
C0030450 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
date of visit paramedical practitioner
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C0030450 (UMLS CUI [1,2])
Item
Type of paramedical practitioner
integer
C0030450 (UMLS CUI [1])
Type of paramedical practitioner
Code List
Type of paramedical practitioner
CL Item
Acupuncturist (1)
CL Item
Chiropodist/ Footcare Practitioner (2)
CL Item
Chiropractor (3)
CL Item
Dentist (4)
CL Item
Dietician (5)
CL Item
Homeopath/Herbalist (6)
CL Item
Nurse (7)
CL Item
Osteopath (8)
CL Item
Physiotherapist (9)
CL Item
Other (99)
Item
Visit location
integer
C0545082 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Visit location
Code List
Visit location
CL Item
Non hospital Office visit (1)
CL Item
Hospital Out Patient visit (2)
CL Item
At the Patient's home / domiciliary visit (3)
Item
Was the visit RLS related?
integer
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the visit RLS related?
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item Group
Healthcare resource utilisation - Hospitalisation
C0019993 (UMLS CUI-1)
Item
In the past 4 weeks...was the patient hospitalised?
integer
C0019993 (UMLS CUI [1])
Hospitalisation
Code List
In the past 4 weeks...was the patient hospitalised?
CL Item
no (1)
CL Item
yes (2)
Item Group
Healthcare resource utilisation - hospitalisation
C0019993 (UMLS CUI-1)
date of admission
Item
Date of admission
date
C1302393 (UMLS CUI [1])
date of discharge
Item
Date of discharge
date
C2361123 (UMLS CUI [1])
Hospitalisation cause
Item
Main reason for stay
text
C0019993 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item
Was the Visit RLS Related?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the Visit RLS Related?
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item
Type of ward
integer
C1305702 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
type of ward
Code List
Type of ward
CL Item
Cardiovascular (1)
CL Item
Dermatological (2)
CL Item
Endocrinological (3)
CL Item
ENT (Ear, Nose & Throat)  (4)
CL Item
Gastroenterological (5)
CL Item
General Medical (6)
CL Item
Geriatric (7)
CL Item
Gynaecological (8)
CL Item
Infectious Disease  (9)
CL Item
Nephrological (10)
CL Item
Intensive Care  (11)
CL Item
Neurological  (12)
CL Item
Psychiatric (13)
CL Item
Orthopaedic  (14)
CL Item
Oncology (15)
CL Item
Ophthalmological  (16)
CL Item
Respiratory/Chest  (17)
CL Item
Rheumatological  (18)
CL Item
Urological (19)
CL Item
Other (99)
length of stay on ward
Item
Length of stay on ward
durationDatetime
C1305702 (UMLS CUI [1,1])
C0023303 (UMLS CUI [1,2])
Item Group
Healthcare resource utilisation - accident & emergency / emergency room visits
C0562508 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Item
In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
integer
C0562508 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
A&E visits
Code List
In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
CL Item
no (1)
CL Item
yes (2)
Item Group
Healthcare resource utilisation - accident & emergency / emergency room visits
C0562508 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Date of visit in A&E
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C0562508 (UMLS CUI [1,2])
Item
Was the visit RLS related?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the visit RLS related?
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item Group
Clinical global impression
C3639708 (UMLS CUI-1)
Clinical global impression
Item
Clinical global impression
text
C3639708 (UMLS CUI [1])
Item Group
Instructions for the investigator
C0302828 (UMLS CUI-1)
C0035173 (UMLS CUI-2)
Instructions for the investigator
Item
Instructions for the investigator
text
Item Group
Clinical Global impression
C3639708 (UMLS CUI-1)
Clinical global impression
Item
Clinical global impression
text
C3639708 (UMLS CUI [1])
Item Group
Dose change between scheduled visits
C1707811 (UMLS CUI-1)
Dose modification
Item
Dose change between scheduled visits
text
C1707811 (UMLS CUI [1])
Item Group
Study medication and compliance record
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C1321605 (UMLS CUI-3)
Dose Level
Item
Dose Level
integer
C0178602 (UMLS CUI [1])
First Dose Date
Item
Date of first dose
date
C3173309 (UMLS CUI [1])
Date last dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
Number of tablets dispensed
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Dose changes
C1707811 (UMLS CUI-1)
Study Medication Week number
Item
Study Medication Week number
integer
C0439230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Dose Level
Item
Dose Level
integer
C0178602 (UMLS CUI [1])
First Dose Date
Item
Date of first dose
date
C3173309 (UMLS CUI [1])
Date last dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
Number of tablets dispensed
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
Medical procedures
C0199171 (UMLS CUI-1)
Item
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed during the module?
integer
C0199171 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0430022 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
medical procedures
Code List
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed during the module?
CL Item
no (1)
CL Item
yes (2)
Item Group
Medical procedures
C0199171 (UMLS CUI-1)
Procedure
Item
Procedure
text
C0199171 (UMLS CUI [1])
Indication of medical procedure
Item
Indication
text
C0199171 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Procedure Start Date
Item
Procedure Start Date
date
C0199171 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date Procedure
Item
End Date Procedure
date
C0199171 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Concomitant medication
Item
Please mark with 'yes', if there has been no new or change in concomitant medication during the module
boolean
C2347852 (UMLS CUI [1])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Drug name
Item
Drug name (Trade name preferred)
text
C0013227 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1])
start date of medication
Item
Start Date (be as precise as possible)
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of medication
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
medication is current
Item
Does the medication still continue?
boolean
C0013227 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Item Group
Adverse experience (non-serious)
C1518404 (UMLS CUI-1)
Non-serious adverse event
Item
Please mark this box if no adverse experiences occurred during the module.
boolean
C1518404 (UMLS CUI [1])
Item Group
Adverse experience (non-serious)
C1518404 (UMLS CUI-1)
Non-serious adverse event
Item
Adverse experience
text
C1518404 (UMLS CUI [1])
Adverse Event Start Date Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
Adverse Event End Date Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Outcome
CL Item
resolved (1)
CL Item
ongoing (2)
CL Item
died (3)
Item
Experience Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
adverse event course
Code List
Experience Course
CL Item
intermittent (1)
CL Item
constant (2)
Number of episodes of adverse event
Item
Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of the adverse event
Code List
Intensity (maximum)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Action Taken with Respect to Investigational Drug
Code List
Action Taken with Respect to Investigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped (5)
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship to Investigational Drug
Code List
Relationship to Investigational Drug
CL Item
Related (5)
CL Item
Possibly related (6)
CL Item
Probably unrelated (7)
CL Item
Unrelated (1)
Item
Corrective Therapy
integer
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Corrective therapy to adverse event
Code List
Corrective Therapy
CL Item
yes (1)
CL Item
no (2)
Was patient withdrawn due to this specific AE?
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
Item
Has the patient become pregnant to date?
text
C0032961 (UMLS CUI [1])
pregnancy
Code List
Has the patient become pregnant to date?
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Patient continuation/ withdrawal
C2348568 (UMLS CUI-1)
Continuing study
Item
Is the patient continuing in the study?
boolean
C0008976 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
Cause of withdrawal from study
integer
C0422727 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Cause of withdrawal from study
Code List
Cause of withdrawal from study
CL Item
Adverse experience (please complete AE page) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other-specify (7)
Other cause of withdrawal from study
Item
Please specify 'other' cause of withdrawal from study.
text
C0422727 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Date of Investigator signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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