ID

35625

Description

Study ID: 101468/192 Clinical Study ID: 101468/192 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: 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 The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the Health Care Resource Utilisation form. It has to be filled in for Baseline/Screening, Week 12-48 and for early withdrawal.

Keywords

Versions (1)
  1. 3/12/19 3/12/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 12, 2019

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License

Creative Commons BY-NC 3.0
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Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192

English

Health Care Resource Utilisation

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Health Care Resource Utilisation
Description

Health Care Resource Utilisation

Alias
UMLS CUI-1
C1704738
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
Description

This series of questions concerns visits and contacts between you (the physician) or other physicians and this particular patient in the past 4 weeks. A visit is defined as any contact or consultation where you have spent time with the patient. This may include visits where repeat prescriptions have been given but you have also spent time reviewing the patient or discussing their condition. DO NOT INCLUDE ANY WHILE IN HOSPITAL.

Data type

text

Alias
UMLS CUI [1]
C1704738
Date of Visit or Contact
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Type of Physician visited
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

Select one of the 3 descriptions below to indicate the relation of the visit to RLS: 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

integer

Alias
UMLS CUI [1]
C1704447
Were any Tests or procedures prescribed or conducted at this visit?
Description

medical procedure

Data type

text

Alias
UMLS CUI [1]
C0199171
Visit Paramedical Practitioners
Description

Visit Paramedical Practitioners

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

This series of questions concerns visits or contacts between Paramedical Practitioners and the patient in the past 4 weeks

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0030450
Date of Visit or Contact
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Type of Paramedical Practitioner visited
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

Select one of the 3 descriptions below to indicate the relation of the visit to RLS: 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

integer

Alias
UMLS CUI [1]
C1704447
Hospitalization
Description

Hospitalization

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

Hospitalization

Data type

text

Alias
UMLS CUI [1]
C0019993
Date of Admission
Description

day month year. You are asked to provide the date of admission and the date of discharge. Please ensure that the total of days spent in wards equals the total number of days spent in the hospital (Date of discharge - date admitted).

Data type

date

Alias
UMLS CUI [1]
C1302393
Date of Discharge
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2361123
Main Reason for Stay
Description

Main Reason for Stay

Data type

text

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

Please give an indication of the main reason for the patient’s hospitalisation and whether or not this hospitalisation is related to the patient’s RLS condition. Select one of the 3 descriptions below to indicate the relation of the visit to RLS: 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

integer

Alias
UMLS CUI [1]
C1704447
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

Length of Stay

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1]
C0023303
days
emergency room admission
Description

emergency room admission

Alias
UMLS CUI-1
C0583237
In the past 4 weeks…did the patient visit an Accident and Emergency or EMERGENCY ROOM?
Description

Please record all visits to Accident and Emergency Departments or Emergency Rooms, for this patient, in the past 4 weeks.

Data type

text

Alias
UMLS CUI [1]
C0583237
Date of Visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Was the Visit RLS Related?
Description

Select one of the 3 descriptions below to indicate the relation of the visit to RLS: 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

integer

Alias
UMLS CUI [1]
C1704447
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Similar models

Health Care Resource Utilisation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Baseline (Screening)  (1)
CL Item
Week 12 (2)
CL Item
Week 24 (3)
CL Item
Week 36 (4)
CL Item
Week 48 (5)
CL Item
Early withdrawal (6)
Item Group
Health Care Resource Utilisation
C1704738 (UMLS CUI-1)
Item
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
text
C1704738 (UMLS CUI [1])
Health Care Resource Utilisation
Code List
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
CL Item
Yes (Y)
CL Item
No (N)
Date of Visit
Item
Date of Visit or Contact
date
C1320303 (UMLS CUI [1])
Item
Type of Physician visited
integer
C0031831 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Physician
Code List
Type of Physician visited
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
C1704447 (UMLS CUI [1])
visit reason
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
C0199171 (UMLS CUI [1])
medical procedure
Code List
Were any Tests or procedures prescribed or conducted at this visit?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item Group
Visit Paramedical Practitioners
C0545082 (UMLS CUI-1)
C0030450 (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
C0545082 (UMLS CUI [1,1])
C0030450 (UMLS CUI [1,2])
Visit Paramedical Practitioners
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
Yes (Y)
CL Item
No (N)
Date of Visit
Item
Date of Visit or Contact
date
C1320303 (UMLS CUI [1])
Item
Type of Paramedical Practitioner visited
integer
C0030450 (UMLS CUI [1])
Type of Paramedical Practitioner
Code List
Type of Paramedical Practitioner visited
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
C1704447 (UMLS CUI [1])
undefined item
Code List
Was the Visit RLS Related?
CL Item
Directly (1)
CL Item
Indirectly (2)
CL Item
Not related (3)
Item Group
Hospitalization
C0019993 (UMLS CUI-1)
Item
In the past 4 weeks…was the patient hospitalised?
text
C0019993 (UMLS CUI [1])
Hospitalization
Code List
In the past 4 weeks…was the patient hospitalised?
CL Item
Yes (Y)
CL Item
No (N)
Date of Admission
Item
Date of Admission
date
C1302393 (UMLS CUI [1])
Date of Discharge
Item
Date of Discharge
date
C2361123 (UMLS CUI [1])
Main Reason for Stay
Item
Main Reason for Stay
text
C0019993 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item
Was the Visit RLS Related?
integer
C1704447 (UMLS CUI [1])
undefined item
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
Item
Length of Stay on Ward
integer
C0023303 (UMLS CUI [1])
Item Group
emergency room admission
C0583237 (UMLS CUI-1)
Item
In the past 4 weeks…did the patient visit an Accident and Emergency or EMERGENCY ROOM?
text
C0583237 (UMLS CUI [1])
emergency room admission
Code List
In the past 4 weeks…did the patient visit an Accident and Emergency or EMERGENCY ROOM?
CL Item
Yes (Y)
CL Item
No (N)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Was the Visit RLS Related?
integer
C1704447 (UMLS CUI [1])
undefined item
Code List
Was the Visit RLS Related?
CL Item
Directly (1)
CL Item
Indirectly (2)
CL Item
Not related (3)
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