ID

29071

Description

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

Keywords

Versions (1)
  1. 2/23/18 2/23/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

February 23, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857

English

Significant medical/surgical history, physical examination and medication

1 forms  
Medical/Surgical condition
Description

Medical/Surgical condition

Alias
UMLS CUI-1
C0543467
UMLS CUI-3
C0012634
Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition?
Description

If ’Yes’ , please list below one diagnosis per line. (Please print clearly)

Data type

text

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C0012634
Medical/Surgical condition
Description

Medical/Surgical condition

Alias
UMLS CUI-1
C0543467
UMLS CUI-3
C0012634
Diagnosis
Description

Only in the absence of a diagnosis, record the signs and symptoms on separate lines.

Data type

text

Alias
UMLS CUI [1]
C0011900
Year of first diagnosis (if known)
Description

Year of first diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0439234
Past or Ongoing
Description

Past or Ongoing

Data type

integer

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C1444637
UMLS CUI [2,2]
C0012634
Prior and concomitant medication
Description

Prior and concomitant medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-3
C2347852
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?
Description

If ‘Yes’, please record details below (Please print clearly)

Data type

text

Alias
UMLS CUI [1]
C2826257
UMLS CUI [2]
C2347852
Prior and concomitant medication
Description

Prior and concomitant medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Drug Name (Trade Name Preferred)
Description

Drug Name

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Total Daily Dose (eg 500mg)
Description

Total Daily Dose

Data type

integer

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Medical Illness/Diagnosis (or symptom in absence of diagnosis)
Description

Medical Illness/Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C3146298
Start Date (be as precise as possible)
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date (or if Continuing mark box)
Description

End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
If continuing mark box:
Description

Continuing medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
RLS Pharmacotherapy history
Description

RLS Pharmacotherapy history

Alias
UMLS CUI-1
C0013216
UMLS CUI-2
C0035258
Has the patient taken any pharmacotherapy medication for treatment of RLS?
Description

If ‘Yes’, please record details below (Please print clearly)

Data type

text

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0035258
RLS Pharmacotherapy history
Description

RLS Pharmacotherapy history

Alias
UMLS CUI-1
C0013216
UMLS CUI-2
C0035258
Drug Name (Trade Name Preferred)
Description

Drug Name

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Start Date (be as precise as possible)
Description

Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date (or if Continuing mark box)
Description

End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
If continuing mark box:
Description

Continuing medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Did the patient respond to the treatment? (mark one)
Description

Treatment response

Data type

integer

Alias
UMLS CUI [1]
C0521982
Did the patient tolerate the treatment? (mark one)
Description

Treatment toleration

Data type

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0680282
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Similar models

Significant medical/surgical history, physical examination and medication

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Medical/Surgical condition
C0543467 (UMLS CUI-1)
C0012634 (UMLS CUI-3)
Item
Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition?
text
C0543467 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
medical or surgical condition
Code List
Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Medical/Surgical condition
C0543467 (UMLS CUI-1)
C0012634 (UMLS CUI-3)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis
Item
Year of first diagnosis (if known)
integer
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Item
Past or Ongoing
integer
C0549178 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1444637 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
Past or Ongoing
Code List
Past or Ongoing
CL Item
Past (1)
CL Item
Ongoing (2)
CL Item
Past + Ongoing (3)
Item Group
Prior and concomitant medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
Item
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?
text
C2826257 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Prior and concomitant medication
Code List
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Prior and concomitant medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug Name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose (eg 500mg)
integer
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Illness/Diagnosis
Item
Medical Illness/Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Start Date
Item
Start Date (be as precise as possible)
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date
Item
End Date (or if Continuing mark box)
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Continuing medication
Item
If continuing mark box:
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
RLS Pharmacotherapy history
C0013216 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
Item
Has the patient taken any pharmacotherapy medication for treatment of RLS?
text
C0013216 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
RLS pharmacotherapy
Code List
Has the patient taken any pharmacotherapy medication for treatment of RLS?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
RLS Pharmacotherapy history
C0013216 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
Drug Name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Start Date
Item
Start Date (be as precise as possible)
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date
Item
End Date (or if Continuing mark box)
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Continuing medication
Item
If continuing mark box:
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
Did the patient respond to the treatment? (mark one)
integer
C0521982 (UMLS CUI [1])
Treatment response
Code List
Did the patient respond to the treatment? (mark one)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Did the patient tolerate the treatment? (mark one)
integer
C0087111 (UMLS CUI [1,1])
C0680282 (UMLS CUI [1,2])
Treatment toleration
Code List
Did the patient tolerate the treatment? (mark one)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
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