ID

29114

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. 2/26/18 2/26/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

February 26, 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

Study medication and compliance record

1 forms  
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Patient number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Center Number
Description

Center Number

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Study medication
Description

Study medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0304229
UMLS CUI-3
C0008976
UMLS CUI-4
C0035258
Study Med. Week No.
Description

Study Medication Week No.

Data type

integer

Alias
UMLS CUI [1]
C0439230
Is this a Dose Reduction?
Description

If ’Yes’, please complete the Dose Reductions due to AE on page 95. Do not continue on this page for this visit.

Data type

boolean

Alias
UMLS CUI [1]
C1707814
Dose Level (Specify 1 - 8)
Description

Dose level

Data type

integer

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

Date of first dose

Data type

date

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

Date of 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]
C0039225
Number of tablets returned
Description

Number of tablets returned

Data type

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Interruption of ≥ 2 consecutive days?
Description

Interruption

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1512900
Dose Reduction due to adverse experiences
Description

Dose Reduction due to adverse experiences

Alias
UMLS CUI-1
C1707814
UMLS CUI-2
C0559546
Study Med. Week No. (Specify)
Description

Study Med. Week No.

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0439230
Dose level (specify)
Description

Dose level

Data type

integer

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

Date of first dose

Data type

date

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

Date of 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]
C0039225
Number of tablets returned
Description

Number of tablets returned

Data type

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Interruption of 2 consecutive days?
Description

Interruption

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1512900
Study Med. Week No. (specify)
Description

Study Med. Week No.

Data type

integer

Alias
UMLS CUI [1]
C0439230
Medication Label
Description

Medication Label

Data type

text

Alias
UMLS CUI [1]
C0013227
Medication Labels
Description

Medication Labels

Alias
UMLS CUI-1
C0013227
Study Med. Week No. (specify)
Description

Study Med. Week No.

Data type

integer

Alias
UMLS CUI [1]
C0439230
Medication Label
Description

Medication Label

Data type

text

Alias
UMLS CUI [1]
C0013227
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Similar models

Study medication and compliance record

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Study medication
C0013227 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C0035258 (UMLS CUI-4)
Item
Study Med. Week No.
integer
C0439230 (UMLS CUI [1])
Study Medication Week No.
Code List
Study Med. Week No.
CL Item
Wk 1 (Days 1-3) (1)
CL Item
Wk 1 (Days 4-7) (2)
CL Item
Wk 2 (3)
CL Item
Wk 3 (4)
CL Item
Wk 4 (5)
CL Item
Wk 5 (6)
CL Item
Wk 6 (7)
CL Item
Wk 7-8 (8)
CL Item
Wk 9-10 (9)
CL Item
Wk 11-12 (10)
CL Item
Wk ECG (11)
Dose reduction
Item
Is this a Dose Reduction?
boolean
C1707814 (UMLS CUI [1])
Dose level
Item
Dose Level (Specify 1 - 8)
integer
C0178602 (UMLS CUI [1])
Date of first dose
Item
Date of first dose
date
C3173309 (UMLS CUI [1])
Date of 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])
C0039225 (UMLS CUI [1,2])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Interruption
Item
Interruption of ≥ 2 consecutive days?
boolean
C0304229 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Item Group
Dose Reduction due to adverse experiences
C1707814 (UMLS CUI-1)
C0559546 (UMLS CUI-2)
Study Med. Week No.
Item
Study Med. Week No. (Specify)
integer
C0304229 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Dose level
Item
Dose level (specify)
integer
C0178602 (UMLS CUI [1])
Date of first dose
Item
Date of first dose
date
C3173309 (UMLS CUI [1])
Date of 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])
C0039225 (UMLS CUI [1,2])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Interruption
Item
Interruption of 2 consecutive days?
boolean
C0304229 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Study Med. Week No.
Item
Study Med. Week No. (specify)
integer
C0439230 (UMLS CUI [1])
Medication Label
Item
Medication Label
text
C0013227 (UMLS CUI [1])
Item Group
Medication Labels
C0013227 (UMLS CUI-1)
Item
Study Med. Week No. (specify)
integer
C0439230 (UMLS CUI [1])
Study Med. Week No.
Code List
Study Med. Week No. (specify)
CL Item
Week 1 (Days 1 - 3) (1)
CL Item
Week 1 (Days 4 - 7) (2)
CL Item
Week 2 (3)
CL Item
Week 3 (4)
CL Item
Week 4 (5)
CL Item
Week 5 (6)
CL Item
Week 6 (7)
CL Item
Week 7-8 (8)
CL Item
Week 9-10 (9)
CL Item
Week 11-12 (10)
CL Item
ECG Visit (11)
Medication Label
Item
Medication Label
text
C0013227 (UMLS CUI [1])
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