ID

27263

Description

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of 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: Requip Study Indication: Parkinson Disease Module: Study Medication and Compliance Record

Keywords

Versions (1)
  1. 11/6/17 11/6/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2017

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License

Creative Commons BY-NC 3.0
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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188

English

Study Medication and Compliance Record

1 forms  
Study Medication And Compliance Record
Description

Study Medication And Compliance Record

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0304229
UMLS CUI-3
C0008972
UMLS CUI-4
C1321605
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Number
Description

Patient Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Study Med. Week No.
Description

Week

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0439230
Is this a Dose Reduction?
Description

if ’No’, continue if ’Yes’, please complete the Dose Reductions due to AE on page 75. Do not continue on this page for this visit.

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707814
Dose Level (Specify 1 - 8)
Description

Dose Level

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
Date First Dose
Description

First Dose Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Last Dose Date
Description

Last Dose Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
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
Interruption of ≥ 2 consecutive days?
Description

medication interruption

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1512900
Attach Medication Labels Below
Description

medication labels

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0181496
Dose Reductions due to Adverse Experiences
Description

Dose Reductions due to Adverse Experiences

Alias
UMLS CUI-1
C1707814
UMLS CUI-2
C0304229
UMLS CUI-3
C1519255
Week (Specify)
Description

Week

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0439230
Dose Level (Specify 1 - 8)
Description

Dose Level

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
Date First Dose
Description

First Dose Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Last Dose Date
Description

Last Dose Date

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
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
Interruption of ≥ 2 consecutive days?
Description

medication interruption

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1512900
Attach Medication Labels Below
Description

medication labels

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0181496
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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
Study Medication And Compliance Record
C2734539 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
C1321605 (UMLS CUI-4)
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item
Study Med. Week No.
integer
C0304229 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Week
Code List
Study Med. Week No.
CL Item
Wk 1 (days 1-2) (1)
CL Item
Wk 1 (days 3-7) (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)
CL Item
Wk 8 (9)
Dose Reduction
Item
Is this a Dose Reduction?
boolean
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
Dose Level
Item
Dose Level (Specify 1 - 8)
integer
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
First Dose Date
Item
Date First Dose
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Last Dose Date
Item
Last Dose Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
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])
medication interruption
Item
Interruption of ≥ 2 consecutive days?
boolean
C0304229 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
medication labels
Item
Attach Medication Labels Below
text
C0304229 (UMLS CUI [1,1])
C0181496 (UMLS CUI [1,2])
Item Group
Dose Reductions due to Adverse Experiences
C1707814 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
Week
Item
Week (Specify)
integer
C0304229 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Dose Level
Item
Dose Level (Specify 1 - 8)
integer
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
First Dose Date
Item
Date First Dose
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Last Dose Date
Item
Last Dose Date
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
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])
medication interruption
Item
Interruption of ≥ 2 consecutive days?
boolean
C0304229 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
medication labels
Item
Attach Medication Labels Below
text
C0304229 (UMLS CUI [1,1])
C0181496 (UMLS CUI [1,2])
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