ID

35516

Beschrijving

Study ID: 101468/194 Clinical Study ID: 101468/194 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: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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  1. 06-03-19 06-03-19 -
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GlaxoSmithKline

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6 maart 2019

DOI

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Creative Commons BY-NC 3.0
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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

Engels

Study Medication and Compliance Record

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beschrijving

Study Coordinating Center, Identification number

Datatype

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beschrijving

Person Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Study Medication Record
Beschrijving

Study Medication Record

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C2734539
Study Med. Week No.
Beschrijving

Experimental drug, Week, Numbers

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C0237753
Is this a Dose Reduction?
Beschrijving

if ’No’, continue if ’Yes’, please complete theDose Reductions due to AE on page 64. Do not continue on this page for this visit.

Datatype

boolean

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

Experimental drug, Dosage, Level

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0441889
Date First Dose
Beschrijving

Experimental drug, Medication dose, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C0808070
Date Last Dose
Beschrijving

Experimental drug, Date last dose

Datatype

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
Number of tablets dispensed
Beschrijving

Experimental Drug, Dispensed Amount

Datatype

integer

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

Experimental drug, Returned Amount

Datatype

integer

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

Experimental drug, Interruption

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1512900
Medication Labels
Beschrijving

Experimental Drug, Drug Labeling

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0013191
Dose Reduction Due to Adverse Experiences
Beschrijving

Dose Reduction Due to Adverse Experiences

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1707814
UMLS CUI-3
C0877248
Study Med. Week No.
Beschrijving

Experimental drug, Dose Reduced, Adverse Event, Week, Numbers

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C0439230
UMLS CUI [1,5]
C0237753
Dose Level (Specify 1 - 8)
Beschrijving

Experimental drug, Dose Reduced, Adverse Event, Dosage, Level

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C0441889
Date First Dose
Beschrijving

Experimental drug, Dose Reduced, Adverse Event, Medication dose, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C3174092
UMLS CUI [1,5]
C0808070
Date Last Dose
Beschrijving

Experimental drug, Dose Reduced, Adverse Event, Date last dose

Datatype

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C1762893
Number of tablets dispensed
Beschrijving

Experimental Drug, Dose Reduced, Adverse Event, Dispensed Amount

Datatype

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C0805077
Number of tablets returned
Beschrijving

Experimental drug, Dose Reduced, Adverse Event, Returned Amount

Datatype

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C2699071
Interruption of ≥ 2 consecutive days?
Beschrijving

Experimental drug, Dose Reduced, Adverse Event, Interruption

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C1512900
Medication Labels
Beschrijving

Experimental Drug, Dose Reduced, Adverse Event, Drug Labeling

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C0013191
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Similar models

Study Medication and Compliance Record

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Patient Number
integer
C2348585 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Study Medication Record
C0304229 (UMLS CUI-1)
C2734539 (UMLS CUI-2)
Item
Study Med. Week No.
text
C0304229 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Experimental drug, Week, Numbers
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)
CL Item
Wk 9 (10)
CL Item
Wk 10 (11)
CL Item
Wk 11 (12)
CL Item
Wk 12 (13)
Experimental drug, Dose Reduced
Item
Is this a Dose Reduction?
boolean
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
Experimental drug, Dosage, Level
Item
Dose Level (Specify 1 - 8)
integer
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
Experimental drug, Medication dose, Start Date
Item
Date First Dose
date
C0304229 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Experimental drug, Date last dose
Item
Date Last Dose
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Experimental Drug, Dispensed Amount
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0805077 (UMLS CUI [1,2])
Experimental drug, Returned Amount
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C2699071 (UMLS CUI [1,2])
Experimental drug, Interruption
Item
Interruption of ≥ 2 consecutive days?
boolean
C0304229 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Experimental Drug, Drug Labeling
Item
Medication Labels
text
C0304229 (UMLS CUI [1,1])
C0013191 (UMLS CUI [1,2])
Item Group
Dose Reduction Due to Adverse Experiences
C0304229 (UMLS CUI-1)
C1707814 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Experimental drug, Dose Reduced, Adverse Event, Week, Numbers
Item
Study Med. Week No.
text
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0439230 (UMLS CUI [1,4])
C0237753 (UMLS CUI [1,5])
Experimental drug, Dose Reduced, Adverse Event, Dosage, Level
Item
Dose Level (Specify 1 - 8)
integer
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C0441889 (UMLS CUI [1,5])
Experimental drug, Dose Reduced, Adverse Event, Medication dose, Start Date
Item
Date First Dose
date
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,5])
Experimental drug, Dose Reduced, Adverse Event, Date last dose
Item
Date Last Dose
date
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,4])
Experimental Drug, Dose Reduced, Adverse Event, Dispensed Amount
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0805077 (UMLS CUI [1,4])
Experimental drug, Dose Reduced, Adverse Event, Returned Amount
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2699071 (UMLS CUI [1,4])
Experimental drug, Dose Reduced, Adverse Event, Interruption
Item
Interruption of ≥ 2 consecutive days?
boolean
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C1512900 (UMLS CUI [1,4])
Experimental Drug, Dose Reduced, Adverse Event, Drug Labeling
Item
Medication Labels
text
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0013191 (UMLS CUI [1,4])
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