ID

29114

Beskrivning

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)

Nyckelord

Versioner (1)
  1. 2018-02-26 2018-02-26 -
Rättsinnehavare

GlaxoSmithKline (GSK)

Uppladdad den

26 februari 2018

DOI

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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

Engelsk

Study medication and compliance record

1 Formulär  
Administration
Beskrivning

Administration

Alias
UMLS CUI-1
C1320722
Patient number
Beskrivning

Patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Center Number
Beskrivning

Center Number

Datatyp

integer

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

Study medication

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

Study Medication Week No.

Datatyp

integer

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

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

Datatyp

boolean

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

Dose level

Datatyp

integer

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

Date of first dose

Datatyp

date

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

Date of last dose

Datatyp

date

Alias
UMLS CUI [1]
C1762893
Number of tablets dispensed
Beskrivning

Number of tablets dispensed

Datatyp

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Number of tablets returned
Beskrivning

Number of tablets returned

Datatyp

integer

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

Interruption

Datatyp

boolean

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

Dose Reduction due to adverse experiences

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

Study Med. Week No.

Datatyp

integer

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

Dose level

Datatyp

integer

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

Date of first dose

Datatyp

date

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

Date of last dose

Datatyp

date

Alias
UMLS CUI [1]
C1762893
Number of tablets dispensed
Beskrivning

Number of tablets dispensed

Datatyp

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Number of tablets returned
Beskrivning

Number of tablets returned

Datatyp

integer

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

Interruption

Datatyp

boolean

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

Study Med. Week No.

Datatyp

integer

Alias
UMLS CUI [1]
C0439230
Medication Label
Beskrivning

Medication Label

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Medication Labels
Beskrivning

Medication Labels

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

Study Med. Week No.

Datatyp

integer

Alias
UMLS CUI [1]
C0439230
Medication Label
Beskrivning

Medication Label

Datatyp

text

Alias
UMLS CUI [1]
C0013227
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Similar models

Study medication and compliance record

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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