ID

29114

Descripción

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)

Palabras clave

Versiones (1)
  1. 26/2/18 26/2/18 -
Titular de derechos de autor

GlaxoSmithKline (GSK)

Subido en

26 de febrero de 2018

DOI

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Licencia

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

Inglés

Study medication and compliance record

1 formularios  
Administration
Descripción

Administration

Alias
UMLS CUI-1
C1320722
Patient number
Descripción

Patient number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830427
Center Number
Descripción

Center Number

Tipo de datos

integer

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

Study medication

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

Study Medication Week No.

Tipo de datos

integer

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

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

Tipo de datos

boolean

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

Dose level

Tipo de datos

integer

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

Date of first dose

Tipo de datos

date

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

Date of last dose

Tipo de datos

date

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

Number of tablets dispensed

Tipo de datos

integer

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

Number of tablets returned

Tipo de datos

integer

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

Interruption

Tipo de datos

boolean

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

Dose Reduction due to adverse experiences

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

Study Med. Week No.

Tipo de datos

integer

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

Dose level

Tipo de datos

integer

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

Date of first dose

Tipo de datos

date

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

Date of last dose

Tipo de datos

date

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

Number of tablets dispensed

Tipo de datos

integer

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

Number of tablets returned

Tipo de datos

integer

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

Interruption

Tipo de datos

boolean

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

Study Med. Week No.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439230
Medication Label
Descripción

Medication Label

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
Medication Labels
Descripción

Medication Labels

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

Study Med. Week No.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439230
Medication Label
Descripción

Medication Label

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
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Similar models

Study medication and compliance record

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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