ID

26221

Beschreibung

Study ID: 101468/190 Clinical Study ID: SKF-101468/190 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 This is the study medication and compliance form.

Stichworte

Versionen (1)
  1. 12.10.17 12.10.17 -
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GlaxoSmithKline

Hochgeladen am

12. Oktober 2017

DOI

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26072_GSK Ropinirole in Patients Suffering from Restless Legs Syndrome study medication and compliance 101468/190

Englisch

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome study medication and compliance 101468/190

1 Formulare  
General Information
Beschreibung

General Information

Alias
UMLS CUI-1
C1508263
Centre Number
Beschreibung

Centre Number

Datentyp

text

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

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Study Medication
Beschreibung

Study Medication

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0008976
UMLS CUI-3
C0035258
Is this a Dose Reduction?
Beschreibung

Dose Reduction

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C1707814
Dose Level
Beschreibung

(Specify 1 - 8)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0178602
First Dose
Beschreibung

First Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C0035258
Last Dose
Beschreibung

Last Dose

Datentyp

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0035258
Number of tablets dispensed
Beschreibung

Number of tablets dispensed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0035258
Number of tablets returned
Beschreibung

Number of tablets returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0035258
Interruption of more than 2 consecutive days?
Beschreibung

Interruption of more than 2 consecutive days?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0035258
UMLS CUI [1,4]
C0680259
Medication Labels
Beschreibung

Medication Labels

Alias
UMLS CUI-1
C3262382
UMLS CUI-2
C0304229
UMLS CUI-3
C0035258
Medikation Label
Beschreibung

Medication Label

Datentyp

text

Alias
UMLS CUI [1,1]
C3262382
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0035258
DOSE REDUCTIONS DUE TO ADVERSE EXPERIENCES
Beschreibung

DOSE REDUCTIONS DUE TO ADVERSE EXPERIENCES

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0035258
UMLS CUI-3
C1707814
UMLS CUI-4
C0559546
Week
Beschreibung

Specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0439230
UMLS CUI [1,4]
C1707814
UMLS CUI [1,5]
C0559546
Dose Level
Beschreibung

Specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C1707814
UMLS CUI [1,5]
C0559546
Date First Dose
Beschreibung

First Dose Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0035258
UMLS CUI [1,4]
C3173309
Date of last dose
Beschreibung

Date last dose

Datentyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0035258
UMLS CUI [1,3]
C1762893
Number of tablets dispensed
Beschreibung

Number of tablets dispensed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0035258
Number of tablets returned
Beschreibung

Number of tablets returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0035258
Interruption of more than 2 consecutive days?
Beschreibung

Interruption

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512900
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0035258
MEDICATION LABELS
Beschreibung

MEDICATION LABELS

Alias
UMLS CUI-1
C3262382
UMLS CUI-2
C0304229
UMLS CUI-3
C0035258
Medication Labels
Beschreibung

Medication Labels

Datentyp

text

Alias
UMLS CUI [1,1]
C3262382
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0035258
Withdrawal
Beschreibung

Withdrawal

Alias
UMLS CUI-1
C0422727
IF MORE THAN 2 DOSE REDUCTIONS ARE REQUIRED THE PATIENT SHOULD BE WITHDRAWN AND THE EARLY WITHDRAWAL SECTION COMPLETED
Beschreibung

Withdrawal

Datentyp

boolean

Alias
UMLS CUI [1]
C0422727
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Ähnliche Modelle

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome study medication and compliance 101468/190

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Study Medication
C0304229 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0035258 (UMLS CUI-3)
Item
Is this a Dose Reduction?
integer
C0304229 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
Dose Reduction
Code List
Is this a Dose Reduction?
CL Item
No - if ’No’, continue (1)
CL Item
Yes - if ’Yes’, please complete the Dose Reductions due to AE. Do not continue on this page for this visit. (2)
Dose Level
Item
Dose Level
integer
C0304229 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
First Dose
Item
First Dose
date
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0035258 (UMLS CUI [1,5])
Last Dose
Item
Last Dose
date
C1762893 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Number of tablets dispensed
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Interruption of more than 2 consecutive days?
Item
Interruption of more than 2 consecutive days?
boolean
C0304229 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0680259 (UMLS CUI [1,4])
Item Group
Medication Labels
C3262382 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0035258 (UMLS CUI-3)
Medication Label
Item
Medikation Label
text
C3262382 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Item Group
DOSE REDUCTIONS DUE TO ADVERSE EXPERIENCES
C0304229 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
C1707814 (UMLS CUI-3)
C0559546 (UMLS CUI-4)
Week
Item
Week
integer
C0304229 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,3])
C1707814 (UMLS CUI [1,4])
C0559546 (UMLS CUI [1,5])
Dose Level
Item
Dose Level
integer
C0304229 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1707814 (UMLS CUI [1,4])
C0559546 (UMLS CUI [1,5])
First Dose Date
Item
Date First Dose
date
C0013227 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C3173309 (UMLS CUI [1,4])
Date last dose
Item
Date of last dose
date
C0304229 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
Number of tablets dispensed
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Interruption
Item
Interruption of more than 2 consecutive days?
boolean
C1512900 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Item Group
MEDICATION LABELS
C3262382 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0035258 (UMLS CUI-3)
Medication Labels
Item
Medication Labels
text
C3262382 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Item Group
Withdrawal
C0422727 (UMLS CUI-1)
Withdrawal
Item
IF MORE THAN 2 DOSE REDUCTIONS ARE REQUIRED THE PATIENT SHOULD BE WITHDRAWN AND THE EARLY WITHDRAWAL SECTION COMPLETED
boolean
C0422727 (UMLS CUI [1])
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