ID

25724

Beschrijving

Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen 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 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome Concomitant Medication Section (Treatment Phase and Follow-Up)

Trefwoorden

Versies (1)
  1. 12-09-17 12-09-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 september 2017

DOI

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Licentie

Creative Commons BY-NC-ND 3.0
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Concomitant Medication Section GSK Ropinirole Restless Legs Syndrome 101468

Engels

Concomitant Medication Section GSK Ropinirole Restless Legs Syndrome 101468

1 Formulieren  
Patient Information
Beschrijving

Patient Information

Alias
UMLS CUI-1
C1955348
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Beschrijving

Centre Number

Datatype

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Day
Beschrijving

Visit Day

Datatype

date

Maateenheden
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2827038
dd-mmm-yyyy
Concomitant Medication - If Medical History section is included indications on Prior Medication page must correlate utilizing the same terminlogy. Indication on concomitant page must be recorded on the Adverse Events Page and expressed utilizing the same terminology. If a medication was marked continuing at the initial visit (On the Prior and Concomitant Medication Page), but has since had a dosage change or has been stopped, it must be recorded on this form as a change with the start and end date.
Beschrijving

Concomitant Medication - If Medical History section is included indications on Prior Medication page must correlate utilizing the same terminlogy. Indication on concomitant page must be recorded on the Adverse Events Page and expressed utilizing the same terminology. If a medication was marked continuing at the initial visit (On the Prior and Concomitant Medication Page), but has since had a dosage change or has been stopped, it must be recorded on this form as a change with the start and end date.

Alias
UMLS CUI-1
C2347852
Are there any concomitant medication CHANGES since the start of the study?
Beschrijving

If "YES", please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Events Form, utilizing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0443172
Drug Name (Trade Name Preferred)
Beschrijving

Drug Name

Datatype

text

Alias
UMLS CUI [1]
C0013227
SINGLE Dose/Unit (e.g. 500mg)
Beschrijving

Dose

Datatype

text

Alias
UMLS CUI [1]
C3174092
Frequency of this Dose (e.g. BID, PRN)
Beschrijving

Dose Frequency

Datatype

text

Alias
UMLS CUI [1]
C2826654
Route
Beschrijving

Administration Route

Datatype

text

Indication
Beschrijving

Indication

Datatype

text

Alias
UMLS CUI [1]
C3146298
Start Date
Beschrijving

Start Date - As a minimum the year must be started.

Datatype

date

Maateenheden
  • dd-mmm-yyyy
dd-mmm-yyyy
Start Time
Beschrijving

Start Time

Datatype

time

Maateenheden
  • 24hr:min
Alias
UMLS CUI [1]
C1301880
24hr:min
End Date
Beschrijving

End Date

Datatype

date

Maateenheden
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C0806020
dd-mmm-yyyy
End Time
Beschrijving

End Time

Datatype

time

Maateenheden
  • 24hr:min
Alias
UMLS CUI [1]
C1522314
24hr:min
Continuiing at end of Study?
Beschrijving

Ongoing

Datatype

boolean

Alias
UMLS CUI [1]
C0549178
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Similar models

Concomitant Medication Section GSK Ropinirole Restless Legs Syndrome 101468

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Day
Item
Visit Day
date
C2827038 (UMLS CUI [1])
Item Group
Concomitant Medication - If Medical History section is included indications on Prior Medication page must correlate utilizing the same terminlogy. Indication on concomitant page must be recorded on the Adverse Events Page and expressed utilizing the same terminology. If a medication was marked continuing at the initial visit (On the Prior and Concomitant Medication Page), but has since had a dosage change or has been stopped, it must be recorded on this form as a change with the start and end date.
C2347852 (UMLS CUI-1)
Change of Concomitant Medication
Item
Are there any concomitant medication CHANGES since the start of the study?
boolean
C2347852 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Drug Name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1])
Dose
Item
SINGLE Dose/Unit (e.g. 500mg)
text
C3174092 (UMLS CUI [1])
Dose Frequency
Item
Frequency of this Dose (e.g. BID, PRN)
text
C2826654 (UMLS CUI [1])
Item
Route
text
Administration Route
Code List
Route
CL Item
intra-articular (IA)
CL Item
intra-arterial (IAR)
CL Item
intra-dermal (ID)
CL Item
inhalation (IH)
CL Item
intra-muscular (IM)
CL Item
intra-thecal (IT)
CL Item
intra-venous (IV)
CL Item
nasal (NA)
CL Item
oral (PO)
CL Item
rectal (PR)
CL Item
subcutaneous (SC)
CL Item
sublingual (SL)
CL Item
transdermal (TD)
CL Item
topical (TO)
CL Item
vaginal (VA)
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
End Time
Item
End Time
time
C1522314 (UMLS CUI [1])
Ongoing
Item
Continuiing at end of Study?
boolean
C0549178 (UMLS CUI [1])
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