ID

26289

Beschrijving

Patient's diary - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 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

Trefwoorden

Versies (1)
  1. 15-10-17 15-10-17 -
Houder van rechten

glaxoSmithKline

Geüploaded op

15 oktober 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Patient's diary - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

Engels

Patient's diary - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulieren  
Patient's daily diary
Beschrijving

Patient's daily diary

Alias
UMLS CUI-1
C0018700
Part
Beschrijving

Clinical trial part

Datatype

integer

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
Treatment period
Beschrijving

Clinical trial treatment period

Datatype

text

Alias
UMLS CUI [1]
C2347804
Patient Initials
Beschrijving

Patient Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Patient No
Beschrijving

patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Start completing this diary on
Beschrijving

Start date health diary

Datatype

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0011008
If you have any question about your study medication between visits call
Beschrijving

Phone number

Datatype

integer

Alias
UMLS CUI [1]
C1515258
Your next clinic visit is
Beschrijving

Next clinic visit

Datatype

datetime

Alias
UMLS CUI [1,1]
C2735342
UMLS CUI [1,2]
C0008952
UMLS CUI [1,3]
C0040223
Health related event
Beschrijving

Health related event

Alias
UMLS CUI-1
C1562065
Event
Beschrijving

Use this section of the diary page to record any unusual health-related event that you have experienced since the last study visit. Please include stop and start dates or tick the "continued" box if the event is still going on.

Datatype

text

Alias
UMLS CUI [1]
C1562065
Date and time
Beschrijving

Date and time event started

Datatype

datetime

Alias
UMLS CUI [1]
C2826806
Date and time stopped
Beschrijving

Date and time stopped event

Datatype

datetime

Alias
UMLS CUI [1]
C2826793
Continued
Beschrijving

Event continuing

Datatype

boolean

Alias
UMLS CUI [1]
C2826663
Study Drug
Beschrijving

Study Drug

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0008972
Date taken
Beschrijving

Date study medication taken

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013227
Time taken
Beschrijving

Time study medication taken

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013227
Dosage
Beschrijving

Dosage study medication

Datatype

float

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0304229
Treatment
Beschrijving

Treatment arm

Datatype

integer

Alias
UMLS CUI [1]
C1522541
Concomitant medication
Beschrijving

Concomitant medication

Alias
UMLS CUI-1
C2347852
Name of drug
Beschrijving

Use this section of the diary page to record any medications or vitamins (other than study drug) that you have taken since the last study visit. Please remember to bring the diary with you when you return to the cllinic for your next visit. Example: Ibuprofen

Datatype

text

Alias
UMLS CUI [1]
C3699427
Total dose
Beschrijving

units/dose e.g. 600mg

Datatype

float

Taken from
Beschrijving

eg. 04 - Sep

Datatype

partialDate

Maateenheden
  • DD-MMM
Alias
UMLS CUI [1]
C2826734
DD-MMM
Taken to
Beschrijving

e.g. 06 - Sep

Datatype

partialDate

Maateenheden
  • DD - MMM
Alias
UMLS CUI [1]
C2826744
DD - MMM
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Similar models

Patient's diary - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Patient's daily diary
C0018700 (UMLS CUI-1)
Clinical trial part
Item
Part
integer
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Clinical trial treatment period
Item
Treatment period
text
C2347804 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No
integer
C1830427 (UMLS CUI [1])
Start date health diary
Item
Start completing this diary on
date
C3890583 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Phone number
Item
If you have any question about your study medication between visits call
integer
C1515258 (UMLS CUI [1])
Next clinic visit
Item
Your next clinic visit is
datetime
C2735342 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Health related event
C1562065 (UMLS CUI-1)
Health related event
Item
Event
text
C1562065 (UMLS CUI [1])
Date and time event started
Item
Date and time
datetime
C2826806 (UMLS CUI [1])
Date and time stopped event
Item
Date and time stopped
datetime
C2826793 (UMLS CUI [1])
Event continuing
Item
Continued
boolean
C2826663 (UMLS CUI [1])
Item Group
Study Drug
C0013227 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date study medication taken
Item
Date taken
date
C0011008 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Time study medication taken
Item
Time taken
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Dosage study medication
Item
Dosage
float
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
Treatment
integer
C1522541 (UMLS CUI [1])
Treatment arm
Code List
Treatment
CL Item
CR (1)
CL Item
IR (2)
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Name of drug generic
Item
Name of drug
text
C3699427 (UMLS CUI [1])
Total dose
Item
Total dose
float
Start date concomitant medication
Item
Taken from
partialDate
C2826734 (UMLS CUI [1])
End date concomitant medication
Item
Taken to
partialDate
C2826744 (UMLS CUI [1])
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