ID

25784

Beschreibung

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

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  1. 19.09.17 19.09.17 -
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GlaxoSmithKline

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19. September 2017

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screening prior and concomitant medication Ropinirole CR Ropinirole IR Monotherapy 101468/168

Englisch

screening prior and concomitant medication Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
PRIOR PARKINSON’S MEDICATION
Beschreibung

PRIOR PARKINSON’S MEDICATION

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C0030567
Has the subject taken any prior Parkinson’s medication within 30 days prior to the study?
Beschreibung

If Yes, record below.

Datentyp

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0030567
PRIOR PARKINSON’S MEDICATION
Beschreibung

PRIOR PARKINSON’S MEDICATION

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C0030567
Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Beschreibung

total daily dose

Datentyp

integer

Alias
UMLS CUI [1]
C2348070
Units
Beschreibung

TAB = Tablet MCL = Microlitre ML = Millilitre L = Litre MCG = Microgram MG = Milligram G = Gram

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Route
Beschreibung

IM = Intramuscular IH = Inhalation IV = Intravenous NS = Nasal TP = Topical PO = Oral VG = Vaginal

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Beschreibung

indication

Datentyp

text

Alias
UMLS CUI [1]
C3146298
Start Date
Beschreibung

start date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

stop date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beschreibung

medication ongoing

Datentyp

text

Alias
UMLS CUI [1]
C2826666
PRIOR OR CONCOMITANT MEDICATIONS
Beschreibung

PRIOR OR CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2826257
UMLS CUI-3
C2347852
Were any concomitant medications taken by the subject within 30 days prior to the study (excluding parkinson’s medications)?
Beschreibung

If Yes, record below.

Datentyp

text

Alias
UMLS CUI [1]
C2347852
PRIOR OR CONCOMITANT MEDICATIONS
Beschreibung

PRIOR OR CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Drug Name
Beschreibung

Trade Name preferred

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Beschreibung

total daily dose

Datentyp

integer

Alias
UMLS CUI [1]
C2348070
Units
Beschreibung

TAB = Tablet MCL = Microlitre ML = Millilitre L = Litre MCG = Microgram MG = Milligram G = Gram

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Route
Beschreibung

IM = Intramuscular IH = Inhalation IV = Intravenous NS = Nasal TP = Topical PO = Oral VG = Vaginal

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Beschreibung

indication

Datentyp

text

Alias
UMLS CUI [1]
C3146298
Start Date
Beschreibung

start date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschreibung

stop date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beschreibung

medication ongoing

Datentyp

text

Alias
UMLS CUI [1]
C2826666
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Ähnliche Modelle

screening prior and concomitant medication Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
PRIOR PARKINSON’S MEDICATION
C2826257 (UMLS CUI-1)
C0030567 (UMLS CUI-2)
Item
Has the subject taken any prior Parkinson’s medication within 30 days prior to the study?
text
C2826257 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
prior medication due to Parkinson's disease
Code List
Has the subject taken any prior Parkinson’s medication within 30 days prior to the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
PRIOR PARKINSON’S MEDICATION
C2826257 (UMLS CUI-1)
C0030567 (UMLS CUI-2)
medication name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
total daily dose
Item
Total Daily Dose
integer
C2348070 (UMLS CUI [1])
units
Item
Units
text
C1519795 (UMLS CUI [1])
route
Item
Route
text
C0013153 (UMLS CUI [1])
indication
Item
Reason for Medication
text
C3146298 (UMLS CUI [1])
start date
Item
Start Date
date
C0808070 (UMLS CUI [1])
stop date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
medication ongoing
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
PRIOR OR CONCOMITANT MEDICATIONS
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
Item
Were any concomitant medications taken by the subject within 30 days prior to the study (excluding parkinson’s medications)?
text
C2347852 (UMLS CUI [1])
concomitant medication
Code List
Were any concomitant medications taken by the subject within 30 days prior to the study (excluding parkinson’s medications)?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
PRIOR OR CONCOMITANT MEDICATIONS
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
medication name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
total daily dose
Item
Total Daily Dose
integer
C2348070 (UMLS CUI [1])
units
Item
Units
text
C1519795 (UMLS CUI [1])
route
Item
Route
text
C0013153 (UMLS CUI [1])
indication
Item
Reason for Medication
text
C3146298 (UMLS CUI [1])
start date
Item
Start Date
date
C0808070 (UMLS CUI [1])
stop date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
medication ongoing
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
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