visit 3 & 4 study drug compliance starting dose of ropinirole Parkinson's Disease 101468/166

1 Formulare

StudyEvent: ODM
1. visit 3 & 4 study drug compliance starting dose of ropinirole Parkinson's Disease 101468/166

Administrative Data

Beschreibung

Administrative Data

Alias

UMLS CUI-1: C1320722

Patient Initials

Beschreibung

patient's initials

Datentyp

text

Alias

UMLS CUI [1]: C2986440

Patient No.

Beschreibung

patient number

Datentyp

integer

Alias

UMLS CUI [1]: C1830427

Number of Visit

Beschreibung

Number of Visit

Alias

UMLS CUI-1: C1549755

Number of Visit

Beschreibung

number of visit

Datentyp

integer

Alias

UMLS CUI [1]: C1549755

Study Period Visit 3 (Day 4) (1)

Study Period VIsit 4 (Day 8) (2)

Return of unused study drugs

Beschreibung

Return of unused study drugs

Alias

UMLS CUI-1: C2699071

Has the patient returned the bottles and any unused study drug?

Beschreibung

study drug return

Datentyp

integer

Alias

UMLS CUI [1]: C2699071

Yes (1)

No (2)

Regimen: prescribed number of tablets per day

Beschreibung

Regimen: prescribed number of tablets per day

Alias

UMLS CUI-1: C3166216

UMLS CUI-2: C0039225

UMLS CUI-3: C0237753

Tablets Bottle 1

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Tablets Bottle 2

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Tablets Bottle 3

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Tablets Bottle 4

Beschreibung

only for patients in Cohort E, all others mark "NA"

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Total number of tablets dispensed at last visit

Beschreibung

Total number of tablets dispensed at last visit

Alias

UMLS CUI-1: C0805077

UMLS CUI-2: C0304229

Tablets Bottle 1

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Tablets Bottle 2

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Tablets Bottle 3

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Tablets Bottle 4

Beschreibung

only for patients in Cohort E, all others mark "NA"

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Total number of tablets returned at this visit

Beschreibung

Total number of tablets returned at this visit

Alias

UMLS CUI-1: C0993159

UMLS CUI-2: C2699071

Tablets Bottle 1

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Tablets Bottle 2

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Tablets Bottle 3

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Tablets Bottle 4

Beschreibung

only for patients in Cohort E, all others mark "NA"

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Number of tablets taken by the patient (according to the diary card)

Beschreibung

Number of tablets taken by the patient (according to the diary card)

Alias

UMLS CUI-1: C1290952

Tablets Bottle 1

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Tablets Bottle 2

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Tablets Bottle 3

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Tablets Bottle 4

Beschreibung

only for patients in Cohort E, all others mark "NA"

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

TOTAL Number of tablets taken - all bottles

Beschreibung

TOTAL Number of tablets taken - all bottles

Alias

UMLS CUI-1: C0039225

UMLS CUI-2: C0237753

UMLS CUI-3: C1883727

Tablets

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

TOTAL Number of tablets patient should have taken ( assuming 100% compliance)

Beschreibung

TOTAL Number of tablets patient should have taken ( assuming 100% compliance)

Alias

UMLS CUI-1: C0039225

UMLS CUI-2: C0237753

UMLS CUI-3: C1883727

Tablets

Beschreibung

number of tablets

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

Patient's Compliance

Beschreibung

Patient's Compliance

Alias

UMLS CUI-1: C1321605

Percent compliance (Total# of tablets taken/ Total# of tablets should have taken)

Beschreibung

If patient is <75% compliant, notify the PAR EXEL Medical Monitor or designee)

Datentyp

integer

Maßeinheiten

Alias

UMLS CUI [1]: C1321605

Tablet Count

Beschreibung

Tablet Count

Alias

UMLS CUI-1: C0039225

UMLS CUI-2: C0237753

Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?

Beschreibung

If "No", explain below.

Datentyp

integer

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

UMLS CUI [1,3]: C0205197

Yes (1)

No (2)

Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?

Beschreibung

If No, please explain

Datentyp

text

Alias

UMLS CUI [1,1]: C0039225

UMLS CUI [1,2]: C0237753

UMLS CUI [1,3]: C0205197

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visit 3 & 4 study drug compliance starting dose of ropinirole Parkinson's Disease 101468/166

1 Formulare

StudyEvent: ODM
1. visit 3 & 4 study drug compliance starting dose of ropinirole Parkinson's Disease 101468/166

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

administrative data

Item Group

Administrative Data

C1320722 (UMLS CUI-1)

patient's initials

Item

Patient Initials

text

C2986440 (UMLS CUI [1])

patient number

Item

Patient No.

integer

C1830427 (UMLS CUI [1])

number of visit

Item Group

Number of Visit

C1549755 (UMLS CUI-1)

number of visit

Item

Number of Visit

integer

C1549755 (UMLS CUI [1])

number of visit

Code List

Number of Visit

CL Item

Study Period Visit 3 (Day 4) (1)

CL Item

Study Period VIsit 4 (Day 8) (2)

return of unused study drugs

Item Group

Return of unused study drugs

C2699071 (UMLS CUI-1)

study drug return

Item

Has the patient returned the bottles and any unused study drug?

integer

C2699071 (UMLS CUI [1])

study drug return

Code List

Has the patient returned the bottles and any unused study drug?

CL Item

Yes (1)

CL Item

No (2)

prescribed medication

Item Group

Regimen: prescribed number of tablets per day

C3166216 (UMLS CUI-1)
C0039225 (UMLS CUI-2)
C0237753 (UMLS CUI-3)

number of tablets

Item

Tablets Bottle 1

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets

Item

Tablets Bottle 2

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets

Item

Tablets Bottle 3

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets

Item

Tablets Bottle 4

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets dispensed

Item Group

Total number of tablets dispensed at last visit

C0805077 (UMLS CUI-1)
C0304229 (UMLS CUI-2)

number of tablets

Item

Tablets Bottle 1

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets

Item

Tablets Bottle 2

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets

Item

Tablets Bottle 3

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets

Item

Tablets Bottle 4

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets returned

Item Group

Total number of tablets returned at this visit

C0993159 (UMLS CUI-1)
C2699071 (UMLS CUI-2)

number of tablets

Item

Tablets Bottle 1

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets

Item

Tablets Bottle 2

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets

Item

Tablets Bottle 3

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets

Item

Tablets Bottle 4

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

medication taken

Item Group

Number of tablets taken by the patient (according to the diary card)

C1290952 (UMLS CUI-1)

number of tablets

Item

Tablets Bottle 1

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets

Item

Tablets Bottle 2

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets

Item

Tablets Bottle 3

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets

Item

Tablets Bottle 4

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets taken

Item Group

TOTAL Number of tablets taken - all bottles

C0039225 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
C1883727 (UMLS CUI-3)

number of tablets

Item

Tablets

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

number of tablets should have been taken

Item Group

TOTAL Number of tablets patient should have taken ( assuming 100% compliance)

C0039225 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
C1883727 (UMLS CUI-3)

number of tablets

Item

Tablets

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

compliance

Item Group

Patient's Compliance

C1321605 (UMLS CUI-1)

compliance

Item

Percent compliance (Total# of tablets taken/ Total# of tablets should have taken)

integer

C1321605 (UMLS CUI [1])

number of tablets

Item Group

Tablet Count

C0039225 (UMLS CUI-1)
C0237753 (UMLS CUI-2)

number of tablets complete

Item

Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?

integer

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])

number of tablets complete

Code List

Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?

CL Item

Yes (1)

CL Item

No (2)

number of tablets complete

Item

Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?

text

C0039225 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])

number of tablets complete

Code List

Is tablet count internally consistent (i.e., # dispensed = # taken +#returned)?

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