screening & final examination electrocardiography PK and tolerability of ropinirole as 5 new formulations 101468/197

1 forms

StudyEvent: ODM
1. screening & final examination electrocardiography PK and tolerability of ropinirole as 5 new formulations 101468/197

Administrative Data

Description

Administrative Data

Alias

UMLS CUI-1: C1320722

Focus Panel ID

Description

focus panel

Data type

integer

Alias

UMLS CUI [1]: C3846158

Patient No

Description

patient number

Data type

integer

Alias

UMLS CUI [1]: C1830427

Date

Description

date

Data type

date

Alias

UMLS CUI [1]: C0011008

Treatment

Description

Only fulfill this item for "final examination".

Data type

text

Alias

UMLS CUI [1]: C0087111

Visit

Description

visit

Data type

text

Alias

UMLS CUI [1]: C0545082

Screening (Screening)

Final examination (Final examination)

12-LEAD ECG

Description

12-LEAD ECG

Alias

UMLS CUI-1: C0430456

Time

Description

time

Data type

time

Alias

UMLS CUI [1]: C0040223

Description

heart rate

Data type

integer

Measurement units

1/min

Alias

UMLS CUI [1]: C0018810

1/min

Description

PR-interval

Data type

integer

Measurement units

msec

Alias

UMLS CUI [1]: C0429087

msec

QRS

Description

QRS duration

Data type

integer

Measurement units

msec

Alias

UMLS CUI [1]: C1880451

msec

Description

QT interval

Data type

integer

Measurement units

msec

Alias

UMLS CUI [1]: C1880452

msec

QTc

Description

QTc interval

Data type

integer

Measurement units

msec

Alias

UMLS CUI [1]: C0489625

msec

Is the ECG normal?

Description

ECG normal

Data type

text

Alias

UMLS CUI [1]: C0522054

Yes (Yes)

No (No)

If abnormal, clinically relevant?

Description

ECG abnormal

Data type

text

Alias

UMLS CUI [1]: C0522055

Yes (Yes)

No (No)

Comments

Description

comment

Data type

text

Alias

UMLS CUI [1]: C0947611

Initials

Description

initials

Data type

text

Alias

UMLS CUI [1]: C2986440

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screening & final examination electrocardiography PK and tolerability of ropinirole as 5 new formulations 101468/197

1 forms

StudyEvent: ODM
1. screening & final examination electrocardiography PK and tolerability of ropinirole as 5 new formulations 101468/197

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

administrative data

Item Group

Administrative Data

C1320722 (UMLS CUI-1)

focus panel

Item

Focus Panel ID

integer

C3846158 (UMLS CUI [1])

patient number

Item

Patient No

integer

C1830427 (UMLS CUI [1])

date

Item

Date

date

C0011008 (UMLS CUI [1])

treatment

Item

Treatment

text

C0087111 (UMLS CUI [1])

visit

Item

Visit

text

C0545082 (UMLS CUI [1])

visit

Code List

Visit

CL Item

Screening (Screening)

CL Item

Final examination (Final examination)

12-lead ECG

Item Group

12-LEAD ECG

C0430456 (UMLS CUI-1)

time

Item

Time

time

C0040223 (UMLS CUI [1])

heart rate

Item

integer

C0018810 (UMLS CUI [1])

PR-interval

Item

integer

C0429087 (UMLS CUI [1])

QRS duration

Item

QRS

integer

C1880451 (UMLS CUI [1])

QT interval

Item

integer

C1880452 (UMLS CUI [1])

QTc interval

Item

QTc

integer

C0489625 (UMLS CUI [1])

ECG normal

Item

Is the ECG normal?

text

C0522054 (UMLS CUI [1])

ECG normal

Code List

Is the ECG normal?

CL Item

Yes (Yes)

CL Item

No (No)

ECG abnormal

Item

If abnormal, clinically relevant?

text

C0522055 (UMLS CUI [1])

ECG abnormal

Code List

If abnormal, clinically relevant?

CL Item

Yes (Yes)

CL Item

No (No)

comment

Item

Comments

text

C0947611 (UMLS CUI [1])

initials

Item

Initials

text

C2986440 (UMLS CUI [1])

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