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12-Lead-ECG (All Part A Visits)

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Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Type of Visit
Beschrijving

Visit

Datatype

text

Alias
UMLS CUI [1]
C0545082
12-Lead ECG
Beschrijving

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Planned relative Time on Session Days 1.
Beschrijving

Not to be filled at Screening, Early Withdrawal or Follow-Up Visit.

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
Start Date of ECG
Beschrijving

Start Date of ECG

Datatype

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Time of ECG
Beschrijving

Start Time of ECG

Datatype

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0430456
beats/min
PR Interval
Beschrijving

PR Interval

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beschrijving

QRS Duration

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
uncorrected QT interval
Beschrijving

uncorrected QT interval

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
UMLS CUI [1,3]
C4072785
msec
QTc interval
Beschrijving

QTc interval

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0855331
msec
Result of ECG
Beschrijving

Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional ECG abnormalities pages if clinically abnormalities are present.

Datatype

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
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Similar models

12-Lead-ECG (All Part A Visits)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item
Type of Visit
text
C0545082 (UMLS CUI [1])
Visit
Code List
Type of Visit
CL Item
Screening (Screening)
(Comment:en)
CL Item
Session 1 (Day 1) (Session 1 (Day 1))
(Comment:en)
CL Item
Early Withdrawal (Early Withdrawal)
(Comment:en)
CL Item
Follow-Up (Follow-Up)
(Comment:en)
CL Item
Session 2 (Day 1) (Session 2 (Day 1))
(Comment:en)
CL Item
Unscheduled (Unscheduled)
(Comment:en)
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
Planned relative Time on Session Days 1.
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned relative Time
Code List
Planned relative Time on Session Days 1.
CL Item
Pre-dose (Pre-dose)
CL Item
1hrs (1hrs)
CL Item
2hrs (2hrs)
CL Item
5hrs (5hrs)
CL Item
6hrs (6hrs)
CL Item
8hrs (8hrs)
CL Item
12hrs (12hrs)
CL Item
24hrs (24hrs)
CL Item
48hrs (48hrs)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
uncorrected QT interval
Item
uncorrected QT interval
float
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,3])
QTc interval
Item
QTc interval
float
C0855331 (UMLS CUI [1])
Item
Result of ECG
integer
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of ECG
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
abnormal - clinically significant (3)
CL Item
no result (not available) (4)
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