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Part 2: Repeat Dose Phase - Day 23 - 12-LEAD ECG

1 forms  
Administrative data
Description

Administrative data

Subject Identifier
Description

Subject Identifier

Data type

integer

Visit Date
Description

Visit Date

Data type

date

12-lead ECG
Description

12-lead ECG

Start Date of ECG
Description

Start Date of ECG

Data type

date

Planned Relative Time
Description

Planned Relative Time

Data type

time

Start Time of ECG
Description

Start Time of ECG

Data type

time

Ventricular Rate
Description

Ventricular Rate

Data type

integer

Measurement units
  • bpm
bpm
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • msec
msec
QRS Interval
Description

QRS Interval

Data type

integer

Measurement units
  • msec
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • msec
msec
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • msec
msec
Result of the ECG
Description

Enter code for result from the following list

Data type

integer

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 the additional ECG Abnormalities page if clinically significant abnormalities are present
Description

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 the additional ECG Abnormalities page if clinically significant abnormalities are present.

Data type

text

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Similar models

Part 2: Repeat Dose Phase - Day 23 - 12-LEAD ECG

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Item Group
12-lead ECG
Start Date of ECG
Item
Start Date of ECG
date
Planned Relative Time
Item
Planned Relative Time
time
Start Time of ECG
Item
Start Time of ECG
time
Ventricular Rate
Item
Ventricular Rate
integer
PR Interval
Item
PR Interval
integer
QRS Interval
Item
QRS Interval
integer
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
QTc Interval
Item
QTc Interval
integer
Item
Result of the ECG
integer
Result of the ECG
Code List
Result of the 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)
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 the additional ECG Abnormalities page if clinically significant abnormalities are present.
Item
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 the additional ECG Abnormalities page if clinically significant abnormalities are present
text
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