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

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Administrative data
Beschrijving

Administrative data

Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Visit Date
Beschrijving

Visit Date

Datatype

date

12-lead ECG
Beschrijving

12-lead ECG

Start Date of ECG
Beschrijving

Start Date of ECG

Datatype

date

Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

time

Start Time of ECG
Beschrijving

Start Time of ECG

Datatype

time

Ventricular Rate
Beschrijving

Ventricular Rate

Datatype

integer

Maateenheden
  • bpm
bpm
PR Interval
Beschrijving

PR Interval

Datatype

integer

Maateenheden
  • msec
msec
QRS Interval
Beschrijving

QRS Interval

Datatype

integer

Maateenheden
  • msec
msec
Uncorrected QT Interval
Beschrijving

Uncorrected QT Interval

Datatype

integer

Maateenheden
  • msec
msec
QTc Interval
Beschrijving

QTc Interval

Datatype

integer

Maateenheden
  • msec
msec
Result of the ECG
Beschrijving

Enter code for result from the following list

Datatype

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

Datatype

text

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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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