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

1 moduli  
Administrative data
Descrizione

Administrative data

Subject Identifier
Descrizione

Subject Identifier

Tipo di dati

integer

Visit Date
Descrizione

Visit Date

Tipo di dati

date

12-lead ECG
Descrizione

12-lead ECG

Start Date of ECG
Descrizione

Start Date of ECG

Tipo di dati

date

Planned Relative Time
Descrizione

Planned Relative Time

Tipo di dati

time

Start Time of ECG
Descrizione

Start Time of ECG

Tipo di dati

time

Ventricular Rate
Descrizione

Ventricular Rate

Tipo di dati

integer

Unità di misura
  • bpm
bpm
PR Interval
Descrizione

PR Interval

Tipo di dati

integer

Unità di misura
  • msec
msec
QRS Interval
Descrizione

QRS Interval

Tipo di dati

integer

Unità di misura
  • msec
msec
Uncorrected QT Interval
Descrizione

Uncorrected QT Interval

Tipo di dati

integer

Unità di misura
  • msec
msec
QTc Interval
Descrizione

QTc Interval

Tipo di dati

integer

Unità di misura
  • msec
msec
Result of the ECG
Descrizione

Enter code for result from the following list

Tipo di dati

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
Descrizione

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.

Tipo di dati

text

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Similar models

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

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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