Inglés

Part 2: Repeat Dose Phase - Day 25 - 12-LEAD ECG

1 formularios  
Administrative data
Descripción

Administrative data

Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Visit Date
Descripción

Visit Date

Tipo de datos

date

12-lead ECG
Descripción

12-lead ECG

Start Date of ECG
Descripción

Start Date of ECG

Tipo de datos

date

Planned Relative Time
Descripción

pre-dose

Tipo de datos

time

Start Time of ECG
Descripción

Start Time of ECG

Tipo de datos

time

Ventricular Rate
Descripción

Ventricular Rate

Tipo de datos

integer

Unidades de medida
  • bpm
bpm
PR Interval
Descripción

PR Interval

Tipo de datos

integer

Unidades de medida
  • msec
msec
QRS Duration
Descripción

QRS Duration

Tipo de datos

integer

Unidades de medida
  • msec
msec
Uncorrected QT Interval
Descripción

Uncorrected QT Interval

Tipo de datos

integer

Unidades de medida
  • msec
msec
QTc Interval
Descripción

QTc Interval

Tipo de datos

integer

Unidades de medida
  • msec
msec
Result of the ECG
Descripción

enter code for result from the following list

Tipo de datos

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.
Descripción

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 de datos

text

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Similar models

Part 2: Repeat Dose Phase - Day 25 - 12-LEAD ECG

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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 Duration
Item
QRS Duration
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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