Englisch

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

1 Formulare  
Administrative data
Beschreibung

Administrative data

Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Visit Date
Beschreibung

Visit Date

Datentyp

date

12-lead ECG
Beschreibung

12-lead ECG

Start Date of ECG
Beschreibung

Start Date of ECG

Datentyp

date

Planned Relative Time
Beschreibung

Planned Relative Time

Datentyp

time

Start Time of ECG
Beschreibung

Start Time of ECG

Datentyp

time

Ventricular Rate
Beschreibung

Ventricular Rate

Datentyp

integer

Maßeinheiten
  • bpm
bpm
PR Interval
Beschreibung

PR Interval

Datentyp

integer

Maßeinheiten
  • msec
msec
QRS Interval
Beschreibung

QRS Interval

Datentyp

integer

Maßeinheiten
  • msec
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

integer

Maßeinheiten
  • msec
msec
QTc Interval
Beschreibung

QTc Interval

Datentyp

integer

Maßeinheiten
  • msec
msec
Result of the ECG
Beschreibung

Enter code for result from the following list

Datentyp

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
Beschreibung

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.

Datentyp

text

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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