12-lead ECG
For screening: ECG1-3 are mandatory for screening. ECG4-6 are possible as unscheduled. For study visit: ECG1-8 are paired at certain points in time, from ECG1 for pre-dose ECG to ECG8 at 24 h post-dose (See Item "planned relative Time", Codelist 3-10). ECG1-6 are possible as unscheduled. For Follow-up: ECG 1 is mandatory. ECG2 and 3 are possible as unscheduled.
integer
day month year
date
3-10: It is only for study visit. 1, 2 and 11 as indicated.
integer
00:00-23:59
time
Heart Rate
integer
PR Interval
float
QRS Duration
float
Uncorrected QT Interval
float
QTc Interval
float
Complete the additional ECG Abnormalities page if clinically significant abnormalities are present. Additional for study visit and follow up: 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.
integer