12-Lead ECG
ECG1-10; Planned relative time is Predose 1, 2, 3 and 2 hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr
datetime
ECG1-10; Planned relative time is Predose 1, 2, 3 and 2 hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr
integer
Ventricular Rate
float
PR Interval
float
QRS Duration
float
Uncorrected QT Interval
float
QTc Interval
float
ECG Result
integer
Predose 24 hour Telemetry ECG
Start date and time of ECG
datetime
End date and time ECG
datetime
Result of the ECG
integer
Postdose 24 Hour Telemetry ECG
Start Date and time of ECG
datetime
End Date and time of ECG
datetime
If abnormal - clinically significant: 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 additional Telemetry ECG Abnormalities page if clinically significant abnormalities are present.
integer
10 Hour Telemetry ECG
Start Date and Time of the ECG
datetime
End Date and Time of the ECG
datetime
If abnormal - clinically significant: 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 additional Telemetry ECG Abnormalities page if clinically significant abnormalities are present.
integer