12-Lead Electrocardiogram
The field Row number is not to be filled in for "mean".
integer
Date
date
Time relative to dosing. The row numbers denote the time values under "planned relative time". Session 1: Three measurements for screening (at least 5 minutes apart). Session 2, day 1: 3 measurements (at least 5 minutes apart) at pre-dose. The mean value recorded pre-dose will be classed as baseline. Then measurements at 20mins, 40mins, 1hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs. Session 2, day 3,5,8,10,12: One measurement for "pre-dose", remaining measurements as at day 1. Session 2, day 7: One measurement at "pre-dose". Session 2, day 14: one measurement at 24hrs. Session 3: One measurement for Follow-up. Measurements at 24hrs are performed immediately prior to dosing on the following day. Planned relative time "unscheduled" can be filled in at each session and each day if neccessary.
text
Actual time
time
ECG measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
integer
ECG measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
integer
ECG measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
integer
ECG measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
integer
ECG measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
integer
ECG normal or abnormal
text
If abnormalities are present which are clinically significant, complete additional ECG ABNORMALITIES FORM. Copy the session number from the top of this form and the date and time to the ECG ABNORMALITIES FORM.
text