39 3.3.1 Adverse Events ................................................................................................. 40 3.3.2 Laboratory data ................................................................................................. 42 3.3.3 ECG data .......................................................................................................... 43 3.3.4 Vital signs ......................................................................................................... 43 3.3.5 Exposure and dose intensit y.............................................................................. 43 3.3.6 Dose Limit ing Toxi cities (DLTs) ...................................................................... 44 Statistical A nal ysis Pla n St u d y C o de D 4 1 9 E C 0 0 0 0 1 E diti o n N u m ber 4.