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. 2009 Nov 30;28(2):207–214. doi: 10.1200/JCO.2009.22.9237

Table A1.

Patient Disposition

Disposition Patients by Dose Level (mg/kg IV)
0.3
1.0
2.0
3.0
4.0
5.0
7.0
Total
No. % No. % No. % No. % No. % No. % No. % No. %
Patients enrolled with informed consent 59 100
Patients treated 3 100 8 100 6 100 7 100 7 100 4 100 12 100 47 79.7
Reason for study discontinuation
    Adverse event 0 1 12.5 1 16.7 2 28.6 4 57.1 2 50.0 3 25.0 13 27.7
    Progressive disease 3 100 6 75.0 4 66.7 5 71.4 3 42.9 2 50.0 6 50.0 29 61.7
    Patient did not wish to continue 0 0 1 16.7 0 0 0 1 8.3 2 4.3
    No longer required study treatment 0 0 0 0 0 0 0 0
    Protocol violation 0 0 0 0 0 0 0 0
    Lost to follow-up 0 0 0 0 0 0 0 0
    Death 0 0 0 0 0 0 0 0
    Ongoing 0 1 12.5 0 0 0 0 0 1 2.1
    Other 0 0 0 0 0 0 1 8.3 1 2.1

NOTE. For those patients receiving different study treatment doses between the dose-escalation phase and the long-term safety phase of the study, the assigned dose in long-term treatment phase is reported in the table.

Abbreviation: IV, intravenous.