Table A1.
Disposition | Patients by Dose Level (mg/kg IV) |
|||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
0.3 |
1.0 |
2.0 |
3.0 |
4.0 |
5.0 |
7.0 |
Total |
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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.