Table 2.
Patient disposition
| PX-171 | 003-A0 n=46 |
003-A1 n=266 |
004 n=164 |
005 n=50 |
ISA n=526 |
|---|---|---|---|---|---|
| Median cycles (n) | 3 | 4 | 6 | 4 | 4 |
| Dose reduced due to AE, n (%) | 3 (6.5) | 47 (17.7) | 18 (11.0) | 9 (18.0) | 77 (14.6) |
| ≥12 cycles or on therapy,* n (%) | 4 (8.7) | 40 (15.0) | 55 (33.5) | 16 (32.0) | 115 (21.9) |
| <12 cycles, n (%) | 42 (91.3) | 226 (85.0) | 109 (66.5) | 34 (68.0) | 411 (78.1) |
| Progressive disease | 23 (50.0) | 157 (59.0) | 64 (39.0) | 24 (48.0) | 268 (51.0) |
| AE | 13 (28.3) | 33 (12.4) | 26 (15.9) | 6 (12.0) | 78 (14.8) |
| Withdrew consent | 2 (4.3) | 22 (8.3) | 9 (5.5) | 4 (8.0) | 37 (7.0) |
| Other | 4 (8.7) | 14 (5.3) | 10 (6.1) | 0 (0) | 28 (5.3) |
Notes:
*
At data cutoff. Obtained from Haematologica/the Hematology Journal website http://www.haematologica.org.12
Abbreviations: AE, adverse event; ISA, integrated safety analysis.