Table 5.
Hematologic adverse reactions
|
Zytux™ group
(n=122) |
MabThera
®
group
(n=115) |
Total | p -value | ||
|---|---|---|---|---|---|
| Thrombocytopenia | No. (%) | No. (%) | No. (%) | ||
| Grade I (<LLN* to 75,000/mm3) | 13 (11) | 17 (15) | 30 (13) | ||
| Grade II (50,000 to 75,000/mm3) | 9 (7) | 7 (6) | 16 (7) | ||
| Grade III (25,000 to 50,000/mm3) | 4 (3) | 1 (1) | 5 (2) | ||
| Grade IV (<25,000/mm3) | 3 (2) | 0 (0) | 3 (1) | ||
| Total | 29 (24) | 25 (22) | 54 (23) | 0.18 | |
| Anemia (Hemoglobin level) | |||||
| Grade I (<LLN* to 10 g/dL) | 18 (15) | 18 (16) | 36 (15) | ||
| Grade II (8.0 to 10.0 g/dL) | 18 (15) | 16 (14) | 34 (14) | ||
| Grade III (<8.0 g/dL) | 5 (4) | 4 (4) | 9 (4) | ||
| Total | 41 (34) | 38 (33) | 79 (33) | 0.95 | |
| Neutropenia | |||||
| Grade I (<LLN* to 1500/mm3) | 11 (9) | 13 (11) | 24 (10) | ||
| Grade II (1000 to 1500/mm3) | 17 (14) | 16 (14) | 33 (14) | ||
| Grade III (500 to 1000/mm3) | 4 (3) | 6 (5) | 10 (4) | ||
| Grade IV (<500/mm3) | 1 (1) | 1 (1) | 2 (1) | ||
| Total | 33 (27) | 36 (31) | 69 (30) | 0.92 | |
*
LLN: Lower Limit of Normal