Table 3.
Acute Adverse Events.*
| Event | All Patients (N = 315) | Chemotherapy Group (N = 153) | Rituximab–Chemotherapy Group (N = 162) | P Value |
|---|---|---|---|---|
| no. of patients (%) | ||||
| During all therapy | ||||
| ≥1 Adverse event | 306 (97.1) | 148 (96.7) | 158 (97.5) | |
| ≥1 Adverse event of grade ≥4 | 111 (35.2) | 50 (32.7) | 61 (37.7) | 0.36 |
| During COP prephase treatment | ||||
| ≥1 Adverse event | 63 (20.0) | 31 (20.3) | 32 (19.8) | |
| ≥1 Adverse event of grade ≥4 | 27 (8.6) | 17 (11.1) | 10 (6.2) | 0.12 |
| After COP prephase treatment | ||||
| ≥1 Adverse event | 303 (96.2) | 147 (96.1) | 156 (96.3) | |
| ≥1 Adverse event of grade ≥4 | 91 (28.9) | 37 (24.2) | 54 (33.3) | 0.07 |
| Most frequent adverse events after COP prephase treatment | ||||
| Febrile neutropenia | 289 (91.7) | 139 (90.8) | 150 (92.6) | |
| Grade 3 | 260 (82.5) | 129 (84.3) | 131 (80.9) | |
| Grade ≥4 | 29 (9.2) | 10 (6.5) | 19 (11.7) | 0.11 |
| Stomatitis | 244 (77.5) | 115 (75.2) | 129 (79.6) | |
| Grade 3 | 224 (71.1) | 108 (70.6) | 116 (71.6) | |
| Grade ≥4 | 20 (6.3) | 7 (4.6) | 13 (8.0) | 0.21 |
| Enteritis | 63 (20.0) | 24 (15.7) | 39 (24.1) | |
| Grade 3 | 62 (19.7) | 24 (15.7) | 38 (23.5) | |
| Grade ≥4 | 1 (0.3) | 0 | 1 (0.6) | 1.00 |
| Infection | 170 (54.0) | 75 (49.0) | 95 (58.6) | |
| Grade 3 | 123 (39.0) | 58 (37.9) | 65 (40.1) | |
| Grade ≥4 | 47 (14.9) | 17 (11.1) | 30 (18.5) | 0.07 |
| Main types of infection | ||||
| Sepsis | 45 (14.3) | 17 (11.1) | 28 (17.3) | |
| Central venous catheter–related infection | 38 (12.1) | 17 (11.1) | 21 (13.0) | |
| Lung infection | 32 (10.2) | 13 (8.5) | 19 (11.7) | |
| Enterocolitis infection | 32 (10.2) | 18 (11.8) | 14 (8.6) | |
| Biologic adverse events | ||||
| Alanine aminotransferase increased | 41 (13.0) | 18 (11.8) | 23 (14.2) | |
| Grade 3 | 25 (7.9) | 12 (7.8) | 13 (8.0) | |
| Grade ≥4 | 16 (5.1) | 6 (3.9) | 10 (6.2) | 0.36 |
| Hypokalemia | 36 (11.4) | 15 (9.8) | 21 (13.0) | |
| Grade 3 | 28 (8.9) | 11 (7.2) | 17 (10.5) | |
| Grade ≥4 | 8 (2.5) | 4 (2.6) | 4 (2.5) | 1.00 |
*
Shown are the numbers and percentages of patients who had at least one adverse event, those who had at least one adverse event of grade 4 or higher, and those who had the most frequent acute adverse events (i.e., events occurring in >10% of the patients overall). A total of 13 patients who did not have data on treatment or adverse events or who received only prephase treatment (a regimen of cyclophosphamide, vincristine, and prednisone [COP]) were not included in this analysis. Only nonhematologic adverse events of grade 3 or higher or cardiac adverse events of grade 2 or higher were recorded. P values are shown for events of grade 4 or higher.