Percentages of patients with at least one grade 3 adverse event observed within the first 6 courses of chemotherapy according to randomization group
| . | ChOP5-150 (%) . | CAP5-151(%) . | FAMP5-152 (%) . | P . |
|---|---|---|---|---|
| Biologic events | ||||
| Anemia | 57 (16) | 25 (10) | 57 (18) | .04 |
| AIHA | 3 (1) | 0 | 6 (2) | .07 |
| Neutropenia | 131 (38) | 71 (30) | 122 (38) | .06 |
| Thrombocytopenia5-153 | 29 (8) | 18 (7) | 49 (15) | .003 |
| ALT or AST ≥ twice baseline | 1 (1) | 2 (1) | 4 (1) | .40 |
| Clinical events | ||||
| Hemorrhage | 4 (2) | 0 | 2 (1) | .23 |
| Nausea, vomiting | 6 (1) | 13 (5) | 3 (1) | .003 |
| Alopecia | 54 (16) | 35 (15) | 0 | < .0001 |
| Infection5-155 | 17 (5) | 10 (4) | 16 (5) | .90 |
| Unexplained fever | 0 | 1 (1) | 7 (4) | .05 |
| Cardiac disorder | 2 (1) | 4 (2) | 0 | .04 |
| Neurologic disorder5-154 | 1 (1) | 2 (1) | 0 | .27 |
| Hospitalizations | 66 (19) | 32 (15) | 74 (23) | .06 |
| . | ChOP5-150 (%) . | CAP5-151(%) . | FAMP5-152 (%) . | P . |
|---|---|---|---|---|
| Biologic events | ||||
| Anemia | 57 (16) | 25 (10) | 57 (18) | .04 |
| AIHA | 3 (1) | 0 | 6 (2) | .07 |
| Neutropenia | 131 (38) | 71 (30) | 122 (38) | .06 |
| Thrombocytopenia5-153 | 29 (8) | 18 (7) | 49 (15) | .003 |
| ALT or AST ≥ twice baseline | 1 (1) | 2 (1) | 4 (1) | .40 |
| Clinical events | ||||
| Hemorrhage | 4 (2) | 0 | 2 (1) | .23 |
| Nausea, vomiting | 6 (1) | 13 (5) | 3 (1) | .003 |
| Alopecia | 54 (16) | 35 (15) | 0 | < .0001 |
| Infection5-155 | 17 (5) | 10 (4) | 16 (5) | .90 |
| Unexplained fever | 0 | 1 (1) | 7 (4) | .05 |
| Cardiac disorder | 2 (1) | 4 (2) | 0 | .04 |
| Neurologic disorder5-154 | 1 (1) | 2 (1) | 0 | .27 |
| Hospitalizations | 66 (19) | 32 (15) | 74 (23) | .06 |
ALT indicates alanine aminotransferase; AST, aspartate aminotransferase.
Total, 357.
Total, 240.
Total, 341.
Two patients (one in the ChOP group, one in the FAMP group) discontinued treatment after a single course due to thrombocytopenic purpura.
One patient stopped treatment due to severe pneumonia after one course of CAP.
One patient discontinued treatment due to encephalopathy after one course of CAP.