Table 3.
Adverse Events During the Entire Treatment Period for All Patients (those with follicular lymphoma and with nonfollicular lymphoma)*
| Adverse Event | All Grades |
Grade 3 to 4 |
||
|---|---|---|---|---|
| Obinutuzumab (n = 87) No. (%) | Rituximab (n = 86) No. (%) | Obinutuzumab (n = 87) No. (%) | Rituximab (n = 86) No. (%) | |
| Infusion-related reaction† | 64 (74) | 44 (51) | 10 (11) | 4 (5) |
| Fatigue | 23 (26) | 17 (20) | — | — |
| Cough‡ | 21 (24) | 8 (9) | — | — |
| Upper respiratory tract infection | 9 (10) | 9 (10) | — | — |
| Pyrexia | 6 (7) | 9 (10) | 1 (1) | — |
| Headache | 8 (9) | 7 (8) | — | — |
| Nausea | 8 (9) | 6 (7) | — | — |
| Diarrhea | 7 (8) | 7 (8) | — | — |
| Arthralgia | 4 (5) | 8 (9) | — | — |
| Decreased appetite | 8 (9) | 3 (3) | — | — |
| Asthenia | 6 (7) | 5 (6) | — | — |
| Neutropenia | 3 (3) | 7 (8) | 3 (3) | 6 (7) |
| Dizziness | 4 (5) | 6 (7) | — | — |
| Back pain | 7 (8) | 3 (3) | — | — |
| Bronchitis | 7 (8) | 3 (3) | — | — |
| Peripheral edema | 6 (7) | 4 (5) | — | — |
| Nasopharyngitis | 6 (7) | 4 (5) | — | — |
| Sinusitis | 6 (7) | 4 (5) | — | — |
| Hypertension | 2 (2) | 7(8) | — | — |
| Rash | 6 (7) | 3 (3) | — | — |
| Upper abdominal pain | 2 (2) | 6 (7) | — | — |
*
Occurring in more than five patients in either treatment arm. Unless otherwise noted, the adverse event proportions between the two treatment arms were not significantly different (Fisher's exact P value [two-sided] > .05).
†
Fisher's exact P value (two-sided) =.003
‡
Fisher's exact P value (two-sided) =.013