Table 3.
Summary of safety (AEs by preferred term reported by ≥ 5% of patients; safety population)
| Variable | R-CHOP (N = 701) n (%) | G-CHOP (N = 702) n (%) | ||
|---|---|---|---|---|
| No. of deaths (any reason) | 141 (20.1) | 149 (21.2) | ||
| No. of patients withdrawn from the study due to an AE | 4 (0.6) | 6 (0.9) | ||
| Patients with ≥ 1 | ||||
| AE | 659 (94.0) | 685 (97.6) | ||
| Grade 3–5 AE | 461 (65.8) | 527 (75.1) | ||
| AE with fatal outcomea | 31 (4.4) | 43 (6.1) | ||
| Serious AE | 269 (38.4) | 312 (44.4) | ||
| Treatment-related AE | 600 (85.6) | 647 (92.2) | ||
| AE leading to withdrawal of any treatment | 58 (8.3) | 8.7 (12.4) | ||
| AE leading to dose reduction for any treatment | 142 (20.3) | 145 (20.7) | ||
| Grade 3–5 AE, n (%) | Serious AE, n (%) | Grade 3–5 AE, n (%) | Serious AE, n (%) | |
| Blood and lymphatic system disorders | ||||
| Neutropenia | 277 (39.5) | 38 (5.4) | 336 (47.9) | 54 (7.7) |
| Febrile neutropenia | 108 (15.4) | 71 (10.1) | 130 (18.5) | 85 (12.1) |
| Leukopenia | 78 (11.1) | – | 104 (14.8) | – |
| Anemia | 55 (7.8) | – | 53 (7.5) | – |
| Thrombocytopenia | 11 (1.6) | – | 40 (5.7) | – |
| Infections and infestations | ||||
| Pneumonia | 34 (4.9) | 33 (4.7) | 44 (6.3) | 43 (6.1) |
AE adverse event, G-CHOP obinutuzumab plus cyclophosphamide, doxorubicin, vincristine, and prednisone, R-CHOP rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone
aFatal AEs that occurred in more than one patient in either group, listed as preferred terms, were as follows: death (cause unknown; 2 patients in the R-CHOP arm and 3 patients in the G-CHOP arm), pneumonia (5 patients in each arm), septic shock (6 patients in the G-CHOP arm), sepsis (3 patients in the R-CHOP arm and 1 patient in the G-CHOP arm), hepatocellular carcinoma (1 patient in the R-CHOP arm and 2 patients in the G-CHOP arm), cerebrovascular accident (2 patients in each arm), and pulmonary embolism (2 patients in the G-CHOP group)