Grade 3/4 treatment-emergent AEs (safety-evaluable population)
| Adverse event∗ . | Patients aged ≥60 y . | Patients aged ≥65 y . | Patients aged ≥70 y . | Patients aged ≥75 y . | ||||
|---|---|---|---|---|---|---|---|---|
| Pola-R-CHP (n = 306) . | R-CHOP (n = 317) . | Pola-R-CHP (n = 227) . | R-CHOP (n = 235) . | Pola-R-CHP (n = 137) . | R-CHOP (n = 143) . | Pola-R-CHP (n = 57) . | R-CHOP (n = 60) . | |
| Most common† | ||||||||
| Neutropenia | 90 (29.4) | 104 (32.8) | 69 (30.4) | 82 (34.9) | 42 (30.7) | 50 (35.0) | 16 (28.1) | 26 (43.3) |
| Febrile neutropenia | 50 (16.3) | 24 (7.6) | 40 (17.6) | 18 (7.7) | 29 (21.2) | 12 (8.4) | 12 (21.1) | 5 (8.3) |
| Anemia | 41 (13.4) | 34 (10.7) | 34 (15.0) | 22 (9.4) | 21 (15.3) | 14 (9.8) | 8 (14.0) | 8 (13.3) |
| Leukopenia | 19 (6.2) | 27 (8.5) | 17 (7.5) | 18 (7.7) | 10 (7.3) | 9 (6.3) | 5 (8.8) | 3 (5.0) |
| Diarrhea | 14 (4.6) | 7 (2.2) | 12 (5.3) | 5 (2.1) | 10 (7.3) | 4 (2.8) | 3 (5.3) | 3 (5.0) |
| Thrombocytopenia | 12 (3.9) | 15 (4.7) | 10 (4.4) | 11 (4.7) | 7 (5.1) | 6 (4.2) | 2 (3.5) | 6 (10.0) |
| Pneumonia | 11 (3.6) | 12 (3.8) | 9 (4.0) | 9 (3.8) | 5 (3.6) | 6 (4.2) | 4 (7.0) | 3 (5.0) |
| Lymphopenia | 7 (2.3) | 8 (2.5) | 7 (3.1) | 5 (2.1) | 5 (3.6) | 3 (2.1) | 2 (3.5) | 2 (3.3) |
| Syncope | 7 (2.3) | 8 (2.5) | 7 (3.1) | 8 (3.4) | 6 (4.4) | 6 (4.2) | 4 (7.0) | 4 (6.7) |
| Hyponatremia | 5 (1.6) | 7 (2.2) | 2 (0.9) | 6 (2.6) | 1 (0.7) | 3 (2.1) | 0 | 2 (3.3) |
| Fatigue | 4 (1.3) | 10 (3.2) | 4 (1.8) | 7 (3.0) | 4 (2.9) | 5 (3.5) | 3 (5.3) | 2 (3.3) |
| Hypertension | 3 (1.0) | 10 (3.2) | 3 (1.3) | 8 (3.4) | 2 (1.5) | 5 (3.5) | 1 (1.8) | 4 (6.7) |
| AEPI | ||||||||
| Infection | 43 (14.1) | 35 (11.0) | 35 (15.4) | 30 (12.8) | 22 (16.1) | 18 (12.6) | 13 (22.8) | 10 (16.7) |
| Urinary tract infection | 6 (2.0) | 5 (1.6) | 5 (2.2) | 4 (1.7) | 4 (2.9) | 3 (2.1) | 3 (5.3) | 2 (3.3) |
| Asthenia | 4 (1.3) | 1 (0.3) | 3 (1.3) | 1 (0.4) | 3 (2.2) | 1 (0.7) | 0 | 1 (1.7) |
| Peripheral neuropathy | 2 (0.7) | 3 (0.9) | 1 (0.4) | 3 (1.3) | 1 (0.7) | 1 (0.7) | 1 (1.8) | 1 (1.7) |
| Pyrexia | 2 (0.7) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sepsis | 1 (0.3) | 7 (2.2) | 1 (0.4) | 7 (3.0) | 1 (0.7) | 4 (2.8) | 1 (1.8) | 3 (5.0) |
| Septic shock | 0 | 1 (0.3) | 0 | 1 (0.4) | 0 | 1 (0.7) | 0 | 0 |
| Adverse event∗ . | Patients aged ≥60 y . | Patients aged ≥65 y . | Patients aged ≥70 y . | Patients aged ≥75 y . | ||||
|---|---|---|---|---|---|---|---|---|
| Pola-R-CHP (n = 306) . | R-CHOP (n = 317) . | Pola-R-CHP (n = 227) . | R-CHOP (n = 235) . | Pola-R-CHP (n = 137) . | R-CHOP (n = 143) . | Pola-R-CHP (n = 57) . | R-CHOP (n = 60) . | |
| Most common† | ||||||||
| Neutropenia | 90 (29.4) | 104 (32.8) | 69 (30.4) | 82 (34.9) | 42 (30.7) | 50 (35.0) | 16 (28.1) | 26 (43.3) |
| Febrile neutropenia | 50 (16.3) | 24 (7.6) | 40 (17.6) | 18 (7.7) | 29 (21.2) | 12 (8.4) | 12 (21.1) | 5 (8.3) |
| Anemia | 41 (13.4) | 34 (10.7) | 34 (15.0) | 22 (9.4) | 21 (15.3) | 14 (9.8) | 8 (14.0) | 8 (13.3) |
| Leukopenia | 19 (6.2) | 27 (8.5) | 17 (7.5) | 18 (7.7) | 10 (7.3) | 9 (6.3) | 5 (8.8) | 3 (5.0) |
| Diarrhea | 14 (4.6) | 7 (2.2) | 12 (5.3) | 5 (2.1) | 10 (7.3) | 4 (2.8) | 3 (5.3) | 3 (5.0) |
| Thrombocytopenia | 12 (3.9) | 15 (4.7) | 10 (4.4) | 11 (4.7) | 7 (5.1) | 6 (4.2) | 2 (3.5) | 6 (10.0) |
| Pneumonia | 11 (3.6) | 12 (3.8) | 9 (4.0) | 9 (3.8) | 5 (3.6) | 6 (4.2) | 4 (7.0) | 3 (5.0) |
| Lymphopenia | 7 (2.3) | 8 (2.5) | 7 (3.1) | 5 (2.1) | 5 (3.6) | 3 (2.1) | 2 (3.5) | 2 (3.3) |
| Syncope | 7 (2.3) | 8 (2.5) | 7 (3.1) | 8 (3.4) | 6 (4.4) | 6 (4.2) | 4 (7.0) | 4 (6.7) |
| Hyponatremia | 5 (1.6) | 7 (2.2) | 2 (0.9) | 6 (2.6) | 1 (0.7) | 3 (2.1) | 0 | 2 (3.3) |
| Fatigue | 4 (1.3) | 10 (3.2) | 4 (1.8) | 7 (3.0) | 4 (2.9) | 5 (3.5) | 3 (5.3) | 2 (3.3) |
| Hypertension | 3 (1.0) | 10 (3.2) | 3 (1.3) | 8 (3.4) | 2 (1.5) | 5 (3.5) | 1 (1.8) | 4 (6.7) |
| AEPI | ||||||||
| Infection | 43 (14.1) | 35 (11.0) | 35 (15.4) | 30 (12.8) | 22 (16.1) | 18 (12.6) | 13 (22.8) | 10 (16.7) |
| Urinary tract infection | 6 (2.0) | 5 (1.6) | 5 (2.2) | 4 (1.7) | 4 (2.9) | 3 (2.1) | 3 (5.3) | 2 (3.3) |
| Asthenia | 4 (1.3) | 1 (0.3) | 3 (1.3) | 1 (0.4) | 3 (2.2) | 1 (0.7) | 0 | 1 (1.7) |
| Peripheral neuropathy | 2 (0.7) | 3 (0.9) | 1 (0.4) | 3 (1.3) | 1 (0.7) | 1 (0.7) | 1 (1.8) | 1 (1.7) |
| Pyrexia | 2 (0.7) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sepsis | 1 (0.3) | 7 (2.2) | 1 (0.4) | 7 (3.0) | 1 (0.7) | 4 (2.8) | 1 (1.8) | 3 (5.0) |
| Septic shock | 0 | 1 (0.3) | 0 | 1 (0.4) | 0 | 1 (0.7) | 0 | 0 |