Safety summary (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) . | |
| AEs | ||||||||
| Any grade | 301 (98.4) | 312 (98.4) | 223 (98.2) | 232 (98.7) | 136 (99.3) | 142 (99.3) | 57 (100) | 60 (100) |
| Grade 3-4 | 192 (62.7) | 195 (61.5) | 150 (66.1) | 153 (65.1) | 101 (73.7) | 98 (68.5) | 40 (70.2) | 48 (80.0) |
| Grade 5 | 11 (3.6) | 10 (3.2) | 9 (4.0) | 9 (3.8) | 5 (3.6) | 7 (4.9) | 2 (3.5) | 2 (3.3) |
| SAEs | 113 (36.9) | 101 (31.9) | 89 (39.2) | 81 (34.5) | 59 (43.1) | 55 (38.5) | 26 (45.6) | 24 (40.0) |
| Related to any study drug | 86 (28.1) | 67 (21.1) | 66 (29.1) | 53 (22.6) | 48 (35.0) | 35 (24.5) | 20 (35.1) | 18 (30.0) |
| AE leading to | ||||||||
| Study discontinuation | 11 (3.6) | 10 (3.2) | 9 (4.0) | 9 (3.8) | 5 (3.6) | 7 (4.9) | 2 (3.5) | 2 (3.3) |
| Discontinuation of polatuzumab vedotin/vincristine | 17 (5.6) | 19 (6.0) | 15 (6.6) | 15 (6.4) | 11 (8.0) | 6 (4.2) | 4 (7.0) | 3 (5.0) |
| Dose reduction of polatuzumab vedotin/vincristine | 18 (5.9) | 33 (10.4) | 11 (4.8) | 21 (8.9) | 9 (6.6) | 17 (11.9) | 4 (7.0) | 9 (15.0) |
| Interruption of polatuzumab vedotin/vincristine | 57 (18.6) | 56 (17.7) | 42 (18.5) | 43 (18.3) | 27 (19.7) | 31 (21.7) | 13 (22.8) | 12 (20.0) |
| 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) . | |
| AEs | ||||||||
| Any grade | 301 (98.4) | 312 (98.4) | 223 (98.2) | 232 (98.7) | 136 (99.3) | 142 (99.3) | 57 (100) | 60 (100) |
| Grade 3-4 | 192 (62.7) | 195 (61.5) | 150 (66.1) | 153 (65.1) | 101 (73.7) | 98 (68.5) | 40 (70.2) | 48 (80.0) |
| Grade 5 | 11 (3.6) | 10 (3.2) | 9 (4.0) | 9 (3.8) | 5 (3.6) | 7 (4.9) | 2 (3.5) | 2 (3.3) |
| SAEs | 113 (36.9) | 101 (31.9) | 89 (39.2) | 81 (34.5) | 59 (43.1) | 55 (38.5) | 26 (45.6) | 24 (40.0) |
| Related to any study drug | 86 (28.1) | 67 (21.1) | 66 (29.1) | 53 (22.6) | 48 (35.0) | 35 (24.5) | 20 (35.1) | 18 (30.0) |
| AE leading to | ||||||||
| Study discontinuation | 11 (3.6) | 10 (3.2) | 9 (4.0) | 9 (3.8) | 5 (3.6) | 7 (4.9) | 2 (3.5) | 2 (3.3) |
| Discontinuation of polatuzumab vedotin/vincristine | 17 (5.6) | 19 (6.0) | 15 (6.6) | 15 (6.4) | 11 (8.0) | 6 (4.2) | 4 (7.0) | 3 (5.0) |
| Dose reduction of polatuzumab vedotin/vincristine | 18 (5.9) | 33 (10.4) | 11 (4.8) | 21 (8.9) | 9 (6.6) | 17 (11.9) | 4 (7.0) | 9 (15.0) |
| Interruption of polatuzumab vedotin/vincristine | 57 (18.6) | 56 (17.7) | 42 (18.5) | 43 (18.3) | 27 (19.7) | 31 (21.7) | 13 (22.8) | 12 (20.0) |
SAE, serious adverse event.
Data are presented as n (%).