Treatment-emergent AEs (safety-evaluable population)
| AEs, n (%) . | Pola-R-CHP (n = 140) . | R-CHOP (n = 139) . |
|---|---|---|
| Any grade | 139 (99.3) | 138 (99.3) |
| Grade ≥3 | 104 (74.3) | 93 (66.9) |
| Serious | 46 (32.9) | 45 (32.4) |
| Grade 5 | 2 (1.4) | 1 (0.7) |
| Most common any-grade AEs∗ , n (%) | ||
| Anemia | 61 (43.6) | 55 (39.6) |
| Alopecia | 56 (40.0) | 51 (36.7) |
| Neutrophil count decreased† | 50 (35.7) | 48 (34.5) |
| White blood cell count decreased† | 52 (37.1) | 43 (30.9) |
| Peripheral sensory neuropathy | 41 (29.3) | 49 (35.3) |
| Neutropenia | 47 (33.6) | 40 (28.8) |
| Nausea | 44 (31.4) | 38 (27.3) |
| Constipation | 33 (23.6) | 39 (28.1) |
| Platelet count decreased | 32 (22.9) | 31 (22.3) |
| Leukopenia | 29 (20.7) | 31 (22.3) |
| ALT increased | 27 (19.3) | 26 (18.7) |
| Pyrexia | 25 (17.9) | 27 (19.4) |
| Decreased appetite | 28 (20.0) | 23 (16.5) |
| Lymphocyte count decreased† | 25 (17.9) | 26 (18.7) |
| Weight decreased | 21 (15.0) | 24 (17.3) |
| Diarrhea | 25 (17.9) | 18 (12.9) |
| Pneumonia | 22 (15.7) | 21 (15.1) |
| AST increased | 21 (15.0) | 21 (15.1) |
| Thrombocytopenia | 23 (16.4) | 17 (12.2) |
| Hypokalemia | 13 (9.3) | 21 (15.1) |
| AEs, n (%) . | Pola-R-CHP (n = 140) . | R-CHOP (n = 139) . |
|---|---|---|
| Any grade | 139 (99.3) | 138 (99.3) |
| Grade ≥3 | 104 (74.3) | 93 (66.9) |
| Serious | 46 (32.9) | 45 (32.4) |
| Grade 5 | 2 (1.4) | 1 (0.7) |
| Most common any-grade AEs∗ , n (%) | ||
| Anemia | 61 (43.6) | 55 (39.6) |
| Alopecia | 56 (40.0) | 51 (36.7) |
| Neutrophil count decreased† | 50 (35.7) | 48 (34.5) |
| White blood cell count decreased† | 52 (37.1) | 43 (30.9) |
| Peripheral sensory neuropathy | 41 (29.3) | 49 (35.3) |
| Neutropenia | 47 (33.6) | 40 (28.8) |
| Nausea | 44 (31.4) | 38 (27.3) |
| Constipation | 33 (23.6) | 39 (28.1) |
| Platelet count decreased | 32 (22.9) | 31 (22.3) |
| Leukopenia | 29 (20.7) | 31 (22.3) |
| ALT increased | 27 (19.3) | 26 (18.7) |
| Pyrexia | 25 (17.9) | 27 (19.4) |
| Decreased appetite | 28 (20.0) | 23 (16.5) |
| Lymphocyte count decreased† | 25 (17.9) | 26 (18.7) |
| Weight decreased | 21 (15.0) | 24 (17.3) |
| Diarrhea | 25 (17.9) | 18 (12.9) |
| Pneumonia | 22 (15.7) | 21 (15.1) |
| AST increased | 21 (15.0) | 21 (15.1) |
| Thrombocytopenia | 23 (16.4) | 17 (12.2) |
| Hypokalemia | 13 (9.3) | 21 (15.1) |
AEs are MedDRA version 24.0 preferred terms.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; MedDRA, Medical Dictionary for Regulatory Activities.
Most common was defined as all-grade AEs occurring in ≥15% of patients in any treatment arm.
Finding based on laboratory test results indicating a decrease in the number of neutrophils, white blood cells, or lymphocyte count in a blood specimen. Please note that for the AE, neutrophil count decreased, the term “neutropenia” may also have been listed by investigators.