Most common treatment-emergent AEs with at least 10% incidence and SAEs (at least 5% incidence; safety-evaluable population)
| . | Pola-M-CHP, n = 38 . | Pola-R-CHP, n = 22 . | ||
|---|---|---|---|---|
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Most common AEs (≥10% of patients) based on preferred term | ||||
| CRS | 26 (68.4) | 1 (2.6) | 0 | 0 |
| Nausea | 17 (44.7) | 0 | 9 (40.9) | 0 |
| Neutropenia/neutrophil count decreased | 23 (63.2) | 25 (63.2) | 12 (54.5) | 9 (40.9) |
| Diarrhea | 13 (34.2) | 3 (7.9) | 4 (18.2) | 0 |
| Fatigue | 12 (31.6) | 1 (2.6) | 10 (45.5) | 0 |
| Decreased appetite | 12 (31.6) | 1 (2.6) | 1 (4.5) | 1 (4.5) |
| Anemia | 10 (26.3) | 5 (13.2) | 5 (22.7) | 2 (9.1) |
| Alanine aminotransferase increased | 10 (26.3) | 2 (5.3) | 4 (18.2) | 1 (4.5) |
| Vomiting | 9 (23.7) | 0 | 5 (22.7) | 0 |
| Infusion-related reaction | 9 (23.7) | 0 | 2 (9.1) | 0 |
| Alopecia | 7 (18.4) | 0 | 9 (40.9) | 0 |
| Abdominal pain | 7 (18.4) | 1 (2.6) | 1 (4.5) | 0 |
| Constipation | 6 (15.8) | 0 | 4 (18.2) | 0 |
| Dyspepsia | 6 (15.8) | 0 | 0 | 0 |
| Thrombocytopenia | 6 (15.8) | 3 (7.9) | 1 (4.5) | 0 |
| Rash | 6 (15.8) | 0 | 4 (18.2) | 0 |
| Increased white blood cell count | 6 (15.8) | 4 (10.5) | 3 (13.6) | 2 (9.1) |
| Febrile neutropenia | 5 (13.2) | 5 (13.2) | 2 (9.1) | 2 (9.1) |
| Peripheral sensory neuropathy | 5 (13.2) | 0 | 4 (18.2) | 0 |
| Peripheral edema | 5 (13.2) | 0 | 0 | 0 |
| Pyrexia | 5 (13.2) | 0 | 0 | 0 |
| Back pain | 5 (13.2) | 0 | 3 (13.6) | 0 |
| Infection | 4 (10.5) | 3 (7.9) | 1 (4.5) | 1 (4.5) |
| Pruritus | 4 (10.5) | 0 | 1 (4.5) | 0 |
| Hypokalemia | 4 (10.5) | 0 | 1 (4.5) | 1 (4.5) |
| Hypomagnesemia | 4 (10.5) | 0 | 0 | 0 |
| Hypophosphatemia | 4 (10.5) | 0 | 1 (4.5) | 0 |
| Dyspnea | 4 (10.5) | 1 (2.6) | 3 (13.6) | 0 |
| Decreased weight | 4 (10.5) | 1 (2.6) | 1 (4.5) | 0 |
| Increased aspartate aminotransferase | 4 (10.5) | 3 (7.9) | 2 (9.1) | 1 (4.5) |
| Decreased platelet count | 4 (10.5) | 4 (10.5) | 3 (13.6) | 0 |
| Peripheral neuropathy | 3 (7.9) | 0 | 4 (18.2) | 0 |
| Headache | 2 (5.3) | 0 | 7 (31.8) | 0 |
| Insomnia | 2 (5.3) | 0 | 6 (27.3) | 0 |
| Most common SAEs (≥5% of patients) based on preferred term | ||||
| Febrile neutropenia | 5 (13.2) | 5 (13.2) | 1 (4.5) | 1 (4.5) |
| CRS | 5 (13.2) | 1 (2.6) | 0 | 0 |
| Infection not otherwise specified | 3 (7.9) | 3 (7.9) | 1 (4.5) | 1 (4.5) |
| Diarrhea | 3 (7.9) | 2 (5.3) | 0 | 0 |
| Anemia | 2 (5.3) | 2 (5.3) | 0 | 0 |
| Herpes zoster | 2 (5.3) | 1 (2.6) | 0 | 0 |
| Death | 2 (5.3) | 2 (5.3) | 0 | 0 |
| . | Pola-M-CHP, n = 38 . | Pola-R-CHP, n = 22 . | ||
|---|---|---|---|---|
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Most common AEs (≥10% of patients) based on preferred term | ||||
| CRS | 26 (68.4) | 1 (2.6) | 0 | 0 |
| Nausea | 17 (44.7) | 0 | 9 (40.9) | 0 |
| Neutropenia/neutrophil count decreased | 23 (63.2) | 25 (63.2) | 12 (54.5) | 9 (40.9) |
| Diarrhea | 13 (34.2) | 3 (7.9) | 4 (18.2) | 0 |
| Fatigue | 12 (31.6) | 1 (2.6) | 10 (45.5) | 0 |
| Decreased appetite | 12 (31.6) | 1 (2.6) | 1 (4.5) | 1 (4.5) |
| Anemia | 10 (26.3) | 5 (13.2) | 5 (22.7) | 2 (9.1) |
| Alanine aminotransferase increased | 10 (26.3) | 2 (5.3) | 4 (18.2) | 1 (4.5) |
| Vomiting | 9 (23.7) | 0 | 5 (22.7) | 0 |
| Infusion-related reaction | 9 (23.7) | 0 | 2 (9.1) | 0 |
| Alopecia | 7 (18.4) | 0 | 9 (40.9) | 0 |
| Abdominal pain | 7 (18.4) | 1 (2.6) | 1 (4.5) | 0 |
| Constipation | 6 (15.8) | 0 | 4 (18.2) | 0 |
| Dyspepsia | 6 (15.8) | 0 | 0 | 0 |
| Thrombocytopenia | 6 (15.8) | 3 (7.9) | 1 (4.5) | 0 |
| Rash | 6 (15.8) | 0 | 4 (18.2) | 0 |
| Increased white blood cell count | 6 (15.8) | 4 (10.5) | 3 (13.6) | 2 (9.1) |
| Febrile neutropenia | 5 (13.2) | 5 (13.2) | 2 (9.1) | 2 (9.1) |
| Peripheral sensory neuropathy | 5 (13.2) | 0 | 4 (18.2) | 0 |
| Peripheral edema | 5 (13.2) | 0 | 0 | 0 |
| Pyrexia | 5 (13.2) | 0 | 0 | 0 |
| Back pain | 5 (13.2) | 0 | 3 (13.6) | 0 |
| Infection | 4 (10.5) | 3 (7.9) | 1 (4.5) | 1 (4.5) |
| Pruritus | 4 (10.5) | 0 | 1 (4.5) | 0 |
| Hypokalemia | 4 (10.5) | 0 | 1 (4.5) | 1 (4.5) |
| Hypomagnesemia | 4 (10.5) | 0 | 0 | 0 |
| Hypophosphatemia | 4 (10.5) | 0 | 1 (4.5) | 0 |
| Dyspnea | 4 (10.5) | 1 (2.6) | 3 (13.6) | 0 |
| Decreased weight | 4 (10.5) | 1 (2.6) | 1 (4.5) | 0 |
| Increased aspartate aminotransferase | 4 (10.5) | 3 (7.9) | 2 (9.1) | 1 (4.5) |
| Decreased platelet count | 4 (10.5) | 4 (10.5) | 3 (13.6) | 0 |
| Peripheral neuropathy | 3 (7.9) | 0 | 4 (18.2) | 0 |
| Headache | 2 (5.3) | 0 | 7 (31.8) | 0 |
| Insomnia | 2 (5.3) | 0 | 6 (27.3) | 0 |
| Most common SAEs (≥5% of patients) based on preferred term | ||||
| Febrile neutropenia | 5 (13.2) | 5 (13.2) | 1 (4.5) | 1 (4.5) |
| CRS | 5 (13.2) | 1 (2.6) | 0 | 0 |
| Infection not otherwise specified | 3 (7.9) | 3 (7.9) | 1 (4.5) | 1 (4.5) |
| Diarrhea | 3 (7.9) | 2 (5.3) | 0 | 0 |
| Anemia | 2 (5.3) | 2 (5.3) | 0 | 0 |
| Herpes zoster | 2 (5.3) | 1 (2.6) | 0 | 0 |
| Death | 2 (5.3) | 2 (5.3) | 0 | 0 |
Data presented as n (%).