Table 4.
a Most common adverse events and second primary malignancies reported during treatment in the safety population. b Most common adverse events of grade 3–4 reported during treatment in the safety population.
| No. (%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| All | Age ≤ 75 Years | Age >75 Years | |||||||
| TEAE or SPM | C-Rd (n = 143) | Rd (n = 143) | p | C-Rd (n = 65) | Rd (n = 59) | p | C-Rd (n = 78) | Rd (n = 84) | p |
| a | |||||||||
| Hematologic TEAEs, any grade | |||||||||
| Neutropenia | 34 (24) | 51 (36) | 0.038 | 15 (23) | 14 (24) | 1 | 19 (24) | 37 (44) | 0.013 |
| Anemia | 26 (18) | 28 (20) | 0.880 | 7 (14) | 8 (14) | 0.784 | 19 (24) | 20 (24) | 1 |
| Thrombocytopenia | 21 (15) | 22 (15) | 1 | 9 (14) | 7 (12) | 0.794 | 12 (15) | 15 (18) | 0.833 |
| Nonhematologic TEAEs, any grade | |||||||||
| Astenia | 40 (28) | 44 (31) | 0.697 | 17 (26) | 12 (20) | 0.526 | 23 (29) | 32 (38) | 0.319 |
| Steroid-related | 58 (41) | 40 (28) | 0.034 | 28 (34) | 17 (29) | 0.134 | 30 (38) | 23 (27) | 0.180 |
| Infections | 78 (55) | 76 (53) | 0.906 | 32 (49) | 28 (47) | 0.859 | 46 (59) | 48 (57) | 0.874 |
| Pneumonia | 11 (8) | 19 (13) | 0.176 | 6 (9) | 7 (12) | 0.771 | 5 (6) | 12 (14) | 0.127 |
| DVT and EP | 9 (6) | 11 (8) | 0.817 | 5 (8) | 5 (8) | 1 | 4 (5) | 6 (7) | 0.748 |
| Diarrhea | 22 (15) | 24 (17) | 0.872 | 10 (15) | 10 (17) | 1 | 12 (15) | 14 (17) | 0.834 |
| Invasive second primary cancer | 4 (3) | 1 (1) | 0.371 | 1.(1) | 0 (0) | 1 | 3 (4) | 1 (1) | 0.353 |
| b | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Hematologic TEAEs, any grade | |||||||||
| Neutropenia | 17 (12) | 28 (19) | 0.104 | 6 (9) | 7 (12) | 0.771 | 11 (14) | 21 (25) | 0.114 |
| Anemia | 4 (3) | 10 (7) | 0.169 | 1 (2) | 5 (8) | 0.101 | 3 (4) | 5 (6) | 0.721 |
| Thrombocytopenia | 7 (5) | 4 (3) | 0.541 | 2 (3) | 1 (2) | 1 | 5 (6) | 3 (3) | 0.483 |
| Nonhematologic TEAEs, any grade | |||||||||
| Astenia | 16 (11) | 4 (3) | 0.009 | 5 (8) | 1 (2) | 0.211 | 11 (14) | 3 (3) | 0.024 |
| Steroid-related | 22 (15) | 9 (6) | 0.021 | 7 (11) | 5 (8) | 0.766 | 15 (19) | 4 (5) | 0.006 |
| Infections | 43 (30) | 36 (25) | 0.428 | 17 (26) | 15 (25) | 1 | 26 (33) | 21 (25) | 0.299 |
| Pneumonia | 10 (7) | 14 (10) | 0.523 | 6 (9) | 6 (10) | 1 | 4 (5) | 8 (9) | 0.373 |
| DVT and EP | 2 (1) | 6 (4) | 0.282 | 0 (0) | 4 (7) | 0.049 | 2 (2) | 2 (2) | 1 |
| Diarrhea | 4 (3) | 5 (3) | 1 | 2 (3) | 2 (3) | 1 | 2 (2) | 3 (3) | 1 |
| Invasive second primary cancer | 4 (3) | 1 (1) | 0.371 | 1 (1) | 0 (0) | 1 | 3 (4) | 1 (1) | 0.353 |