Most common AEs reported in the safety population
| AE, n (%) . | D-R (n = 96) . | R (n = 98) . | ||
|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| Hematologic | ||||
| Neutropenia | 62 (64.6) | 45 (46.9) | 60 (61.2) | 41 (41.8) |
| Leukopenia | 25 (26.0) | 9 (9.4) | 29 (29.6) | 6 (6.1) |
| Thrombocytopenia | 23 (24.0) | 3 (3.1) | 28 (28.6) | 2 (2.0) |
| Lymphopenia | 23 (24.0) | 10 (10.4) | 13 (13.3) | 5 (5.1) |
| Anemia | 22 (22.9) | 4 (4.2) | 17 (17.3) | 3 (3.1) |
| Nonhematologic | ||||
| Diarrhea | 59 (61.5) | 3 (3.1) | 54 (55.1) | 5 (5.1) |
| Fatigue | 44 (45.8) | 2 (2.1) | 46 (46.9) | 3 (3.1) |
| Upper respiratory tract infection | 40 (41.7) | 0 | 26 (26.5) | 0 |
| Cough | 37 (38.5) | 0 | 36 (36.7) | 0 |
| Hypokalemia | 33 (34.4) | 7 (7.3) | 36 (36.7) | 6 (6.1) |
| Arthralgia | 32 (33.3) | 1 (1.0) | 36 (36.7) | 1 (1.0) |
| Back pain | 31 (32.3) | 0 | 20 (20.4) | 1 (1.0) |
| COVID-19 | 28 (29.2) | 1 (1.0) | 29 (29.6) | 3 (3.1) |
| Nausea | 26 (27.1) | 0 | 26 (26.5) | 0 |
| Nasal congestion | 25 (26.0) | 0 | 19 (19.4) | 0 |
| Headache | 24 (25.0) | 1 (1.0) | 17 (17.3) | 0 |
| Constipation | 22 (22.9) | 0 | 26 (26.5) | 0 |
| Muscle spasms | 22 (22.9) | 0 | 21 (21.4) | 0 |
| Pain in extremity | 22 (22.9) | 1 (1.0) | 17 (17.3) | 0 |
| Maculopapular rash | 21 (21.9) | 1 (1.0) | 17 (17.3) | 2 (2.0) |
| Hypertension | 14 (14.6) | 7 (7.3) | 10 (10.2) | 4 (4.1) |
| Pneumonia | 10 (10.4) | 5 (5.2) | 14 (14.3) | 4 (4.1) |
| Infusion-related reactions | 13 (13.5) | 0 | N/A | N/A |
| AE, n (%) . | D-R (n = 96) . | R (n = 98) . | ||
|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| Hematologic | ||||
| Neutropenia | 62 (64.6) | 45 (46.9) | 60 (61.2) | 41 (41.8) |
| Leukopenia | 25 (26.0) | 9 (9.4) | 29 (29.6) | 6 (6.1) |
| Thrombocytopenia | 23 (24.0) | 3 (3.1) | 28 (28.6) | 2 (2.0) |
| Lymphopenia | 23 (24.0) | 10 (10.4) | 13 (13.3) | 5 (5.1) |
| Anemia | 22 (22.9) | 4 (4.2) | 17 (17.3) | 3 (3.1) |
| Nonhematologic | ||||
| Diarrhea | 59 (61.5) | 3 (3.1) | 54 (55.1) | 5 (5.1) |
| Fatigue | 44 (45.8) | 2 (2.1) | 46 (46.9) | 3 (3.1) |
| Upper respiratory tract infection | 40 (41.7) | 0 | 26 (26.5) | 0 |
| Cough | 37 (38.5) | 0 | 36 (36.7) | 0 |
| Hypokalemia | 33 (34.4) | 7 (7.3) | 36 (36.7) | 6 (6.1) |
| Arthralgia | 32 (33.3) | 1 (1.0) | 36 (36.7) | 1 (1.0) |
| Back pain | 31 (32.3) | 0 | 20 (20.4) | 1 (1.0) |
| COVID-19 | 28 (29.2) | 1 (1.0) | 29 (29.6) | 3 (3.1) |
| Nausea | 26 (27.1) | 0 | 26 (26.5) | 0 |
| Nasal congestion | 25 (26.0) | 0 | 19 (19.4) | 0 |
| Headache | 24 (25.0) | 1 (1.0) | 17 (17.3) | 0 |
| Constipation | 22 (22.9) | 0 | 26 (26.5) | 0 |
| Muscle spasms | 22 (22.9) | 0 | 21 (21.4) | 0 |
| Pain in extremity | 22 (22.9) | 1 (1.0) | 17 (17.3) | 0 |
| Maculopapular rash | 21 (21.9) | 1 (1.0) | 17 (17.3) | 2 (2.0) |
| Hypertension | 14 (14.6) | 7 (7.3) | 10 (10.2) | 4 (4.1) |
| Pneumonia | 10 (10.4) | 5 (5.2) | 14 (14.3) | 4 (4.1) |
| Infusion-related reactions | 13 (13.5) | 0 | N/A | N/A |
AEs of any grade that occurred in ≥20% of patients and grade 3/4 AEs that occurred in ≥5% of patients in either treatment group.
N/A, not applicable.