Treatment-emergent AEs (safety population)
| Patients, n (%) . | R/R (N = 45) . | 1L (N = 32) . | ||
|---|---|---|---|---|
| All grade . | Grade 3-4 . | All grade . | Grade 3-4 . | |
| AEs occurring in ≥20% of patients | ||||
| Diarrhea | 31 (69) | 3 (7) | 18 (56) | 1 (3) |
| Infusion-related reaction | 29 (64) | 2 (4) | 22 (69) | 0 |
| Neutropenia | 29 (64) | 26 (58) | 21 (66) | 17 (53) |
| Fatigue | 24 (53) | 1 (2) | 14 (44) | 1 (3) |
| Nausea | 23 (51) | 0 | 22 (69) | 0 |
| Cough | 22 (49) | 0 | 11 (34) | 0 |
| Pyrexia | 20 (44) | 0 | 15 (47) | 1 (3) |
| Anemia | 19 (42) | 2 (4) | 9 (28) | 1 (3) |
| Chills | 16 (36) | 0 | 11 (34) | 0 |
| Thrombocytopenia | 15 (33) | 10 (22) | 14 (44) | 7 (22) |
| Headache | 15 (33) | 0 | 12 (38) | 0 |
| Vomiting | 14 (31) | 1 (2) | 11 (34) | 0 |
| Dyspnea | 12 (27) | 0 | 9 (28) | 0 |
| Arthralgia | 12 (27) | 0 | 3 (9) | 0 |
| Dizziness | 10 (22) | 0 | 6 (19) | 0 |
| Constipation | 9 (20) | 0 | 8 (25) | 0 |
| Hyperphosphatemia | 9 (20) | 1 (2) | 2 (6) | 0 |
| Rash | 8 (18) | 0 | 7 (22) | 0 |
| Abdominal pain | 6 (13) | 0 | 8 (25) | 0 |
| Hypotension | 5 (11) | 0 | 7 (22) | 0 |
| Flushing | 4 (9) | 0 | 10 (31) | 0 |
| Chest discomfort | 4 (9) | 0 | 7 (22) | 0 |
| Dyspepsia | 4 (9) | 0 | 7 (22) | 0 |
| Infection AEs occurring in >5% of patients | ||||
| Infections and infestations (system organ class) | 38 (84) | 13 (29) | 26 (81) | 4 (13) |
| Upper respiratory tract infection | 17 (38) | 1 (2) | 6 (19) | 0 |
| Sinusitis | 12 (27) | 0 | 5 (16) | 0 |
| Pneumonia | 7 (16) | 5 (11) | 1 (3) | 0 |
| Lower respiratory tract infection | 6 (13) | 2 (4) | 2 (6) | 0 |
| Cellulitis | 5 (11) | 4 (9) | 1 (3) | 0 |
| Rhinovirus infection | 5 (11) | 0 | 0 | 0 |
| Urinary tract infection | 4 (9) | 2 (4) | 4 (13) | 0 |
| Influenza | 4 (9) | 1 (2) | 2 (6) | 0 |
| Herpes zoster | 3 (7) | 0 | 1 (3) | 0 |
| Diverticulitis | 2 (4) | 0 | 2 (6) | 1 (3) |
| Bronchitis | 2 (4) | 0 | 3 (9) | 0 |
| Skin infection | 2 (4) | 0 | 2 (6) | 0 |
| Nasopharyngitis | 2 (4) | 0 | 2 (6) | 0 |
| Respiratory syncytial virus infection | 1 (2) | 0 | 2 (6) | 0 |
| Fungal skin infection | 0 | 0 | 2 (6) | 0 |
| Patients, n (%) . | R/R (N = 45) . | 1L (N = 32) . | ||
|---|---|---|---|---|
| All grade . | Grade 3-4 . | All grade . | Grade 3-4 . | |
| AEs occurring in ≥20% of patients | ||||
| Diarrhea | 31 (69) | 3 (7) | 18 (56) | 1 (3) |
| Infusion-related reaction | 29 (64) | 2 (4) | 22 (69) | 0 |
| Neutropenia | 29 (64) | 26 (58) | 21 (66) | 17 (53) |
| Fatigue | 24 (53) | 1 (2) | 14 (44) | 1 (3) |
| Nausea | 23 (51) | 0 | 22 (69) | 0 |
| Cough | 22 (49) | 0 | 11 (34) | 0 |
| Pyrexia | 20 (44) | 0 | 15 (47) | 1 (3) |
| Anemia | 19 (42) | 2 (4) | 9 (28) | 1 (3) |
| Chills | 16 (36) | 0 | 11 (34) | 0 |
| Thrombocytopenia | 15 (33) | 10 (22) | 14 (44) | 7 (22) |
| Headache | 15 (33) | 0 | 12 (38) | 0 |
| Vomiting | 14 (31) | 1 (2) | 11 (34) | 0 |
| Dyspnea | 12 (27) | 0 | 9 (28) | 0 |
| Arthralgia | 12 (27) | 0 | 3 (9) | 0 |
| Dizziness | 10 (22) | 0 | 6 (19) | 0 |
| Constipation | 9 (20) | 0 | 8 (25) | 0 |
| Hyperphosphatemia | 9 (20) | 1 (2) | 2 (6) | 0 |
| Rash | 8 (18) | 0 | 7 (22) | 0 |
| Abdominal pain | 6 (13) | 0 | 8 (25) | 0 |
| Hypotension | 5 (11) | 0 | 7 (22) | 0 |
| Flushing | 4 (9) | 0 | 10 (31) | 0 |
| Chest discomfort | 4 (9) | 0 | 7 (22) | 0 |
| Dyspepsia | 4 (9) | 0 | 7 (22) | 0 |
| Infection AEs occurring in >5% of patients | ||||
| Infections and infestations (system organ class) | 38 (84) | 13 (29) | 26 (81) | 4 (13) |
| Upper respiratory tract infection | 17 (38) | 1 (2) | 6 (19) | 0 |
| Sinusitis | 12 (27) | 0 | 5 (16) | 0 |
| Pneumonia | 7 (16) | 5 (11) | 1 (3) | 0 |
| Lower respiratory tract infection | 6 (13) | 2 (4) | 2 (6) | 0 |
| Cellulitis | 5 (11) | 4 (9) | 1 (3) | 0 |
| Rhinovirus infection | 5 (11) | 0 | 0 | 0 |
| Urinary tract infection | 4 (9) | 2 (4) | 4 (13) | 0 |
| Influenza | 4 (9) | 1 (2) | 2 (6) | 0 |
| Herpes zoster | 3 (7) | 0 | 1 (3) | 0 |
| Diverticulitis | 2 (4) | 0 | 2 (6) | 1 (3) |
| Bronchitis | 2 (4) | 0 | 3 (9) | 0 |
| Skin infection | 2 (4) | 0 | 2 (6) | 0 |
| Nasopharyngitis | 2 (4) | 0 | 2 (6) | 0 |
| Respiratory syncytial virus infection | 1 (2) | 0 | 2 (6) | 0 |
| Fungal skin infection | 0 | 0 | 2 (6) | 0 |
Data include all investigator-reported AEs, regardless of relationship to study drug. AEs occurring in ≥20% of patients are listed by Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT). Infection AEs occurring in >5% patients are listed by MedDRA system organ class and PT.