TEAEs and laboratory abnormalities occurring in >20% of patients (all grades) or ≥5% (grade 3/4)
| . | All-grade/grade 3/4 events, no. of patients . | All patients (n =57), n (%) . | |||||
|---|---|---|---|---|---|---|---|
| 3 mg/kg Q2W (n = 4) . | 5 mg/kg Q2W (n = 3) . | 10 mg/kg Q2W (n = 24) . | 10 mg/kg QW/Q2W (n = 12) . | 20 mg/kg QW/Q2W (n = 14) . | All grades . | Grade 3/4 . | |
| TEAE | |||||||
| Any event | 4/3 | 3/3 | 24/21 | 12/10 | 14/13 | 57 (100) | 50 (88) |
| Diarrhea | 3/0 | 2/0 | 15/0 | 4/0 | 6/0 | 30 (53) | 0 |
| Fatigue | 3/1 | 2/0 | 12/1 | 5/2 | 6/0 | 28 (49) | 4 (7) |
| URTI | 2/0 | 2/0 | 10/0 | 6/0 | 3/0 | 23 (40) | 0 |
| Nausea | 2/0 | 2/0 | 11/0 | 1/0 | 4/0 | 20 (35) | 0 |
| Insomnia | 2/0 | 2/0 | 9/1 | 2/0 | 3/0 | 18 (32) | 1 (2) |
| Pyrexia | 1/0 | 0/0 | 8/0 | 5/0 | 4/0 | 18 (32) | 0 |
| Dyspnea | 0/0 | 0/0 | 9/0 | 2/0 | 5/2 | 16 (28) | 2 (4) |
| Cough | 3/0 | 1/0 | 6/0 | 2/0 | 3/0 | 15 (26) | 0 |
| Headache | 1/0 | 0/0 | 5/0 | 4/0 | 3/0 | 13 (23) | 0 |
| Muscle spasms | 2/0 | 2/0 | 6/0 | 2/0 | 1/0 | 13 (23) | 0 |
| Vomiting | 1/0 | 1/0 | 8/0 | 1/0 | 2/0 | 13 (23) | 0 |
| Hypokalemia | 0/0 | 0/0 | 5/1 | 3/1 | 4/1 | 12 (21) | 3 (5) |
| Nasal congestion | 1/0 | 0/0 | 4/0 | 3/0 | 4/0 | 12 (21) | 0 |
| Pneumonia | 0/0 | 1/1 | 1/1 | 1/1 | 2/2 | 5 (9) | 5 (9) |
| Lung infection | 0/0 | 0/0 | 3/2 | 0/0 | 1/1 | 4 (7) | 3 (5) |
| Anaphylactic reaction | 1/1 | 0/0 | 0/0 | 0/0 | 2/2 | 3 (5) | 3 (5) |
| Febrile neutropenia | 0/0 | 0/0 | 3/3 | 0/0 | 0/0 | 3 (5) | 3 (5) |
| Laboratory abnormalities* | |||||||
| Anemia | 4/0 | 3/0 | 23/9 | 12/2 | 12/3 | 54 (98) | 14 (25) |
| Lymphopenia | 2/0 | 3/1 | 23/16 | 11/6 | 12/9 | 52 (95) | 32 (58) |
| Neutropenia | 3/3 | 3/2 | 22/12 | 11/8 | 10/8 | 49 (89) | 33 (60) |
| Leukopenia | 3/1 | 3/1 | 23/13 | 11/7 | 10/7 | 50 (91) | 29 (53) |
| Thrombocytopenia | 3/2 | 3/1 | 23/13 | 12/0 | 9/5 | 50 (91) | 21 (38) |
| . | All-grade/grade 3/4 events, no. of patients . | All patients (n =57), n (%) . | |||||
|---|---|---|---|---|---|---|---|
| 3 mg/kg Q2W (n = 4) . | 5 mg/kg Q2W (n = 3) . | 10 mg/kg Q2W (n = 24) . | 10 mg/kg QW/Q2W (n = 12) . | 20 mg/kg QW/Q2W (n = 14) . | All grades . | Grade 3/4 . | |
| TEAE | |||||||
| Any event | 4/3 | 3/3 | 24/21 | 12/10 | 14/13 | 57 (100) | 50 (88) |
| Diarrhea | 3/0 | 2/0 | 15/0 | 4/0 | 6/0 | 30 (53) | 0 |
| Fatigue | 3/1 | 2/0 | 12/1 | 5/2 | 6/0 | 28 (49) | 4 (7) |
| URTI | 2/0 | 2/0 | 10/0 | 6/0 | 3/0 | 23 (40) | 0 |
| Nausea | 2/0 | 2/0 | 11/0 | 1/0 | 4/0 | 20 (35) | 0 |
| Insomnia | 2/0 | 2/0 | 9/1 | 2/0 | 3/0 | 18 (32) | 1 (2) |
| Pyrexia | 1/0 | 0/0 | 8/0 | 5/0 | 4/0 | 18 (32) | 0 |
| Dyspnea | 0/0 | 0/0 | 9/0 | 2/0 | 5/2 | 16 (28) | 2 (4) |
| Cough | 3/0 | 1/0 | 6/0 | 2/0 | 3/0 | 15 (26) | 0 |
| Headache | 1/0 | 0/0 | 5/0 | 4/0 | 3/0 | 13 (23) | 0 |
| Muscle spasms | 2/0 | 2/0 | 6/0 | 2/0 | 1/0 | 13 (23) | 0 |
| Vomiting | 1/0 | 1/0 | 8/0 | 1/0 | 2/0 | 13 (23) | 0 |
| Hypokalemia | 0/0 | 0/0 | 5/1 | 3/1 | 4/1 | 12 (21) | 3 (5) |
| Nasal congestion | 1/0 | 0/0 | 4/0 | 3/0 | 4/0 | 12 (21) | 0 |
| Pneumonia | 0/0 | 1/1 | 1/1 | 1/1 | 2/2 | 5 (9) | 5 (9) |
| Lung infection | 0/0 | 0/0 | 3/2 | 0/0 | 1/1 | 4 (7) | 3 (5) |
| Anaphylactic reaction | 1/1 | 0/0 | 0/0 | 0/0 | 2/2 | 3 (5) | 3 (5) |
| Febrile neutropenia | 0/0 | 0/0 | 3/3 | 0/0 | 0/0 | 3 (5) | 3 (5) |
| Laboratory abnormalities* | |||||||
| Anemia | 4/0 | 3/0 | 23/9 | 12/2 | 12/3 | 54 (98) | 14 (25) |
| Lymphopenia | 2/0 | 3/1 | 23/16 | 11/6 | 12/9 | 52 (95) | 32 (58) |
| Neutropenia | 3/3 | 3/2 | 22/12 | 11/8 | 10/8 | 49 (89) | 33 (60) |
| Leukopenia | 3/1 | 3/1 | 23/13 | 11/7 | 10/7 | 50 (91) | 29 (53) |
| Thrombocytopenia | 3/2 | 3/1 | 23/13 | 12/0 | 9/5 | 50 (91) | 21 (38) |
TEAE, treatment-emergent adverse event; URTI, upper respiratory tract infection.
Data on laboratory abnormalities were not available for 2 patients in the 20 mg/kg QW/Q2W cohort (lab data available for 20 mg/kg cohort, n = 12; all patients, n = 55).