Table 3.
Overview of treatment‐emergent adverse events (any grade and grade 3/4) by study phase and dose
| n (%) | Phase 1 | Phase 2 | ||||
|---|---|---|---|---|---|---|
| 10 mg/kg QW/Q2W (n = 3) | 20 mg/kg QW/Q2W (n = 5) | 20 mg/kg QW/Q2W (n = 28) | ||||
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Any TEAE | 3 (100) | 1 (33) | 4 (80) | 2 (40) | 25 (89) | 12 (43) |
| Drug‐related TEAE | 2 (67) | 1 (33) | 1 (20) | 0 | 18 (64) | 3 (11) |
| Serious TEAE | 1 (33) | 1 (20) | 7 (25) | |||
| Serious drug‐related TEAE | 1 (33) | 0 | 2 (7) | |||
| TEAE leading to death | 0 | 1 (20) | 0 | |||
| TEAE leading to discontinuation | 0 | 1 (20) | 2 (7) | |||
| At least one DLT | 0 | 0 | – | |||
| At least one infusion‐related reaction | 2 (67) | 0 | 1 (20) | 0 | 12 (43) | 0 |
| TEAEs in ≥1 patient in phase 1 or ≥5% of patients in phase 2 | ||||||
| Infusion‐related reactions | 2 (67) | 0 | 1 (20) | 0 | 12 (43) | 0 |
| Pyrexia | 0 | 0 | 0 | 0 | 6 (21) | 1 (4) |
| Nasopharyngitis | 2 (67) | 0 | 1 (20) | 0 | 6 (21) | 0 |
| Vomiting | 1 (33) | 0 | 2 (40) | 0 | 1 (4) | 0 |
| Pneumonia | 1 (33) | 1 (33) | 1 (20) | 1 (20) | 3 (11) | 2 (7) |
| Rhinorrhea | 1 (33) | 0 | 1 (20) | 0 | 3 (11) | 0 |
| Cataract | 1 (33) | 0 | 0 | 0 | 3 (11) | 1 (4) |
| Diarrhea | 1 (33) | 0 | 0 | 0 | 3 (11) | 0 |
| Influenza | 0 | 0 | 0 | 0 | 2 (7) | 0 |
| Pharyngitis | 1 (33) | 0 | 0 | 0 | 2 (7) | 0 |
| Sinusitis | 1 (33) | 0 | 0 | 0 | 2 (7) | 0 |
| Leukopenia | 1 (33) | 0 | 0 | 0 | 2 (7) | 1 (4) |
| Back pain | 1 (33) | 0 | 0 | 0 | 4 (14) | 0 |
| Deep vein thrombosis | 1 (33) | 1 (33) | 0 | 0 | 1 (4) | 0 |
| Lymphopenia | 1 (33) | 1 (33) | 0 | 0 | 1 (4) | 0 |
| Hypertension | 1 (33) | 0 | 0 | 0 | 1 (4) | 1 (4) |
| Upper respiratory tract infection | 1 (33) | 0 | 0 | 0 | 1 (4) | 0 |
| Cough | 1 (33) | 0 | 0 | 0 | 1 (4) | 0 |
| Conjunctivitis | 1 (33) | 0 | 0 | 0 | 0 | 0 |
| Bone pain | 1 (33) | 0 | 0 | 0 | 0 | 0 |
| Dermatitis contact | 1 (33) | 0 | 0 | 0 | 0 | 0 |
| Nausea | 0 | 0 | 1 (20) | 0 | 2 (7) | 0 |
| Upper respiratory tract inflammation | 0 | 0 | 1 (20) | 0 | 1 (4) | 0 |
| Platelet count decreased | 0 | 0 | 1 (20) | 0 | 1 (4) | 0 |
| Diplegia | 0 | 0 | 1 (20) | 1 (20) | 0 | 0 |
| Neurogenic bladder | 0 | 0 | 1 (20) | 1 (20) | 0 | 0 |
| Disease progression | 0 | 0 | 1 (20) | 1 (20) | 0 | 0 |
| Vertigo | 0 | 0 | 1 (20) | 0 | 0 | 0 |
| Hot flush | 0 | 0 | 1 (20) | 0 | 0 | 0 |
| Pathological fracture | 0 | 0 | 1 (20) | 0 | 0 | 0 |
| Fatigue | 0 | 0 | 1 (20) | 0 | 0 | 0 |
| Edema peripheral | 0 | 0 | 0 | 0 | 3 (11) | 1 (4) |
| Bronchitis | 0 | 0 | 0 | 0 | 2 (7) | 0 |
| Chest discomfort | 0 | 0 | 0 | 0 | 2 (7) | 0 |
| Chills | 0 | 0 | 0 | 0 | 2 (7) | 0 |
| Decreased appetite | 0 | 0 | 0 | 0 | 2 (7) | 0 |
| Hypoxia | 0 | 0 | 0 | 0 | 2 (7) | 0 |
| Nasal congestion | 0 | 0 | 0 | 0 | 2 (7) | 0 |
| Pruritus | 0 | 0 | 0 | 0 | 2 (7) | 0 |
| Rhinitis allergic | 0 | 0 | 0 | 0 | 2 (7) | 0 |
| Stomatitis | 0 | 0 | 0 | 0 | 2 (7) | 0 |
Abbreviations: DLT, dose‐limiting toxicity; Q2W, every 2 weeks; QW, every week; TEAE, treatment‐emergent adverse event.