Pooled placebo (N=5) | Mezagitamab 45 mg (N=6) | Mezagitamab 90 mg (N=6) | Mezagitamab 135 mg (N=5) | |
Treatment compliance (%)* | ||||
Mean (SD) | 80.0 (20.9) | 79.2 (18.8) | 62.5 (34.5) | 70.0 (20.9) |
Median | 75.0 | 75.0 | 62.5 | 75.0 |
Min, Max | 50, 100 | 50, 100 | 25, 100 | 50, 100 |
TEAE | ||||
Any TEAE (% of patients) | 3 (60.0) | 4 (66.7) | 6 (100.0) | 2 (40.0) |
Grade 3 or higher TEAE | 0 | 0 | 0 | 0 |
Drug-related TEAE (% of patients) | 1 (20.0) | 1 (16.7) | 1 (16.7) | 1 (20.0) |
Drug-related grade 3 or higher TEAE | 0 | 0 | 0 | 0 |
Treatment-emergent SAEs (% of patients) | 0 | 1 (16.7) | 0 | 1 (20.0) |
Drug-related treatment-emergent SAEs | 0 | 0 | 0 | 0 |
TEAEs resulting in study drug dose modification† (% of patients) | 0 | 1 (16.7) | 0 | 1 (20.0) |
TEAEs resulting in study drug discontinuation (% of patients) | 0 | 0 | 0 | 1 (20.0) |
Deaths | 0 | 0 | 0 | 0 |
*Treatment compliance (%) was calculated as (actual number of doses taken)/(planned number of doses) × 100.
†Dose modification includes dose interrupted and drug withdrawn.
SAE, serious adverse event; TEAE, treatment-emergent adverse event.