Table 2.
Adverse events summary
| Pooled RDE 5.6 mg/kg | All patients 3.2/4.8/5.6/6.4 mg/kg | |
|---|---|---|
| TEAEs | (n = 57), n (%) | (n = 81), n (%) |
| Any TEAE | 57 (100) | 81 (100) |
| Grade ≥3 TEAEs | 42 (74) | 52 (64) |
| Serious TEAEs | 25 (44) | 32 (40) |
| TEAEs associated with treatment discontinuation | 6 (11)a | 7 (9)b |
| TEAEs associated with dose reduction | 12 (21) | 18 (22) |
| TEAEs associated with dose interruption | 21 (37) | 30 (37) |
| TEAEs associated with death | 4 (7)c | 5 (6)d |
| Treatment-related TEAEs | 55 (96) | 78 (96) |
| Grade ≥3 treatment-related TEAEs | 31 (54) | 38 (47) |
| Treatment-related TEAEs associated with death | 0 | 0 |
| Serious treatment-related TEAEs | 12 (21) | 15 (19) |
| Grade ≥3 TEAEs occurring in ≥5% of patients | ||
| Platelet count decrease/thrombocytopenia | 17 (30) | 21 (26) |
| Neutrophil count decrease/neutropenia | 11 (19) | 12 (15) |
| Fatigue | 8 (14) | 8 (10) |
| Anemia/hemoglobin decrease | 5 (9) | 6 (7) |
| Dyspnea | 5 (9) | 5 (6) |
| Febrile neutropenia | 5 (9) | 5 (6) |
| Hypoxia | 4 (7) | 5 (6) |
| White blood cell count decrease/leukopenia | 4 (7) | 5 (6) |
| Hypokalemia | 3 (5) | 4 (5) |
| Lymphocyte count decrease/lymphopenia | 3 (5) | 4 (5) |
| Adjudicated ILD | 5 (9)e | 5 (6)e |
| Adjudicated treatment-related ILD | 4 (7)f | 4 (5)f |
aFatigue (two patients); decreased appetite, interstitial lung disease (ILD), neutrophil count decrease, pneumonitis, and upper respiratory tract infection (one patient each).
bFatigue (two patients); nausea, decreased appetite, ILD, neutrophil count decrease, pneumonitis, and upper respiratory tract infection (one patient each).
cTEAEs associated with death were respiratory failure (two patients) and disease progression and shock (one patient each).
dTEAEs associated with death were respiratory failure and disease progression (two patients each) and shock (one patient).
eTwo grade 1, one grade 2, one grade 3, and one grade 5.
fTwo grade 1, one grade 2, and one grade 3.