TABLE 2.
Most frequent treatment‐emergent adverse events (TEAEs) [≥20% (all grades) or any (grade ≥ 3)] (safety analysis set)
| TEAE, n (%) |
Cohort 1 60 mg/d (n = 3) |
Cohort 2 90 mg/d (n = 11) |
Cohort 3 120 mg/d (n = 4) |
Total (n = 18) | ||||
|---|---|---|---|---|---|---|---|---|
| All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |
| Nausea | 3 (100.0) | 0 (0.0) | 7 (63.6) | 0 (0.0) | 3 (75.0) | 0 (0.0) | 13 (72.2) | 0 (0.0) |
| Platelet count decreased | 0 (0.0) | 0 (0.0) | 8 (72.7) | 1 (9.1) | 3 (75.0) | 3 (75.0) | 11 (61.1) | 4 (22.2) |
| Decreased appetite | 2 (66.7) | 0 (0.0) | 6 (54.5) | 0 (0.0) | 3 (75.0) | 0 (0.0) | 11 (61.1) | 0 (0.0) |
| Fatigue | 2 (66.7) | 0 (0.0) | 6 (54.5) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 9 (50.0) | 0 (0.0) |
| Anemia | 0 (0.0) | 0 (0.0) | 7 (63.6) | 3 (27.3) | 2 (50.0) | 0 (0.0) | 9 (50.0) | 3 (16.7) |
| White blood cell count decreased | 1 (33.3) | 0 (0.0) | 6 (54.5) | 0 (0.0) | 2 (50.0) | 1 (25.0) | 9 (50.0) | 1 (5.6) |
| Hypoalbuminemia | 1 (33.3) | 0 (0.0) | 6 (54.5) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 8 (44.4) | 0 (0.0) |
| Hyponatremia | 0 (0.0) | 0 (0.0) | 3 (27.3) | 1 (9.1) | 2 (50.0) | 1 (25.0) | 5 (27.8) | 2 (11.1) |
| Neutrophil count decreased | 0 (0.0) | 0 (0.0) | 3 (27.3) | 0 (0.0) | 2 (50.0) | 1 (25.0) | 5 (27.8) | 1 (5.6) |
| Constipation | 2 (66.7) | 0 (0.0) | 2 (18.2) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 5 (27.8) | 0 (0.0) |
| Diarrhea | 0 (0.0) | 0 (0.0) | 3 (27.3) | 0 (0.0) | 2 (50.0) | 0 (0.0) | 5 (27.8) | 0 (0.0) |
| Vomiting | 0 (0.0) | 0 (0.0) | 3 (27.3) | 0 (0.0) | 2 (50.0) | 0 (0.0) | 5 (27.8) | 0 (0.0) |
| Aspartate aminotransferase increased | 0 (0.0) | 0 (0.0) | 2 (18.2) | 0 (0.0) | 2 (50.0) | 1 (25.0) | 4 (22.2) | 1 (5.6) |
| Alanine aminotransferase increased | 1 (33.3) | 0 (0.0) | 1 (9.1) | 1 (9.1) | 2 (50.0) | 1 (25.0) | 4 (22.2) | 2 (11.1) |
| Lymphocyte count decreased | 1 (33.3) | 0 (0.0) | 1 (9.1) | 0 (0.0) | 2 (50.0) | 1 (25.0) | 4 (22.2) | 1 (5.6) |
| Pyrexia | 0 (0.0) | 0 (0.0) | 3 (27.3) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 4 (22.2) | 0 (0.0) |
| Sepsis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (25.0) | 1 (25.0) | 1 (5.6) | 1 (5.6) |
| Urinary tract infection | 0 (0.0) | 0 (0.0) | 1 (9.1) | 1 (9.1) | 0 (0.0) | 0 (0.0) | 1 (5.6) | 1 (5.6) |
| Lymphangiosis carcinomatosa | 1 (33.3) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.6) | 1 (5.6) |
| Hypophosphataemic rickets | 0 (0.0) | 0 (0.0) | 1 (9.1) | 1 (9.1) | 0 (0.0) | 0 (0.0) | 1 (5.6) | 1 (5.6) |
| Jaundice cholestatic | 0 (0.0) | 0 (0.0) | 1 (9.1) | 1 (9.1) | 0 (0.0) | 0 (0.0) | 1 (5.6) | 1 (5.6) |
| Disease progression | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (25.0) | 1 (25.0) | 1 (5.6) | 1 (5.6) |
Coded with Medical Dictionary for Regulatory Activities Version 18.0.