Table 2.
Summary of treatment-emergent adverse events that occurred in 3 or more patients throughout the study (Safety analysis set)
| MedDRA Preferred term | Treatment-emergent | Efatutazone-related | ||
|---|---|---|---|---|
| Overall | Grade 3 or higher | Overall | Grade 3 or higher | |
| Hematotoxicity | ||||
| Neutropenia | 15 (100.0) | 14 (93.3) | 7 (46.7) | 6 (40.0) |
| Leukopenia | 14 (93.3) | 7 (46.7) | 6 (40.0) | 2 (13.3) |
| Anemia | 13 (86.7) | 5 (33.3) | 11 (73.3) | 4 (26.7) |
| Thrombocytopenia | 10 (66.7) | 1 (6.7) | 3 (20.0) | 1 (6.7) |
| Non-hematotoxicity | ||||
| Weight increase | 15 (100.0) | 0 | 15 (100.0) | 0 |
| Edema | 12 (80.0) | 1 (6.7) | 10 (66.7) | 1 (6.7) |
| Nausea | 9 (60.0) | 0 | 0 | 0 |
| Vomiting | 8 (53.3) | 0 | 0 | 0 |
| Alopecia | 8 (53.3) | 0 | 0 | 0 |
| Fatigue | 8 (53.3) | 1 (6.7) | 3 (20.0) | 1 (6.7) |
| Decreased appetite | 7 (46.7) | 1 (6.7) | 2 (13.3) | 0 |
| Diarrhea | 7 (46.7) | 0 | 1 (6.7) | 0 |
| Hypoalbuminemia | 6 (40.0) | 2 (13.3) | 2 (13.3) | 0 |
| Constipation | 5 (33.3) | 0 | 3 (20.0) | 0 |
| Blood alkaline phosphatase increased | 5 (33.3) | 1 (6.7) | 0 | 0 |
| Blood creatinine increased | 5 (33.3) | 0 | 1 (6.7) | 0 |
| Hypercholesterolemia | 4 (26.7) | 1 (6.7) | 3 (20.0) | 0 |
| Hyponatremia | 4 (26.7) | 1 (6.7) | 4 (26.7) | 1 (6.7) |
| Abdominal pain | 4 (26.7) | 1 (6.7) | 2 (13.3) | 0 |
| Pyrexia | 4 (26.7) | 0 | 1 (6.7) | 0 |
| Gamma-glutamyltransferase increased | 4 (26.7) | 2 (13.3) | 0 | 0 |
| Nasopharyngitis | 3 (20.0) | 0 | 1 (6.7) | 0 |
| Stomatitis | 3 (20.0) | 0 | 1 (6.7) | 0 |
| Malaise | 3 (20.0) | 1 (6.7) | 2 (13.3) | 1 (6.7) |
| Aspartate aminotransferase increased | 3 (20.0) | 0 | 0 | 0 |
Values represent the number (%) of subjects
MedDRA Medical Dictionary for Regulatory Activities