Table 2.
Treatment-emergent adverse events reported in ≥10% of patients in the total study population (n = 32)
| Treatment-emergent adverse events | All grades n (%) |
Grade 3/4 n (%) |
|---|---|---|
| Hematologic | ||
| Neutropenia | 7 (22) | 2/1 (9) |
| Leukopeniaa | 3 (9) | 3/0 (9) |
| Gastrointestinal | ||
| Anorexia | 28 (88) | 0 |
| Constipation | 4 (13) | 0 |
| Diarrhea | 19 (59) | 0 |
| Nausea | 22 (69) | 0 |
| Vomiting | 6 (19) | 0 |
| Dehydration | 4 (13) | 1/0 (3) |
| Constitutional symptoms | ||
| Insomnia | 9 (28) | 0 |
| Chills | 26 (81) | 0 |
| Fatigue | 29 (91) | 3/0 (9) |
| Influenza-like illness | 6 (19) | 0 |
| Night sweats | 4 (13) | 0 |
| Fever | 27 (84) | 0 |
| Metabolic/laboratory | ||
| Alanine aminotransferase | 9 (28) | 4/0 (13) |
| Aspartate aminotransferase | 6 (19) | 2/0 (6) |
| Triglyceride elevations | 22 (69) | 3/4 (22) |
| Pain | ||
| Headache | 23 (72) | 0 |
| Arthralgia | 5 (16) | 0 |
| Back | 7 (22) | 0 |
| Myalgia | 18 (56) | 0 |
| Neurology | ||
| Dizziness | 4 (13) | 0 |
| Anxiety | 7 (22) | 0 |
| Somnolence | 5 (16) | 0 |
| Depression | 11 (34) | 0 |
| Psychiatric | ||
| Insomnia | 9 (28) | 0 |
| Sexual/reproductive function | ||
| Erectile dysfunction | 4 (13) | 0 |
| Pulmonary/upper respiratory | ||
| Cough | 12 (38) | 0 |
| Dyspnea | 7 (22) | 0 |
| Skin/dermatology | ||
| Injection site reaction | 6 (19) | 0 |
| Pruritus | 7 (22) | 0 |
| Rash | 8 (25) | 1/0 (3) |
aLeukopenia occurred at a frequency of <10% but is included as a treatment-emergent adverse event of interest