Table 3.
Safety and Tolerability
| Parameter, n (%)* | All Patients (N = 152) |
|---|---|
| Death | 0 |
| SAEs | 1 (1)† |
| AE leading to discontinuation | 0 |
| Grade 3 AEs | 3 (2)‡ |
| Grade 4 AEs | 0 |
| AEs in ≥5% of patients (all grades) | |
| Headache | 30 (20) |
| Fatigue | 29 (19) |
| Nausea | 18 (12) |
| Diarrhea | 13 (9) |
| Insomnia | 9 (6) |
| Abdominal pain | 8 (5) |
| Arthralgia | 8 (5) |
| Grade 3/4 laboratory abnormalities§ | |
| Hgb <9.0 g/dL | 0 |
| Absolute neutrophils <0.75 × 109 cells/L | 0 |
| Absolute lymphocytes <0.5 × 109 cells/L | 1 (1) |
| PLTs <50 × 109 cells/L | 2 (1) |
| INR >2× ULN | 2 (1) |
| ALT >5× ULN | 0 |
| AST >5× ULN | 0 |
| Total bilirubin >2.5× ULN | 0 |
| Lipase >3× ULN | 3 (2) |
*
On-treatment events for death and AEs; treatment-emergent events for grade 3/4 laboratory abnormalities.
†
One event of gastrointestinal hemorrhage at week 2, considered not related to study treatment.
‡
Arthralgia in 1 patient; food poisoning, nausea, and vomiting in 1 patient; and SAE of gastrointestinal hemorrhage in 1 patient.
§
Primarily transient increases or decreases that were not present for prolonged periods during treatment.
Abbreviation: ULN, upper limit of normal.