Table 2. Adverse Events Summary for Vistusertib Plus Anastrozole Arm vs Anastrozole Alone Arm for Treatment of Endometrial Cancer.
Incidence and type of adverse event | No. (%) | |||
---|---|---|---|---|
Vistusertib + anastrozole (n = 49) | Anastrozole (n = 24) | |||
Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 | |
Nausea | 25 (51) | 1 (2) | 2 (8) | 0 |
Fatigue | 34 (69) | 4 (8) | 7 (29) | 0 |
Vomiting | 11 (22) | 1 (2) | 1 (4) | 0 |
Diarrhea | 20 (41) | 1 (2) | 3 (13) | 0 |
Arthralgia | 11 (22) | 0 | 7 (29) | 0 |
Decrease in lymphocytes count | 17 (35) | 10 (20) | 3 (13) | 2 (8) |
Hyperglycemia | 15 (31) | 6 (12) | 2 (8) | 0 |
Anemia | 13 (27) | 2 (4) | 1 (4) | 0 |
≥1 SAE | 20 (41) | NA | 3 (13) | NA |
≥1 Vistusertib-related SAE | 11 (22) | NA | NA | NA |
Abbreviations: NA, not applicable; SAE, serious adverse event.