Table 2.
All grade ≥2 ipatasertib-related AEs in >5% of patients
| Number (%) of patients by ipatasertib daily dosea | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse event | 25 mg (n = 3) |
50 mg (n = 3) |
100 mg (n = 3) |
200 mg (n = 3) |
400 mg (n = 3) |
600 mg (n = 29) |
800 mg (n = 7) |
All subjects (n = 51) |
| Any AEb,c | 0 | 2 (67) | 1 (33) | 1 (33) | 2 (67) | 21 (72) | 7 (100) | 34 (67) |
| Diarrhea | 0 | 0 | 0 | 0 | 0 | 14 (48) | 4 (57) | 18 (35) |
| Nausea | 0 | 0 | 0 | 0 | 1 (33) | 7 (24) | 6 (86) | 14 (27) |
| Asthenia | 0 | 2 (67) | 1 (33) | 1 (33) | 0 | 5 (17) | 4 (57) | 13 (25) |
| Hyperglycemia | 0 | 0 | 0 | 0 | 0 | 3 (10) | 2 (29) | 5 (10) |
| Decreased appetite | 0 | 0 | 0 | 0 | 0 | 2 (7) | 1 (14) | 3 (6) |
| Rash | 0 | 0 | 0 | 0 | 0 | 1 (3) | 2 (29) | 3 (6) |
| Vomiting | 0 | 0 | 0 | 0 | 0 | 1 (3) | 2 (29) | 3 (6) |
Abbreviation: n, number of patients.
Patients are categorized by initial dose cohort assignment, regardless of subsequent dose modification.
Grade 3 AEs that were assessed by the investigators as related to ipatasertib were diarrhea (n = 4 at 600 mg, 8%), asthenia (n = 3 at 600 mg and 800 mg, 6%), hypercholesterolemia (n = 1 at 100 mg, 2%), hyperglycemia (n = 1 at 600 mg, 2%), hypophosphatemia (n = 1 at 600 mg, 2%), nausea (n =1 at 800 mg, 2%), and toxic skin eruption (n = 1 at 600 mg, 2%).
Serious adverse events that were assessed by the investigators as related to ipatasertib were grade 3 asthenia (n = 1 at 800 mg, 2%), grade 3 diarrhea (n = 1 at 600 mg, 2%), grade 3 hyperglycemia (n = 1 at 600 mg, 2%), grade 3 toxic skin eruption (n = 1 at 600 mg, 2%), and grade 2 renal failure (n = 1 at 600 mg, 2%).