Table 2.
AEs Causally Linked to Study Treatment (>10% of Patients) and Grade ≥3 AEs (>2 Patients)
| AE by Preferred Term |
Capivasertib Monotherapy Breast-Specific Cohort (N=20) |
Capivasertib + Fulvestrant Combination (N=44)a |
Total (N=64)a |
|||
|---|---|---|---|---|---|---|
| All grades | Grade ≥3 | All grades | Grade ≥3 | All grades | Grade ≥3 | |
| Any AE (causally related to capivasertib), n (%) | 19 (95) | 10 (50) | 38 (86) | 9 (21) | 57 (89) | 19 (30) |
| Diarrhea | 13 (65) | 2 (10) | 26 (59) | 2 (5) | 39 (61) | 4 (6) |
| Nausea | 10 (50) | 0 | 13 (30) | 1 (2) | 23 (36) | 1 (2) |
| Hyperglycemia | 9 (45) | 6 (30) | 8 (18) | 2 (5) | 17 (27) | 8 (13) |
| Vomiting | 9 (45) | 0 | 7 (16) | 0 | 16 (25) | 0 |
| Fatigue | 8 (40) | 0 | 8 (18) | 1 (2) | 16 (25) | 1 (2) |
| Rash maculopapular | 6 (30) | 4 (20) | 9 (21) | 4 (9) | 15 (23) | 8 (13) |
| Decreased appetite | 3 (15) | 0 | 7 (16) | 1 (2) | 10 (16) | 1 (2) |
| Stomatitis | 4 (20) | 0 | 6 (14) | 0 | 10 (16) | 0 |
| Dry skin | 4 (20) | 0 | 3 (7) | 0 | 7 (11) | 0 |
| Abdominal pain | 4 (20) | 0 | 2 (5) | 0 | 6 (9) | 0 |
| Dizziness | 4 (20) | 0 | 2 (5) | 0 | 6 (9) | 0 |
| Pruritus | 3 (15) | 0 | 3 (7) | 0 | 6 (9) | 0 |
| Dry mouth | 4 (20) | 0 | 0 | 0 | 4 (6) | 0 |
Includes AEs with an onset date on or after the date of first dose and up to and including 28 days following the date of last dose of study. A patient is only counted once for each preferred term.
a
Includes one non-AKT1E17K patient excluded from the efficacy analyses, who was enrolled based on an AKT1E40K mutation detected by local NGS. AE, adverse event; NGS, next-generation sequencing.