Table 2 Adverse events suspected to be study treatment-related (overall ≥10%; safety set)
Alpelisib 200 mg + Imatinib (N = 4) | Alpelisib 250 mg + Imatinib (N = 6) | Alpelisib 350 mg + Imatinib (N = 46) | Total (N = 56) | |||||
|---|---|---|---|---|---|---|---|---|
All grades, n (%) | Grade 3/4, n (%) | All grades, n (%) | Grade 3/4, n (%) | All grades, n (%) | Grade 3/4, n (%) | All grades, n (%) | Grade 3/4, n (%) | |
Total | 4 (100) | 2 (50.0) | 6 (100) | 3 (50.0) | 42 (91.3) | 21 (45.7) | 52 (92.9) | 26 (46.4) |
Hyperglycemia | 1 (25.0) | 0 | 1 (16.7) | 0 | 30 (65.2) | 13 (28.3) | 32 (57.1) | 13 (23.2) |
Diarrhea | 3 (75.0) | 1 (25.0) | 3 (50.0) | 0 | 21 (45.7) | 1 (2.2) | 27 (48.2) | 2 (3.6) |
Nausea | 2 (50.0) | 1 (25.0) | 3 (50.0) | 0 | 21 (45.7) | 1 (2.2) | 26 (46.4) | 2 (3.6) |
Decreased appetite | 2 (50.0) | 1 (25.0) | 1 (16.7) | 0 | 12 (26.1) | 3 (6.5) | 15 (26.8) | 4 (7.1) |
Vomiting | 1 (25.0) | 0 | 1 (16.7) | 0 | 12 (26.1) | 0 | 14 (25.0) | 0 |
Fatigue | 0 | 0 | 1 (16.7) | 1 (16.7) | 9 (19.6) | 1 (2.2) | 10 (17.9) | 2 (3.6) |
Edema peripheral | 0 | 0 | 0 | 0 | 9 (19.6) | 0 | 9 (16.1) | 0 |
Rash | 0 | 0 | 0 | 0 | 9 (19.6) | 1 (2.2) | 9 (16.1) | 1 (1.8) |
Asthenia | 2 (50.0) | 0 | 2 (33.3) | 0 | 4 (8.7) | 0 | 8 (14.3) | 0 |
Muscle spasms | 0 | 0 | 3 (50.0) | 0 | 5 (10.9) | 0 | 8 (14.3) | 0 |
Dysgeusia | 0 | 0 | 0 | 0 | 7 (15.2) | 0 | 7 (12.5) | 0 |
Rash maculo-papular | 0 | 0 | 0 | 0 | 7 (15.2) | 2 (4.3) | 7 (12.5) | 2 (3.6) |