Table 3 Patients who had grade 3/4 AEs, SAEs, AEs leading to discontinuation, or other significant AEs (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 (%) | |
AEs | 4 (100) | 4 (100) | 6 (100) | 5 (83.3) | 46 (100) | 33 (71.7) | 56 (100) | 42 (75.0) |
Suspected to be study treatment-related | 4 (100) | 2 (50.0) | 6 (100) | 3 (50.0) | 42 (91.3) | 21 (45.7) | 52 (92.9) | 26 (46.4) |
SAEs | 1 (25.0) | 1 (25.0) | 4 (66.7) | 3 (50.0) | 25 (54.3) | 21 (45.7) | 30 (53.6) | 25 (44.6) |
Suspected to be study treatment-related | 1 (25.0) | 1 (25.0) | 0 | 0 | 7 (15.2) | 6 (13.0) | 8 (14.3) | 7 (12.5) |
AEs leading to discontinuations | 1 (25.0) | 1 (25.0) | 1 (16.7) | 1 (16.7) | 10 (21.7) | 8 (17.4) | 12 (21.4) | 10 (17.9) |
Suspected to be study treatment-related | 1 (25.0) | 1 (25.0) | 0 | 0 | 5 (10.9) | 3 (6.5) | 6 (10.7) | 4 (7.1) |
AEs requiring dose interruptions and/or change | 2 (50.0) | 2 (50.0) | 3 (50.0) | 2 (33.3) | 30 (65.2) | 22 (47.8) | 35 (62.5) | 26 (46.4) |
Suspected to be study treatment-related | 2 (50.0) | 2 (50.0) | 1 (16.7) | 0 | 22 (47.8) | 14 (30.4) | 25 (44.6) | 16 (28.6) |
AEs requiring additional therapy | 4 (100) | 3 (75.0) | 6 (100) | 4 (66.7) | 46 (100) | 29 (63.0) | 56 (100) | 36 (64.3) |
Suspected to be study treatment-related | 4 (100) | 2 (50.0) | 3 (50.0) | 0 | 39 (84.8) | 18 (39.1) | 46 (82.1) | 20 (35.7) |