Table 2 Overall AEs in FGF401 single agent and FGF401 + spartalizumab combination arm
Category | FGF401 single agent All patients N = 160 | FGF401 + spartalizumab All patients N = 12 | ||
|---|---|---|---|---|
All grades n (%) | Grade 3 or 4 n (%) | All grades n (%) | Grade 3 or 4 n (%) | |
AEs | 160 (100) | 116 (72.5) | 12 (100) | 6 (50.0) |
 Treatment related | 148 (92.5) | 51 (31.9) | 11 (91.7) | 4 (33.3) |
SAEs | 70 (43.8) | 55 (34.4) | 2 (16.7) | 2 (16.7) |
 Treatment related | 8 (5.0) | 7 (4.4) | 2 (16.7) | 1 (8.3) |
Fatal SAEs | 3 (1.9) | 3 (1.9) | 0 | 0 |
 Treatment related | 0 | 0 | 0 | 0 |
AEs leading to FGF401 discontinuation | 18 (11.3) | 13 (8.1) | 2 (16.7) | 1 (8.3) |
 Treatment related | 12 (7.5) | 8 (5.0) | 1 (8.3) | 0 |
AEs leading to FGF401 dose adjustment/interruption | 80 (50.0) | 58 (36.3) | 4 (33.3) | 3 (25.0) |
 Treatment related | 47 (29.4) | 34 (21.3) | 2 (16.7) | 2 (16.7) |