Table 1.
Safety summary from the ALEX study
| Safety population | Primary analysis 9 February 201711 |
Updated analysis 1 1 December 201725 |
Updated analysis 2 30 November 201840 |
Updated analysis 3 29 November 201910 |
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|---|---|---|---|---|---|---|---|---|
| Alectinib (n = 152) | Crizotinib (n = 151) | Alectinib (n = 152) | Crizotinib (n = 151) | Alectinib (n = 152) | Crizotinib (n = 151) | Alectinib (n = 152) | Crizotinib (n = 151) | |
| Median treatment duration, months (range) | 17.9 (0-29) | 10.7 (0-27) | 27.0 (0-39) | 10.8 (0-37) | 27.7 | 10.8 | 28.1 | 10.8 |
| Any grade AEs, n (%) | 147 (97) | 146 (97) | 147 (97) | 147 (97) | 147 (97) | 147 (97) | 147 (97) | 147 (97) |
| Serious AEs, n (%) | 43 (28) | 44 (29) | 46 (30) | 46 (31) | 54 (36) | 48 (32) | 59 (39) | 48 (32) |
| Grade 3-5 AEs, n (%) | 63 (41) | 76 (50) | 68 (45) | 77 (51) | 74 (49) | 83 (55) | 79 (52) | 85 (56) |
| Fatal AEs, n (%) | 5 (3) | 7 (5) | 6 (4) | 7 (5) | 6 (4) | 7 (5) | 7 (5) | 7 (5) |
| AEs leading to treatment discontinuation, n (%) | 17 (11) | 19 (13) | 20 (13) | 20 (13) | 21 (14) | 22 (15) | 22 (15) | 22 (15) |
| AEs leading to dose reduction, n (%) | 24 (16) | 31 (21) | 25 (16) | 31 (21) | 29 (19) | 30 (20) | 31 (20) | 30 (20) |
| AEs leading to dose interruption, n (%) | 29 (19) | 38 (25) | 34 (22) | 38 (25) | 38 (25) | 39 (26) | 40 (26) | 40 (27) |
AE, adverse event.