Table 2.
AEs reported in ≥10% of patients in the alectinib arm (n = 152) of the ALEX study (data cut-off: 29 November 2019)
| n (%) | TEAEs |
TRAEs | |||||
|---|---|---|---|---|---|---|---|
| Any grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Any grade | |
| Any AEs | 147 (96.7) | 138 (90.8) | 112 (73.7) | 69 (45.4) | 14 (9.2) | 7 (4.6) | 123 (80.9) |
| Constipation | 56 (36.8) | 47 (30.9) | 8 (5.3) | 1 (0.7) | 0 | 0 | 42 (27.6) |
| Liver function abnormalities | 52 (34.2) | 16 (10.5) | 22 (14.5) | 12 (7.9) | 2 (1.3) | 0 | 45 (29.6) |
| Anaemia | 40 (26.3) | 12 (7.9) | 19 (12.5) | 8 (5.3) | 1 (0.7) | 0 | 24 (15.8) |
| Fatigue | 34 (22.4) | 28 (18.4) | 4 (2.6) | 2 (1.3) | 0 | 0 | 24 (15.8) |
| Peripheral oedema | 29 (19.1) | 25 (16.4) | 4 (2.6) | 0 | 0 | 0 | 16 (10.5) |
| Myalgia | 26 (17.1) | 21 (13.8) | 5 (3.3) | 0 | 0 | 0 | 17 (11.2) |
| Nausea | 25 (16.4) | 20 (13.2) | 4 (2.6) | 1 (0.7) | 0 | 0 | 12 (7.9) |
| Diarrhoea | 24 (15.8) | 18 (11.8) | 5 (3.3) | 1 (0.7) | 0 | 0 | 11 (7.2) |
| Upper respiratory tract infection | 21 (13.8) | 8 (5.3) | 12 (7.9) | 1 (0.7) | 0 | 0 | 0 |
| Rash | 21 (13.8) | 16 (10.5) | 2 (1.3) | 2 (1.3) | 1 (0.7) | 0 | 16 (10.5) |
| Arthralgia | 20 (13.2) | 16 (10.5) | 3 (2.0) | 1 (0.7) | 0 | 0 | 6 (3.9) |
| Back pain | 20 (13.2) | 12 (7.9) | 5 (3.3) | 3 (2.0) | 0 | 0 | 0 |
AE, adverse event; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.