Table 3.
Summary of specific AEs in patients in the alectinib arm (n = 152) of the ALEX study (data cut-off: 29 November 2019)
| AE | Patients, n (%) | Events, n | Median time to onset, (IQR) | Number resolved, n (%) | Median time to resolution, (IQR) |
|---|---|---|---|---|---|
| Constipation | 56 (36.8) | 72 | 0.8 (0.3-1.7) | 46 (63.9) | 5.2 (1.4-NE) |
| Liver function abnormalities | 52 (34.2) | 139 | 1.8 (1.0-5.6) | 114 (82.0) | 2.4 (1.0-11.3) |
| Anaemia | 40 (26.3) | 51 | 3.9 (1.8-18.6) | 32 (62.7) | 6.7 (1.0-NE) |
| Fatigue | 34 (22.4) | 42 | 1.0 (0.4-7.4) | 25 (59.5) | 4.1 (1.5-NE) |
| Peripheral oedema | 29 (19.1) | 36 | 2.3 (0.7-9.5) | 26 (72.2) | 12.9 (1.1-37.7) |
| Myalgia | 26 (17.1) | 29 | 1.1 (0.3-7.8) | 19 (65.5) | 8.1 (2.1-39.3) |
| Rash | 21 (13.8) | 34 | 6.1 (0.5-12.1) | 31 (91.2) | 1.9 (0.4-4.0) |
| Bradycardia | 13 (8.6) | 13 | 1.0 (1.0-11.1) | 5 (38.5) | NE (4.6-NE) |
| Renal toxicity | 4 (2.6) | 4 | 3.4 (1.7-4.1) | 3 (75.0) | 0.4 (0.2-1.1) |
AE, adverse event; IQR, interquartile range; NE, not estimable.