Table 5 Summary of safety data in the SELECT and DECISION trials
Outcome, n (%) | SELECT trial | DECISION trial | ||
|---|---|---|---|---|
Lenvatinib N = 261 | Placebo N = 131 | Sorafenib N = 207 | Placebo N = 209 | |
Any adverse event | 260 (99.6) | 118 (90.1) | 204 (98.6) | 183 (87.6) |
Any Grade ≥ 3 adverse event | 223 (85.4) | 39 (29.8) | 133 (64.3) | 63 (30.1) |
Most common all-Grade AEsa | ||||
 Hypertension | 181 (69.3) | 19 (14.5) | 84 (40.6) | 26 (12.4) |
 Diarrhoea | 173 (66.3) | 22 (16.8) | 142 (68.6) | 32 (15.3) |
 Decreased appetite / anorexia | 139 (53.3) | 24 (18.3) | 66 (31.9) | 10 (4.8) |
 Weight loss | 132 (50.6) | 19 (14.5) | 97 (46.9) | 29 (13.9) |
 Nausea | 121 (46.4) | 33 (25.2) | 43 (20.8) | 24 (11.5) |
 Fatigue | 110 (42.1) | 32 (24.4) | 103 (49.8) | 53 (25.4) |
 Hand-foot syndrome | 84 (32.2) | 1 (0.8) | 158 (76.3) | 20 (9.6) |
 Rash or desquamation | 48 (18.4) | 2 (1.5) | 104 (50.2) | 24 (11.5) |
 Alopecia | 32 (12.3) | 7 (5.3) | 139 (67.1) | 16 (7.7) |
Most common Grade ≥ 3 AEsb | ||||
 Hypertension | 112 (42.9) | 5 (3.8) | 20 (9.7) | 5 (2.4) |
 Hand-foot syndrome | 9 (3.4) | 0 | 42 (20.3) | 0 |
 Weight loss | 31 (11.9) | 1 (0.8) | 12 (5.8) | 2 (1) |
 Proteinuria | 26 (10) | 0 | 0 | 0 |
Treatment interruptions, reductions or discontinuations because of an adverse event | ||||
 Dose interruptions | 215 (82.4) | 24 (18.3) | 137 (66.2) | 54 (25.8) |
 Dose reductions | 177 (67.8) | 6 (4.6) | 133 (64.3) | 19 (9.1) |
 Discontinued treatment | 43 (16.5) | 6 (4.6) | 39 (18.8) | 8 (3.8) |