Table 6 Summary of safety data in the observational studies and meta-analyses
Event | Lenvatinib TEAEs, range from studies | Sorafenib TEAEs, range from studies | Sorafenib TRAEs, range from studies | Sorafenib AEs | |
|---|---|---|---|---|---|
Median (95% CI) from meta-analysis by Thomas et al. 2014a | Median (95% CI) from meta-analysis by Shen et al. 2014 | ||||
Most common all-Grade AEs (%)b | |||||
 Hypertension | 76–90 [2] | 21–42 [3] | 43 [2] | 36 (27–46)[7] | 52 (33–72)[7] |
 Diarrhoea | 55–67 [2] | 52–77 [3] | 75–80 [2] | 70 (62–78)[7] | 68 (59–77)[7] |
 Decreased appetite | 52–78 [2] | 29 [1] | 20–82 [2] | – | – |
 Weight loss | 69 [1] | 29–58 [2] | 60–82 [2] | 57 (39–75)[7] | 52 (33–72)[7] |
 Nausea | 50 [1] | 10–27 [2] | 30–55 [2] | – | – |
 Fatigue | 60–73 [2] | 59 [1] | 63–66 [2] | – | – |
 Hand foot syndrome | 22–77 [2] | 71–79 [3] | 63–91 [2] | 74 (64–83)[7] | 80 (68–91)[7] |
 Rash | 24 [1] | 55–88 [2] | 79–85 [2] | 67 (52–82)[7] | 66 (50–82)[7] |
 Alopecia | 9 [1] | 52–74 [2] | 43–79 [2] | – | – |
 Proteinuria | 61–64 [2] | – | – | – | – |
 Stomatitis/ mucositis | 31–57 [2] | 27–48 [3] | 16–47 [2] | – | – |
 Cough | 45 [1] | – | – | – | – |
 Headache | 43 [1] | 15 [1] | 16 [1] | – | – |
 Dysphonia | 43 [1] | – | – | – | – |
 Infection | – | 68 [1] | – | – | – |
 Hypocalcaemia | – | 48 [1] | – | – | – |
 Dry skin | – | – | 84 [1] | – | – |
 Pruritis | – | – | 77 [1] | – | – |
 Flatulence | – | – | 70 [1] | – | – |
 Abdominal/ rectal pain | – | – | 68 [1] | – | – |
 Arthralgia | – | – | 61 [1] | – | – |
Most common Grade ≥ 3 AEs (%)c | |||||
 Hypertension | 10 [1] | 6–16 [2] | 4–13 [2] | 7 (3–12)[7] | – |
 Hand foot syndrome | 2 [1] | 23–44 [2] | 7 [2] | 19 (8–31)[7] | – |
 Weight loss | 12 [1] | 0–10 [2] | 5–10 [2] | 5 (1.2–9)[7] | – |
 Proteinuria | 10 [1] | – | – | – | – |
 Diarrhoea | 10 [1] | 3–7 [2] | 4–7 [2] | 7 (3–10)[7] | – |
 Fatigue | 9 [1] | 9 [2] | 16 [1] | 10 (4–16)[7] | – |
 Stomatitis/ mucositis | 2 [1] | 9–10 [2] | 0–2 | 4 (1–7)[7] | – |
 Rash | 0 [1] | 6–16 [2] | 4–18 [2] | 7 (3–11)[7] | – |
 Myocardial infarction | – | 10 [1] | – | – | – |
 Hand or foot pain | – | – | 12 [1] | – | – |
 Arthralgia | – | – | 11 [1] | – | – |
Treatment interruptions, reductions or discontinuations because of an adverse event (%) | |||||
 Dose interruptions | 74 [1] | 82 [1] | – | – | – |
 Dose reductions | 66 [1] | 42–100 [2] | 47–55 [2] | – | – |
 Discontinued treatment | 2–26 [2] | 23 [1] | 20 [1] | – | – |