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Table 6 Summary of safety data in the observational studies and meta-analyses

From: A systematic review of lenvatinib and sorafenib for treating progressive, locally advanced or metastatic, differentiated thyroid cancer after treatment with radioactive iodine

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]
  1. - = not reported or not applicable; AE Adverse event, C Confidence interval, TEAE treatment-emergent adverse event; TRAE Treatment-related adverse event
  2. aOne of the included studies did not include only patients with RR-DTC
  3. b ≥ 40% in any study
  4. c ≥ 10% in any study
  5. [x] denotes the number of studies from which data are derived