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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