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Table 5 Summary of safety data in the SELECT and DECISION trials

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

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)
  1. a ≥ 40% in any arm
  2. b ≥ 10% in any arm
  3. Source: Eisai Ltd. 2017 [24, 26, 27] and clinical study report for the DECISION trial (unpublished)