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Table 4 Most common TEAEs according to duration of exposure to vismodegib

From: Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study

TEAE Occurring in >20% of Patients, n (%)a Exposure <12 Months (n = 48) Exposure ≥12 Months (n = 56)
  Any Grade Grade
≥ 3b
Any Grade Grade
≥ 3b
Any AE 48 (100.0) 27 (56.3) 56 (100.0) 31 (55.4)
Muscle spasms 25 (52.1) 2 (4.2) 49 (87.5) 4 (7.1)
Alopecia 24 (50.0) NA 45 (80.4) NA
Dysgeusia 20 (41.7) NA 38 (67.9) NA
Weight decreased 18 (37.5) 0 36 (64.3) 9 (16.1)
Fatigue 17 (35.4) 4 (8.3) 28 (50.0) 1 (1.8)
Nausea 11 (22.9) 0 23 (41.1) 0
Decreased appetite 15 (31.3) 2 (4.2) 14 (25.0) 1 (1.8)
Diarrhea 10 (20.8) 0 18 (32.1) 3 (5.4)
Constipation 10 (20.8) 0 10 (17.9) 0
Cough 8 (16.7) 0 12 (21.4) 0
Arthralgia 5 (10.4) 0 12 (21.4) 1 (1.8)
  1. AE adverse event, NA not applicable, TEAE treatment-emergent adverse event
  2. aMedical Dictionary for Regulatory Activities–preferred term
  3. bNCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0