Table 2.

Most common adverse events (all grades, ≥ 5% incidence) suspected to be related to sonidegib treatment

Once-daily doses, mgTwice-daily doses, mg
Total adverse events (%)1002004008001,0001,5003,000250400750All
Grade 3/4 (%)a(n = 6)(n = 6)(n = 5)(n = 26)(n = 11)(n = 9)(n = 10)(n = 14)(n = 8)(n = 8)(n = 103)
Gastrointestinal toxicity
 Nausea310434231526 (25.2)
 Dysgeusia110533563330 (29.1)
 Anorexia2118140453230 (29.1)1 (1.0)
 Vomiting110311121213 (12.6)
 Diarrhea00020011127 (6.8)
 Constipation01011010026 (5.8)
Muscle spasms220934054433 (32.0)
Myalgia0104312230217 (16.5)1 (1.0)
Blood creatine kinase increased1107242334332426533 (32.0)19 (18.4)
Increased transaminasesb0002022262211115 (14.6)6 (5.8)
Fatigue/asthenia520614131043128 (27.2)3 (2.9)
Alopecia110412112013 (12.6)
Lethargy00031011017 (6.8)
  • aItalicized numbers indicate grade 3/4 adverse events.

  • bIncludes increased alanine aminotransferase or aspartate aminotransferase.