Table 3.

Adverse events, regardless of treatment attribution, occurring in >20% of patients

ENC + CTX, n = 26ENC + ALP + CTX, n = 28
Adverse event, n (%)All gradesGrade 3/4All gradesGrade 3/4
Fatigue13 (50.0)3 (11.5)12 (42.9)1 (3.6)
Vomiting12 (46.2)2 (7.7)14 (50.0)0
Dyspnea9 (34.6)1 (3.8)5 (17.9)3 (10.7)
Abdominal pain8 (30.8)3 (11.5)7 (25.0)1 (3.6)
Nausea8 (30.8)017 (60.7)1 (3.6)
Hyperglycemia2 (7.7)011 (39.3)3 (10.7)
Back pain7 (26.9)1 (3.8)3 (10.7)1 (3.6)
Constipation7 (26.9)1 (3.8)4 (14.3)0
Decreased appetite7 (26.9)08 (28.6)1 (3.6)
Hypophosphatemia7 (26.9)5 (19.2)4 (14.3)1 (3.6)
Infusion-related reaction7 (26.9)01 (3.6)0
Weight decreased7 (26.9)010 (35.7)1 (3.6)
Dysphonia2 (7.7)07 (25.0)0
Melanocytic nevus1 (3.8)07 (25.0)0
Peripheral edema2 (7.7)07 (25.0)0
Cough6 (23.1)02 (7.1)1 (3.6)
Headache6 (23.1)04 (14.3)0
Myalgia6 (23.1)04 (14.3)0
Pain in extremity6 (23.1)02 (7.1)0
Stomatitis6 (23.1)04 (14.3)1 (3.6)
Dysgeusia1 (3.8)06 (21.4)0
Diarrhea5 (19.2)1 (3.8)15 (53.6)1 (3.6)
Dry skin5 (19.2)09 (32.1)0
Rash5 (19.2)010 (35.7)0
Hypomagnesemia4 (15.4)08 (28.6)1 (3.6)
Dermatitis acneiform3 (11.5)08 (28.6)1 (3.6)
Pyrexia3 (11.5)08 (28.6)1 (3.6)
  • NOTE: All patients had at least 1 adverse event.

  • Abbreviations: ENC + ALP + CTX, encorafenib combined with alpelisib and cetuximab; ENC + CTX, encorafenib combined with cetuximab.