Table 4.

Most frequent drug‐related grade ≥3 TEAEs during the combination treatment phase (≥2 patients; safety analysis set, n = 42)

Drug‐related TEAE (by MedDRA), n (%)	Regorafenib (n = 42)	Cetuximab (n = 42)
Hypophosphatemia	10 (24)	3 (7)
Fatigue	4 (10)	2 (5)
Lipase increased	4 (10)	1 (2)
AST increase	2 (5)	1 (2)
Gamma‐glutamyltransferase increased	2 (5)	2 (5)
Hypertension	2 (5)	2 (5)
Hypotension	2 (5)	1 (2)
Decreased appetite	2 (5)	1 (2)
Nausea	2 (5)	1 (2)
Diarrhea	1 (2)	2 (5)

The following AEs are counted in both arms: skin reactions (rash, hand–foot skin reaction, Stevens–Johnson syndrome), hepatobiliary disorders (increase in liver enzyme), metabolism and nutrition disorders (hypomagnesemia, hypocalcemia, anorexia/weight decrease), nervous system disorders (headache), gastrointestinal disorders (diarrhea, nausea, vomiting) and general disorders (mucositis, fatigue).

Abbreviations: AE, adverse event; AST, aspartate aminotransferase; MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment‐emergent adverse event.