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. 2019 Jun 14;145(9):2450–2458. doi: 10.1002/ijc.32317

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.