Table 5 Safety (most frequent AEs related to REG clinical use) (FAS population, n = 654)
Adverse events | Any Grade N (%) | Grade 3–4 N (%) |
|---|---|---|
Any event | 524 (80.1) | 286 (43.7) |
Fatigue | 271 (41.4) | 95 (14.5) |
Hand and Food Skin Reactions | 189 (28.9) | 59 (9) |
Diarrhea | 123 (18.8) | 28 (4.3) |
Anorexia | 96 (14.7) | 19 (2.9) |
Hypertension | 72 (11) | 30 (4.6) |
Mucositis | 72 (11) | 8 (1.2) |
Weight loss | 33 (5) | 4 (<1) |
Rash or desquamation | 26 (4) | 8 (1.2) |
Thrombopenia | 21 (3.2) | 1 (<1) |
Muscle pain | 9 (1.4) | 1 (<1) |
Proteinuria | 8 (1.2) | 2 (<1) |
Hyperbilirubinemia | 7 (1.1) | 0 |