Table 2.
Frequent AEs (>50%) | All grades (%) | G3 (%) | Common AEs (50-10%) | All grades (%) | G3 (%) | Not common AEs (<10%) | All grades (%) | G3 (%) |
---|---|---|---|---|---|---|---|---|
Cardiovascular | ||||||||
hypertension | 33–53 | 8.4–20 | pulmonary embolism | 3.3 | 0 | |||
Dermatological | ||||||||
palmar-plantar erythrodyesthesia | 40–53 | 13–12 | rash | 19.2–23 | 0.9 | |||
mucositis | 20–53 | 0–3.3 | dry skin | 19.2–20.1 | 0–2.8 | |||
Gastrointestinal | ||||||||
diarrhoea | 52–87 | 7.3–21 | dysgeusia | 26–45 | 0.1–0.5 | |||
decreased appetite | 49–80 | 7–13 | constipation | 26–34 | 0-1 | |||
nausea | 43–80 | 0–6.9 | stomatitis | 19–30 | 1.4–2.6 | |||
vomiting | 24–60 | 2.3–7 | ||||||
Constitutional | ||||||||
fatigue | 41–80 | 7–13 | arthralgia | 14 | 2.3 | |||
weight decrease | 35–73 | 3.4–13 | myalgia | 7–27 | 1 | |||
insomnia | 10.7 | 0 | ||||||
pruritus | 13.6 | 0.5 | ||||||
headache | 13–18.2 | 0.4–0.5 | ||||||
alopecia | 16.4 | 0 | ||||||
hair colour changes | 33–34 | 0.5 | ||||||
Renal | ||||||||
proteinuria | 47 | 7 | ||||||
Lab alteration | ||||||||
incresed AST | 10–100 | 7–3.2 | hypophosphatemia | 20 | 13 | increased ALP | 3 | 0 |
increased ALT | 24–73 | 7-5 | hyponatremia | 13–33 | 7–27 | |||
increased LDH | 73 | 7 | ||||||
hypocalcemia | 23–60 | 13-0 | ||||||
hypokalemia | 47 | 13-3.8 | ||||||
Haematologic | ||||||||
anaemia | 20–31 | 7 | ||||||
leukopenia | 27 | 7 | ||||||
Respiratory tract | ||||||||
pneumonia | 4.2–13 | 13 | ||||||
dyspnoea | 13.6–21 | 2.3–3.5 | ||||||
dysphonia | 21–27 | 0–10.1 | ||||||
Thyroid | ||||||||
thyroid disfunction | 14 | 0 |
AE Adverse Event, AST Aspartate Aminotransferase, ALT Alanine Aminotransferase, LDH Lactate Dehydrogenase, ALP Alkaline Phosphatase