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. 2021 Oct 7;126(4):569–575. doi: 10.1038/s41416-021-01532-5

Table 4.

All-causality grade 3 or 4 adverse events by ALBI grade (safety population)a.

ALBI grade 1 ALBI grade 2
Cabozantinib (N = 186) Placebo (N = 102) Cabozantinib (N = 279) Placebo (N = 133)
Any grade 3 or 4 adverse event, n (%) 140 (75) 35 (34) 176 (63) 50 (38)
 Hypertension 40 (22) 3 (3) 34 (12) 1 (1)
 PPE 33 (18) 0 46 (16) 0
 Diarrhea 25 (13) 1 (1) 21 (8) 3 (2)
 AST increased 15 (8) 4 (4) 40 (14) 11 (8)
 Fatigue 14 (8) 2 (2) 35 (13) 8 (6)
 Decreased appetite 9 (5) 0 18 (6) 1 (1)
 Asthenia 8 (4) 2 (2) 24 (9) 2 (2)
 Anemia 5 (3) 1 (1) 14 (5) 11 (8)

ALBI albumin–bilirubin, AST aspartate aminotransferase, PPE palmar-plantar erythrodysesthesia.

aEvents that occurred at ≥5.0% frequency in either treatment arm in the overall safety population are summarised.