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.