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CELESTIAL Phase III study:
Grade 3 or 4 adverse events
Preferred Term, %
Cabozantinib
(N=467), %
Placebo
(N=237), %
Any grade 3 or 4 adverse event
68
37
Palmar-plantar erythrodysesthesia
17
0
Hypertension
16
2
AST increased
12
6
Fatigue
10
4
Diarrhoea
10
2
Asthenia
7
2
Decreased appetite
6
<1
ALT increased
5
2
Anaemia
4
5
Treatment-related grade 5 adverse events:
Cabozantinib (6 patients):
Hepatic failure, oesophagobronchial
fistula, portal vein thrombosis, upper gastrointestinal haemorrhage,
pulmonary embolism, hepatorenal syndrome
Placebo (1 patient):
Hepatic failure
CABOZANTINIB DATA
•
mDOT: 3.8 months.
•
Dose reductions: 62%
•
mDaily Dose: 35.8mg.
•
Discontinuation Rate due to Aes: 16%