Table 3.

Comparison of safety outcomes of givinostat

Parameter	Intervention group	Control group	Safety impact of givinostat
DMD (EPIDYS) (Mercuri et al. [35], 2024)
Most common AE	Diarrhoea (36%)	Nasopharyngitis (31%)	Different AE profiles
Treatment interruption	16 (14%)	4 (7%)	2-fold higher interruption rate
Treatment discontinuation	4 (3%)	Not reported	Slightly higher discontinuations
Severe AEs	5 (4%)	1 (2%)	Higher severe AE rate
BMD (Comi et al. [30], 2023)
Most common AE	Decreased platelet count (58.82%)	Hypertriglyceridemia (11.76%)	Higher rate of haematologic AEs
Treatment interruption	11 (32.35%)	1 (5.88%)	Significantly higher interruption rate
Severe AEs	5 (14.7%)	0 (0%)	Notable increase in severe AEs

AE, adverse event.