Table 3.

Overall summary of number of patients with adverse events in the combined patient population

	Treatment group
	Ilofotase alfa (N = 330) n (%)	Placebo (N = 320) n (%)	p value*
Adverse events	224 (67.9%)	240 (75%)	0.0446
Serious adverse events	143 (43.3%)	141 (44.1%)	0.8514
Fatal adverse events	99 (30%)	98 (30.6%)
Serious non-fatal adverse events	64 (19.4%)	62 (19.4%)
Drug-related adverse events	30 (9.1%)	32 (10%)
Serious drug-related adverse events	16 (4.8%)	16 (5%)
Adverse events leading to withdrawal of trial drug	9 (2.7%)	6 (1.9%)
Serious adverse events leading to withdrawal of trial drug	8 (2.4%)	5 (1.6%)
Adverse events by severity**
Mild	29 (8.8%)	31 (9.7%)

Patients have been analyzed according to treatment received

*Nominal p value based on Chi-square test

**The AEs are differentiated from Mild to Severe