Table 2.

Primary outcome measure: Treatment-emergent adverse events in patients with primary hyperoxaluria type 1 during the placebo comparison period (days 1–85)

Adverse Events, n (%)	Placebo, n=3	Lumasiran
		1 mg/kg Once Monthly, n=7	3 mg/kg Once Monthly, n=7	3 mg/kg Once Every 3 mo, n=3	All Lumasiran, n=17
Any adverse event	2 (67)	5 (71)	4 (57)	1 (33)	10 (59)
Serious adverse eventa	1 (33)	0 (0)	2 (29)	0 (0)	2 (12)
Severe adverse eventb	1 (33)	0 (0)	0 (0)	0 (0)	0 (0)
Adverse event leading to treatment discontinuation	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Death	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Injection site reactionsc	0 (0)	1 (14)	1 (14)	0 (0)	2 (12)

n, number of patients.

^aPatient treated with placebo: nephrolithiasis and pyelonephritis acute. Patients treated with lumasiran: vomiting and nephrolithiasis.

^bPyelonephritis acute.

^cIncludes all adverse events mapping to the Medical Dictionary for Regulatory Activities high-level term injection site reactions.