Table 2.

Overview of adverse events

	Number of adverse events	Number of episodes	Incidence
Any adverse event	2545	1978	13.0% [12.5%; 13.6%]
Serious adverse events	105	100	0.7% [0.5%; 0.8%]
Severe adverse events	154	126	0.8% [0.7%; 1.0%]
Adverse events of special interest	3	3	<0.1%
Fatal serious adverse events	24	22	0.2% [0.1%; 0.2%]
Potentially ASAQ-related adverse events	929	837	5.5% [5.2%; 5.9%]
Adverse events requiring corrective treatment	157	105	0.7% [0.6%; 0.8%]