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%] |