Table 4.

Safety information by treatment arm

Treatment	AL, n = 193	ASAQ, n = 188	P-value
Total number of adverse events (AE)	386	346	–
Mean AEs per patient	2	1.8	0.20
Severity of adverse events (%)
Mild	83.4	84.7	0.642
Moderate	13.7	13.9	0.956
Serious	2.9	1.4	0.382
Relationship of events with the treatment (%)
Definitely unrelated	29.5	30.3	0.810
Unlikely	54.2	55.2	0.774
Possible	12.7	10.7	0.401
Probable	3.6	3.8	0.926
Definitely related	0	0	–