Table 5 Serious adverse events, comparison by groups among those with one or more SAEs

Number of SAEs within 1- month of enrollment (n)

24

13

0.17*

Median (Q1, Q3)

2.0 (1.0, 6.0)

1.0 (1.0, 4.0)

Number of SAEs within 3- months of enrollment (n)

29

17

0.18*

Median (Q1, Q3)

2.0 (1.0, 8.0)

1.0 (1.0, 7.0)

Number of SAEs within 12- months of enrollment (n)

34

24

0.16^*

Median (Q1, Q3)

2.0 (1.0, 13.0)

1.5 (1.0, 9.0)

SAEs: Serious adverse events

^*Wilcoxon rank sum p value.