Table 1.

Descriptive statistics of included patients

	Patients with ≥ 1 complete ADE reports (N = 2730)	Patients with ≥ 1 serious ADE reportsa (N = 1590)
Reports/patient, n (%)
1 report	2379 (87.1)	1417 (89.1)
2 reports	285 (10.4)	148 (9.3)
3 reports	46 (1.7)	15 (0.9)
4 reports	14 (0.5)	Suppressed
≥ 5 reports	6 (0.2)	Suppressed
Mean patient age (SD)	67.0 (19.5)	69.1 (18.5)
Median patient age [IQR]	71.0 [55.0, 82.0]	73.0 [59.0, 83.0]
Male sex, n (%)	1360 (49.8)	822 (51.7)

Cell sizes < 5 are suppressed

ADE adverse drug event, IQR interquartile range, SD standard deviation

^aSerious ADEs are those with an outcome of fetal defect, permanent disability, hospitalisation, extended hospitalisation, life threatening, or death