Table 2.

Risk of serious ADR, death and thromboembolic events

	Risk of serious ADR Adjusted ROR (95% CI)			Risk of death Adjusted ROR (95% CI)			Risk of thromboembolic ADR Adjusted ROR (95% CI)
	Overall	Idarucizumab	Andexanet alfa	Overall	Idarucizumab	Andexanet alpha	Overall	Idarucizumab	Andexanet alpha
Overall
Sex
Males	1	1	1	1	1	1	1	1	1
Females	0.92 (0.54–1.55)	0.98 (0.55–1.72)	0.80 (0.17–3.84)	1.00 (0.76–1.31)	1.03 (0.76–1.40)	1.01 (0.48–2.10)	1.17 (0.83–1.65)	1.15 (0.75–1.75)	1.07 (0.51–2.23)
Age
Adult (18–65 years)	1	1	1	1	1	1	1	1	1
Youngest-old (65–74 years)	0.93 (0.26–3.30)	0.72 (0.18–2.89)	-	0.80 (0.47–1.34)	1.06 (0.60–1.89)	0.21 (0.06–0.77)	0.69 (0.39–1.23)	0.62 (0.30–1.28)	1.01 (0.30–3.42)
Middle-old (75–84 years)	0.67 (0.22–2.05)	0.55 (0.16–1.93)	0.40 (0.03–4.52)	0.93 (0.58–1.49)	1.10 (0.65–1.85)	0.33 (0.10–1.07)	0.55 (0.32–0.94)	0.55 (0.29–1.05)	0.76 (0.24–2.39)
Oldest-old (≥ 85 years)	0.53 (0.17–1.65)	0.51 (0.14–1.89)	0.13 (0.02–1.46)	1.13 (0.68–1.89)	1.27 (0.72–2.25)	0.60 (0.17–2.09)	0.50 (0.28–0.90)	0.54 (0.26–1.11)	0.39 (0.11–1.32)
Number of suspected/interacting medications
1	1	1	1	1	1	1	1	1	1
2–4	1.36 (0.79–2.32)	1.07 (0.52–2.20)	1.04 (0.42–2.56)	0.91 (0.68–1.20)	0.63 (0.44–0.92)	1.74 (1.06–2.86)	1.30 (0.92–1.82)	1.26 (0.76–2.09)	0.67 (0.39–1.15)
≥ 5	-	-	-	0.34 (0.11-1.00)	0.77 (0.17–3.50)	0.21 (0.02–1.82)	2.10 (0.70–6.29)	1.09 (0.13–9.29)	0.72 (0.16–3.28)
Number of concomitant medications
0	1	1	1	1	1	1	1	1	1
1–4	2.51 (1.38–4.57)	1.27 (0.59–2.70)	5.66 (2.11–15.24)	1.91 (1.40–2.60)	1.15 (0.76–1.71)	4.80 (2.77–8.34)	0.94 (0.65–1.38)	0.99 (0.57–1.72)	0.62 (0.35–1.11)
≥ 5	6.35 (2.28–17.68)	4.04 (1.43–11.44)	-	1.70 (1.22–2.36)	1.66 (1.13–2.44)	1.89 (0.93–3.86)	1.05 (0.71–1.56)	0.84 (0.49–1.44)	1.71 (0.82–3.57)

CI: confidence interval; ROR: Reporting Odds Ratio

Analysis was adjusted for age, sex, number of suspected/interacting drugs, and number of concomitant medications