Table 1 Risks of clinical events over various treatment durations

Recurrent VTE and VTE-related death risks per cycle

 0–3 months

1.71%

1.2–2.2%

^a

 3–6 months

0.48%

0.22–0.75%

^a

 6–9 months

0.48%

0.01–1.1%

^b

 9–12 months

0.59%

0.07–1.1%

^b

 12–15 months

0.12%

0.00–0.35%

^b

 15–18 months

0.36%

0.00–0.76%

^b

Major bleed risk per cycle

^a

 0–3 months

0.41%

0.170.65%

^a

 3–6 months

0.15%

0.00–0.30%

^a

 Annual rate beyond 6 months

0.24%

0.00–0.57%

^b

CRNM bleed risk per cycle

^a

 0–3 months

2.65%

2.04–3.26%

^a

 3–6 months

1.20%

0.78–1.61%

^a

 Annual rate beyond 6 months

3.00%

1.82–4.12%

^b

Adverse event related discontinuation (not related to bleeding and VTE)

^a

 0–6 months

4.87%

4.05–5.68%

^a

 Annual rate beyond 6 months

6.67%

4.98–8.35%

^b

Distribution of recurrent VTE events

 VTE-related death–on treatment

21.54%

(28)

^a

 Recurrent PE–on treatment

37.69%

(49)

^a

 Recurrent DVT–on treatment

40.77%

(53)

^a

 VTE-related death–off treatment

11.88%

(12)

^b

 Recurrent PE–off treatment

24.75%

(25)

^b

 Recurrent DVT–off treatment

63.37%

(64)

^b

Distribution of major bleed events

 Fatal bleed–on treatment

13.46%

^a

 Non-fatal IC bleed–on treatment

13.97%

^a

 Non-fatal non-IC bleed–on treatment

86.03%

^a

 Fatal bleed–off treatment

13.46%

^b

 Non-fatal IC bleed–off treatment

13.97%

^b

 Non-fatal non-IC bleed–off treatment

86.03%

^b

Chronic thromboembolic pulmonary hypertension (patients with PE) (rate per 2.1 years)

1.25%

0.03–2.46%

[24]

Post-thrombotic syndrome (patients with DVT)

(% of patients experiencing per cycle)

8.10%

5.90–10.40%

[25]