Table 3.

Analysis of primary and secondary outcomes according to treatment exposure

	No. of patients	No. of outcomes	P-valuea	No. of patient days	Incidence rate per 100 patient days (95% CI)	CML estimate of rate ratio (95% CI)	P-valueb
Haemorrhagic complication
TA	66	17	<0.01	482	3.53 (2.05–5.65)	10.31 (3.67–35.70)	<0.01
No TA	71	4		1169	0.34 (0.09–0.88)
Thromboembolic complication
TA	66	1	0.06	482	0.21 (0.01–1.15)	0.35 (0.02–2.24)	0.34
No TA	71	7		1169	0.60 (0.24–1.23)
Composite endpoint
TA	66	18	0.09	482	3.73 (2.21–5.90)	3.97 (1.88–8.69)	<0.01
No TA	71	11		1169	0.94 (0.47–1.68)

Significant P-values are presented in bold. For definitions of haemorrhagic and thromboembolic complications please see Methods.

CI, confidence interval; CML, conditional maximum likelihood; No, number; No TA, i.e. either no antithrombotic medication received during hospital stay or administration of heparins [unfractionated heparin, low molecular weight heparins (LMWH)] in prophylactic dosing for prevention of venous thromboembolism (VTE); TA, i.e. either restarted therapeutic anticoagulation using VKA (scored on first day with INR levels ≥ 1.5), continuous or subcutaneous heparinization (targeting a therapeutic range of aPTT extended by 1.5–2.5) and or full weight adjusted dosing of LMWH (targeting 0.5–.0 anti-Xa units/mL).

^aCompared using the Pearson's χ² or the Fisher’s exact test as appropriate.

^bCompared using the Mid-P exact test.