Table 2.

Sample size calculations

	Assumed rate of AE leading to, or prolonging, hospitalization	Assumed absolute precision (relative precision)	Sample size (without drop-outs)	Sample size (including drop-outs)
DVT	0.123	0.031 (± 25%)	432	540
PE	0.179	0.045 (± 25%)	279	349

Sample size (for each region) for the assumed rate of AEs leading to, or prolonging hospitalization 0.123 (DVT) and 0.179 (PE) in order to achieve an absolute precision of 0.031 (DVT) and 0.045 (PE) for a two-sided 95% CI. (Based on normal approximation, calculated by nQuery Advisor^® 7.0.). AE, adverse event