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Table 1 Sample size calculation results

From: Simulating recurrent event data with hazard functions defined on a total time scale

 

Number of patientsN0

θ

d=2,p=0.2

d=8,p=0.5

0

160

184

0.1

204

226

0.2

252

274

0.3

296

320

0.4

340

366

0.5

380

422

  1. The simulation algorithm was applied to derive the number of individuals required for 80% power applying the robust two-sided Wald test at a 5% significance level for different frailty variances θ and risk-free intervals of length d (weeks) following an event with probability p. Each result was derived from 10000 simulation runs.