Statistical analyses
The FAS was used for all efficacy endpoints (except endpoints based on assessment by IRC), safety, PK, and baseline analysis. The PPS was used for endpoints based on assessment by IRC and used as appropriate for investigator assessment endpoints. The estimate and 95% confidence interval (CI) for the CR rate, ORR, and uMRD rate were based on exact binomial distribution. The CR rate was compared to a historical control threshold of 12.5% observed with ibrutinib monotherapy in Japanese patients with R/R MCL using the exact binomial test at a 1-sided overall significance level of 0.025 [