The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.

Efficacy analyses were performed on all 144 treated subjects. The primary analysis (PA) used IRC assessment of efficacy endpoints. In the PA, there were no differences between the IRC and investigator responses. IRC assessment was no longer performed after the PA and the final analysis result report investigator-assessed efficacy outcomes.

Number of participants who had experienced at least one treatment emergent AE

Participants who received at least 1 dose of PCI-32765 and constitute the all treated population.