Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

PFS is the time from the date of randomization to the date of the first documented evidence of disease progression (based on the Revised Response Criteria for Malignant Lymphoma [Cheson 2014, Lugano Classification]) or death from any cause, whichever occurs first. Participants who initiated subsequent anticancer therapy or missed two or more consecutive overall disease assessments were censored as described in the SAP. Estimated by Kaplan-Meier method.

ORR is the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR) as determined by the investigator according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2014, Lugano Classification). ORR was assessed from the date of randomization through the date of first documented disease progression or initiation of subsequent anti-cancer therapy, whichever occurred first. Participants who did not have any post-baseline disease assessments or who initiated subsequent anti-cancer therapy prior to a documented response are considered non-responders.

Overall survival is defined as the interval between the date of randomization and the date of the participant's death from any cause. If a participant is not known to have died (this includes participants with unknown death date), OS will be censored at the date the participant was last known to have been alive. Estimated by Kaplan-Meier method.

The infusion-related reactions (IRR) rate is the proportion of subjects experiencing infusion related reactions that start on the day of a rituximab infusion and are assessed as related or possibly related to rituximab.

DOR is defined as the time from initial complete response (CR) or partial response (PR) to progressive disease (PD) or death due to any cause, whichever is first reported, regardless of discontinuation of study treatment. If such event did not occur, then participants were to be censored at the last adequate disease assessment as required for PFS censoring. Estimated by Kaplan-Meier method.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The treatment-emergent period is defined as the period from the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment or the day before initiation of subsequent anti-cancer therapy, whichever comes first. The treatment-emergent adverse events (TEAEs) are those events that occur or worsen during the treatment-emergent period or that are related to the study treatment.