PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

Overall Disease-Free Survival (DFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease) or death from any cause. DFS was assessed according to International Working Group recommendations. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.

Time frame: Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months)

Population: All randomized participants. DFS is censored at the last assessable disease free assessment for participants who are alive or have not progressed. The number of censored participant data for enzastaurin and placebo is 369 (73.2%) and 180 (70.9%), respectively.

The EQ-5D instrument is a participant-rated questionnaire used to evaluate health status. The EQ-5D assesses five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) that participants rate using three levels (no problem, some problem, or extreme problem), as well as overall health status. The five dimensions can be combined using country-specific weights to create an estimate of overall health status score. The possible values for score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline in the EQ-5D for the United Kingdom population-based index score adjusting for baseline covariates.

Time frame: Baseline, Month 6; Baseline, Month 24; Baseline, Month 33

Population: All randomized participants who completed at least one EQ-5D assessment.

Disease-free survival at 2 years (DFS2) is defined as the rate of DFS at 2 years from the date of study enrollment and is determined using the distribution of overall DFS times. Disease-free survival rates at 2 years will be estimated using the Kaplan-Meier method.

Time frame: Baseline to 2 Years

Population: All randomized participants.

Overall Event-Free Survival (EFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease), institution of a new anti-cancer treatment, or death from any cause. Progressive disease (PD) is defined as a ≥ 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.

Time frame: Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months)

Population: All randomized participants. EFS is censored at the last assessable disease-free assessment for participants who are alive, have not progressed or started new anticancer treatment. The number of censored participant data for enzastaurin and placebo is 364 (72.2%) and 176 (69.3%), respectively.

Event-Free Survival at 2 years (EFS2) is defined as the rate of EFS at 2 years from the date of study enrollment and is determined using the distribution of overall EFS times. Event-free survival rates at 2 years will be estimated using the Kaplan-Meier method.

Time frame: Baseline to 2 Years

Population: All randomized participants.

Number of participants with treatment-emergent adverse events.

Time frame: First dose through 30 days post-study treatment discontinuation (up to 81.30 months)

Population: All randomized participants who received at least one dose of study drug.

Overall survival (OS) time is defined as the time from the date of study enrollment to the date of death from any cause.

Time frame: Baseline to Date of Death from Any Cause (up to 80.30 months)

Population: All randomized participants. Overall survival is censored at the last date of contact for participants who have no reported death. The number of censored participant data for enzastaurin and placebo is 404 (80.2%) and 205 (80.7%), respectively.

Time frame: Month 2, Month 4: Predose

Population: All participants who received at least one dose of the study drug and had evaluable PK data.

The FACT-Lym assesses health-related quality of life (HRQoL) in participants with non-Hodgkin lymphoma. It includes the 27-item cancer-specific FACT-G (General), which assesses physical, social/family, emotional and functional well-being, plus a 15-item subscale that assesses concerns specific to lymphoma. Each item is scored on a scale from 0 (not at all) to 4 (very much), yielding a possible score of 0-168, with higher scores representing better HRQoL. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline adjusting for baseline covariates.

Time frame: Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36

Population: All randomized participants who completed at least one FACT-Lym assessment.

Reported are the DFS based on PKC-β2 protein expression. Immunohistochemistry (IHC) staining was performed to assess protein expression of PKC-β2 in cytoplasm scored for percent of tumor cells stained, and using 50% positive staining as the cutoff for high/low expression (high expression: \>=50% staining, low expression: \<50% staining).

Time frame: Baseline to 94.5 months

Population: All randomized participants for which a pre-treatment tumor tissue was provided and had evaluable samples.

Reported are the DFS for GCB and non-GCB status. DLBCL molecular subtypes of GCB/non-GCB using Hans' algorithm were determined by protein expression by immunohistochemistry (IHC) staining was used to assess molecular subtype characterization of GCB and non-GCB.

Time frame: Baseline to 24 months (2 years)

Population: All randomized participants for which a pre-treatment tumor tissue was provided and had evaluable samples.