Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients

PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by \> 50% of previously involved sites from nadir.

Time frame: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm

Population: Modified Intent-to-treat (mITT) Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.

PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by \> 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years.

Time frame: 2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm)

Population: Modified Intent-to-treat (mITT) Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.

Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease.

Time frame: End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]

Population: Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.

Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by \> 50% of previously involved sites from nadir.

Time frame: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm

Population: Participants from the Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment who had a CR or PR

FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point.

Time frame: End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment]

Population: Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.

ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites.

Time frame: End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]

Population: Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.

Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact.

Time frame: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm

Population: MITT Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.

Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE.

Time frame: Days 1, 4 and 10 of each cycle and end of treatment visit (Median of 16 weeks on treatment)

Population: Safety Population included all randomized participants who received at least 1 dose of study drug.

Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

Time frame: First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks)

Population: Safety Population included all randomized participants who received at least 1 dose of study drug.

TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by \> 50% of previously involved sites from nadir.

Time frame: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm

Population: MITT Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.