Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma

Number of Participants With Adverse Events (AEs)

Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. AE severity and seriousness are assessed independently. 'Severity' characterizes the intensity of an AE and is graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. An AE is considered 'serious' if it is life-threatening, fatal, requires hospitalization, or is otherwise considered to be medically significant.

Time frame: Up to 4 months

Number of Participants With Laboratory Abnormalities

Number of participants who experienced a maximum post-baseline laboratory toxicity of Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03).

Time frame: Up to 4 months

Objective Response Rate (ORR)

ORR is defined as the proportion of patients with complete remission (CR) or partial remission (PR) per independent review facility (IRF) at the end of treatment.

Time frame: Up to 4 months

Duration of Complete Response (CR)

Defined as the time from the start of the first radiographic documentation of CR per investigator to the first documentation of progressive disease, death due to any cause, or receipt of subsequent anticancer therapy, whichever comes first.

Time frame: Up to 27.9 months

Duration of Objective Response (OR)

Duration of OR is defined as the time from the start of the first radiographic documentation of OR per investigator to the first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy, whichever comes first.

Time frame: Up to 27.9 months

Progression-free Survival (PFS)

PFS is defined as the time from randomization to first documentation of disease progression per investigator, death due to any cause, or receipt of subsequent anticancer therapy, whichever comes first.

Time frame: Up to 30 months

Overall Survival (OS)

OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the patient is known to be alive.

Time frame: Up to 30 months

Number of Patients Achieving Peripheral Blood Stem Cell (PBSC) Mobilization

Defined as the number of patients who are able to adequately mobilize PBSC per investigator assessment on or after completion of study treatment, prior to subsequent anticancer therapy.

Time frame: Up to 30 months

Number of Patients Receiving Autologous Stem Cell Transplant (ASCT)

Number of patients receiving ASCT after completion of study treatment (EOT), prior to subsequent anticancer therapy.

Time frame: Up to 30 months