Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Objective Response Rate (ORR) |
Objective response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites. |
Baseline until disease progression, death or end of study (EOS) (Up to 24 months) |
|
Secondary |
Duration of Response (DOR) |
DOR is defined as the time in months from the date of first documentation of a CR or PR response to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. |
From first documented complete or partial remission until disease progression (Up to 24 months) |
|
Secondary |
Progression Free Survival (PFS) |
PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first. |
Baseline until disease progression, death or end of treatment (EOT), and then every 3 months up to approximately 6 years |
|
Secondary |
Complete Remission Rate |
Complete remission rate is defined as percentage of participants with CR per IRF response assessment based on IWG criteria are reported. CR is defined as the disappearance of all evidence of disease. |
Baseline until disease progression, death or EOS (Up to approximately 6 years) |
|
Secondary |
Duration of Complete Remission |
Duration of CR is defined as the time from the date of first documentation of a CR or to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. |
From first documented complete remission until disease progression (up to approximately 6 years) |
|
Secondary |
Overall Survival (OS) |
OS is the time in months from start of study treatment to date of death due to any cause. |
Every 3 months for 18 months after EOT, thereafter, every 6 months until the sooner of death, study closure, or 5 years after enrollment of the last participant (up to approximately 6 years) |
|
Secondary |
Percentage of Participants Who Received Hematopoietic SCT |
|
Baseline up to EOS (up to approximately 6 years) |
|
Secondary |
Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs |
An 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 SAE a serious 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. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. AEs Grade 3 and higher are severe. |
From first dose through 30 days after the last dose of study medication (Up to 24 months) |
|
Secondary |
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs |
Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention. |
From the first dose through 30 days after the last dose of study medication (Up to 24 months) |
|
Secondary |
Antibody-drug Conjugate (ADC) Serum Concentrations |
Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate. |
Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months) |
|
Secondary |
Serum Concentration of Total Antibodies (Conjugated and Unconjugated) |
Blood samples were collected and tested for conjugated and unconjugated antibodies. |
Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months) |
|
Secondary |
Monomethyl Auristatin E (MMAE) Serum Concentrations |
Blood samples were collected and tested for MMAE serum concentrations. |
Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months) |
|
Secondary |
Number of Participants With Antitherapeutic Antibodies (ATA) |
Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-Baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-Baseline confirmed ATA positive responses) and neutralizing ATA (nATA) status. The confirmed ATA-positive samples were assessed for ATA titer and delineated into having high or low titers. |
Day 1 of every 3-week cycle up to 16 cycles and EOT (Up to 24 months) |
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