A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

Adverse Events by Severity, Seriousness, and Relationship to Treatment

Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.

Time frame: up to 12 months

Hematology Laboratory Abnormalities >/= Grade 3

Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

Time frame: up to 12 months

Chemistry Laboratory Abnormalities >/= Grade 3

Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

Time frame: up to 12 months

Area Under the Curve

Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin

Time frame: 3 weeks

Maximum Serum Concentration

Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

Time frame: 3 weeks

Time of Maximum Serum Concentration

Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

Time frame: 3 weeks