Patients were observed from the start of brentuximab vedotin treatment through 16 cycles or until treatment discontinuation. The follow-up period of up to 16 cycles was defined based on a previous clinical study investigating the safety of brentuximab vedotin beyond 16 cycles (NCT00947856). The following details were recorded regarding each patient’s treatment: use of premedication for infusion reactions, receipt of hematopoietic stem cell transplantation (HSCT) after brentuximab vedotin treatment, antitumor treatment for HL or sALCL other than brentuximab vedotin and use of prophylactic agents against infection.

Throughout the observation period, AEs were monitored and recorded by the investigating physicians until the final assessment. After the final assessment, recorded AEs were coded using the Medical Dictionary for Regulatory Activities Japanese language version (MedDRA/J, version 19.1) and graded according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). Progression of the primary disease was not considered as an AE, unless the disease worsened abnormally and was described by the investigating physician as an AE. AEs for which a causal relationship to brentuximab vedotin was at least a reasonable possibility (i.e., the relationship could not be ruled out) as deemed by the investigating physician were defined as adverse drug reactions (ADRs). ADRs of special interest (ADRSIs) for this study were peripheral neuropathy (including sensory and motor), infections, neutropenia, infusion reactions, and pulmonary toxicity. The definitions of each of the ADRSIs were established using System Organ Class or Preferred Terms within MedDRA/J.

Patients were assessed for antitumor activity during treatment per routine clinical practice at the study sites, including the use of positron emission tomography (PET). Using these assessments, best response was determined according to the Revised Response Criteria for Malignant Lymphoma [10]. Survival status was confirmed for each patient at the time of their final observation date; for patients who died, the date of death was recorded.

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