Observational Study: Safety and Effectiveness of Obinutuzumab in Chronic Lymphocytic Leukemia in Argentina

Overall response rate was defined as percentage of participants with complete response (CR) or partial response (PR). CR was defined as peripheral blood lymphocytes below 4 x 10^9/liter (L), absence of significant lymphadenopathy, no hepatomegaly, no splenomegaly, absence of disease or B symptoms, neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin >11 grams/deciliter (g/dl) and bone marrow at least normocellular for age. PR was defined as >=50% decrease in peripheral blood lymphocyte count, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver enlargement and/or >/=50% reduction of spleen enlargement, plus at least one of the following: neutrophils >1.5 x 10^9/L or >/=50% increase, or platelets >100 x 10^9/L or ≥50% increase, or hemoglobin 11 g/dl or >/=50% increase. Overall response rate = CR + PR

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

CR was defined as peripheral blood lymphocytes below 4 x 10^9/liter (L), absence of significant lymphadenopathy, no hepatomegaly, no splenomegaly, absence of disease or B symptoms, neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin 11 g/dl and bone marrow at least normocellular for age.

PR was defined as >=50% decrease in peripheral blood lymphocyte count from the pre-treatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver enlargement and/or >/=50% reduction of spleen enlargement, plus at least one of the following: neutrophils >1.5 x 10^9/L or >/=50% increase, or platelets >100 x 10^9/L or ≥50% increase, or hemoglobin 11 g/dl or >/=50% increase.

PFS is defined as the time from the first dose of treatment to the first occurrence of progression, or death from any cause as assessed by the physician. Progressive disease is defined by any of the following: >/=50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, >/=50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, >/=50% increase in the enlargement of the liver and/or spleen, transformation to a more aggressive histology, after treatment, the progression of any cytopenia (a decrease of hemoglobin levels >2 g/dL or <10 g/dL or a decrease of platelet counts >50% or <100 x 10x9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L), excluding immune causes.

Duration of response is defined as the time from the date the response (either CR or PR) was first recorded until the date of disease progression or death due to any cause. Disease progression is defined by any of the following: >/=50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, >/=50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, >/=50% increase in the enlargement of the liver and/or spleen, transformation to a more aggressive histology, after treatment, the progression of any cytopenia (a decrease of hemoglobin levels >2 g/dL or <10 g/dL or a decrease of platelet counts >50% or <100 x 10x9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L), excluding immune causes.