An Observational Study of the Safety and Effectiveness of Obinutuzumab in Patients With Chronic Lymphocytic Leukemia Treated in Argentina

Percentage of Participants With Adverse Events (AEs)

时间窗: Up to 24 months

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.

Overall Response Rate

时间窗: Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)

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