All were judged treatment-related

All were judged treatment-related. Table 3. Summary of AEs (security population) (%) unless otherwise specified. AEs displayed for preferred terms that had an incidence of 10% (any grade) and/or 5% (grade 3) and/or 2% (SAE). aIncludes the preferred terms neutropenia and neutrophil count decreased. bIncludes the preferred terms thrombocytopenia and platelet count decreased. cIncludes the preferred terms Nav1.7-IN-3 leukopenia and white colored blood cell count decreased. There were no AEs leading to death (grade 5) during the study. severe adverse events were monitored. Results Of 35 individuals treated, 28 completed eight cycles; 31 started shorter period of infusion in Cycle 2 and two individuals in subsequent cycles. Two individuals discontinued before starting shorter duration of infusion. No grade 3 infusion-related reactions occurred in Cycle 2. Twenty-one infusion-related reactions (all marks 1C2) were reported in 17/35 (49%) individuals overall, mostly in Cycle 1 (18/21 infusion-related reactions [86%]). Grade 3 Nav1.7-IN-3 AEs happening in 10% of individuals included neutropenia/neutrophil count decreased (66%) and leukopenia/white blood cell count decreased (23%). Steady-state pharmacokinetics of obinutuzumab were attained in Cycle 2 and were not affected by shorter duration of infusion. No relevant cytokine elevations were reported with shorter period of infusion. Conclusions Regular infusion and shorter period ADRBK1 of infusion of obinutuzumab have similar tolerability and pharmacokinetics in Japanese individuals. (%) unless normally specified. aDiagnosis of both FL and DLBCL. bPatients with FL, = 13. cPatients with disease other than FL, = 22. Infusion-related reactions Overall, 17/35 individuals (49% of the security populace) experienced a total of 21 IRRs; all were grade 1 or 2 2, and the majority [18/21 IRRs (86%)] occurred during Cycle 1 (in which RI was used; Table ?Table2).2). No SDI-associated IRRs occurred in SDI-transition individuals in Cycle 2, so it was not Nav1.7-IN-3 possible to estimate the likelihood that the true probability of a grade 3 IRR in SDI-transition individuals in Cycle 2 would surpass the 5% level inferred using the GATHER study data as the prior distribution. Furthermore, the likelihood that the true probability of a grade 3 IRR in SDI-transition individuals in Cycle 2 would exceed the 5% level inferred using the non-informative prior distribution was 0.05%. Nav1.7-IN-3 There were reports of two patients with IRRs during the SDI in Cycles 6, 7 and 8; all were of grade 1 severity (1 patient experienced nasopharyngitis in Cycle 6, and another experienced headache in Cycles 7 and 8 and palpitations in Cycle 7). The only IRR with an incidence 10% was pyrexia (Table ?(Table2).2). IRRs reported in 5% of patients in any cycle included pyrexia, chills, nausea, blood pressure increase and headache (Table ?(Table22). Table 2. Summary of IRRs (safety population) (%) unless otherwise specified. aThis patient experienced two individual occurrences of headache during C7 and C8. bThis patient experienced two individual occurrences of hyperkalemia on C1D8 and C1D15. Other safety and tolerability endpoints AEs were observed in all 35 patients (Table ?(Table3).3). All patients had at least one AE that was judged by the investigator to be treatment-related. Grade 3 AEs were observed in 30 patients (86%) and were judged treatment-related in 29 patients (83%). Blood and lymphatic system disorders (neutropenia, leukopenia and thrombocytopenia) were among the treatment-related grade 3 AEs most frequently reported (Table ?(Table3).3). Serious AEs were reported in nine patients (26%). All were judged treatment-related. Table 3. Summary of AEs (safety population) (%) unless otherwise specified. AEs displayed for preferred terms that had an incidence of 10% (any grade) and/or 5% (grade 3) and/or 2% (SAE). aIncludes the preferred terms neutropenia and neutrophil count decreased. bIncludes the preferred terms thrombocytopenia and platelet count decreased. cIncludes the preferred terms leukopenia and white blood cell count decreased. There were no AEs leading to death (grade 5) during the study. Obinutuzumab treatment was stopped in three patients because of AEs: one case each of infected dermal cyst, bronchiolitis and aspiration pneumonia. Aspiration pneumonia was not treatment-related. AEs leading to dose reduction or interruption of obinutuzumab treatment occurred in three patients, while AEs leading to dose reduction or interruption of any study drug occurred in nine patients. AEs leading to interruption of any study medication (= 4) were neutropenia, cellulitis, IRR, cerebral infarction or pneumonitis (1 each). Dose reduction of any study medication (= 7) was due to neutropenia/neutrophil count decreased (= 4), leukopenia/white blood cell count decreased (= 3), thrombocytopenia/platelet count decreased (= 3), alanine aminotransferase increased, aspartate aminotransferase increased, neuropathy peripheral, peripheral sensory neuropathy or steroid withdrawal syndrome (1 each)..