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Prolonged maintenance with rituximab in indolent NHL
Figure 2. Patients’ disposition during Maintenance II. aTwo additional patients originally intended for randomization failed to meet continuation criteria and were con- sequently not treated in Maintenance II. bDerived by subtracting patients who discontinued from treated patients.
adverse event of grade ≥3 intensity (n=344; 49.7%), most commonly neutropenia (n=160; 23.1%). Febrile neutrope- nia (n=31; 4.5%), pneumonia (n=28; 4.0%) and neutropenia (n=16; 2.3%) were the most commonly reported serious adverse events (occurring in >2% of patients). Infusion/administration-related reactions were reported in 330 patients (47.7%) during Induction; 54 patients (7.8%) had a grade ≥3 event. The most common infusion/adminis- tration-related reaction of any grade during Induction was nausea (n=57; 8.2%); neutropenia was the most common grade ≥3 infusion/administration-related reaction (n=15; 2.2%). At least one treatment-emergent adverse event lead- ing to rituximab discontinuation was reported in 66 patients (9.5%) during Induction, most frequently neu- tropenia (7 patients; 1.0%). At least one treatment-emer- gent adverse event leading to death was reported in 12 patients (1.7%).
Similar incidences of treatment-emergent adverse events were seen across induction chemotherapy regimens (Online Supplementary Table S4). Patients receiving bendamustine experienced more general disorders and administration site conditions overall than those in other groups. Frequencies
of neutropenia reported as an adverse event were similar across induction chemotherapy regimens.
Maintenance I
Treatment-emergent adverse events and serious adverse events were reported in 380/494 (76.9%) and 134/494 (27.1%) patients, respectively, during Maintenance I. At least one treatment-emergent adverse event of grade ≥3 intensity was reported in 163 patients (33.0%), most com- monly neutropenia (n=59; 11.9%). Pneumonia was the most commonly reported serious adverse event affecting >2% of patients during Maintenance I (n=17; 3.4%). Infusion/administration-related reactions were reported in 75 patients (15.2%), with 20 (4.0%) experiencing at least one grade ≥3 event. The most common infusion/adminis- tration-related reaction of any grade was decreased neu- trophil count (n=14; 2.8%). Neutropenia was the most commonly reported grade ≥3 infusion/administration-relat- ed reaction during Maintenance I (9 patients; 1.8%). Rituximab discontinuation due to a treatment-emergent adverse event was reported in 28 patients (5.7%) during Maintenance I. Of these, only neutropenia and pneumonia
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