An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective cohort study of 15 patients, six patients (including two men and one woman) [sexes of the remaining patients not stated] were described, who developed infusion-related allergic reaction, neuroborreliosis, fatal pneumonia, allergic reaction, thrombocytopenia or anaemia following treatment with bendamustine, obinutuzumab or rituximab for chronic lymphocytic leukaemia (CLL) or follicular lymphoma (FL) [exactages at reaction onsets and times to reaction onsets not stated; not all routes and outcomes stated].
A patient, who had CLL, was scheduled to receive 6 cycles of bendamustine and obinutuzumab with an interval of 28 days between each cycle. During the first cycle, the patient received infusion of bendamustine 90 mg/m2body surface area at days 1 and 2, and...
- Pirich T, et al. Tolerability of obinutuzumab therapy in patients with rituximab-relapsed/ refractory B-cell malignancies - a retrospective single center cohort study. Oncotarget 9: 29944-29956, No. 52, 6 Jul 2018. Available from: URL: http://doi.org/10.18632/oncotarget.25714 - AustriaCrossRefPubMedPubMedCentralGoogle Scholar