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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a study, seven patients (three women and four men) aged 54−63 years were described, who developed veno-occlusive disease (VOD) following treatment with oxaliplatin for follicular lymphoma, diffuse large B-cell lymphoma or mantle cell lymphoma. One of the seven patients was additionally receiving norethisterone [dosages, routes and durations of treatments to reactions onsets not stated; not all outcomes stated].
Case 1: A 54-year-old woman had been diagnosed with grade I-II follicular lymphoma in 2010. Following first line chemotherapy, the disease relapsed in March 2015; she started receiving inductive salvage therapy with R-DHAOx regimen including oxaliplatin, every 3 weeks. She was enrolled in a clinical trial and underwent an autologous stem cell transplantation following...
- Debureaux P-E, et al. Veino-occlusive disease (VOD) during autologous stem cell transplantation (ASCT): Warning about suspected increased incidence after oxaliplatin-containing salvage regimen. HemaSphere 2 (Suppl. 1): 815-816 abstr. PB1785, Jun 2018. Available from: URL: http://doi.org/10.1097/HS9.0000000000000060 [abstract] - France