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An event is serious (FDA MedWatch definition) when the patient outcome is:
* congenital anomaly
* requires intervention to prevent permanent impairment or damage
In a retrospective study, a patient [age and sex not stated] was described, who developed digestive bleeding during treatment with gemcitabine [route not stated]. The patient with non-resected pancreatic adenocarcinoma received treatment with 50 mg/m2 gemcitabine twice daily. Subsequently, the patient experienced severe digestive bleeding [duration of treatment to reaction onset and outcome not stated]
Author comment: "All patients experienced G1 to G2 acute toxicity except one patient who presented with severe digestive bleeding potentially linked to the treatment."
- Lauffer D, et al. Non-resected and R1 resected pancreatic adenocarcinoma: Feasibility and patients' outcome after radio-chemotherapy with high dose external radiotherapy (RT). Strahlentherapie und Onkologie 192: 834-835 abstr. 2.2, No. 11, Nov 2016. Available from: URL: http://doi.org/10.1007/s00066-016-1051-3 [abstract] - Switzerland