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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, a patient [age and sex not stated] developed bone pain and local skin reaction following injection of rituximab [indication, time to reaction onset and outcome not stated]. The patient received SC rituximab 1400mg following which the patient developed bone pain and local skin reaction. The patient was consequently hospitalised.
Author comment: "One patient went back to in-hospital administration because of bone pain and local skin reaction related to injection."
- Wolfromm A, et al. Home administration of subcutaneous rituximab is safe and associated with significant cost saving: A single center experience. Blood 130 (Suppl. 1): 4676, Dec 2017. Available from: URL: http://www.bloodjournal.org/content/130/Suppl_1/4676 [abstract] - France