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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A retrospective study involving 83 patients (who had been diagnosed with malaria at the Hospital Clinic of Barcelona, Spain, between January 2015 and December 2017), described four patients [not all sexes stated] aged 40−55 years were described, who developed delayed haemolysis following treatment with artesunate, quinine, dihydroartemisinin or unspecified β-lactams for Plasmodium falciparum malaria [not all dosages, routes and times to reactions onsets stated].
Patient 1 (a 55-year-old patient): The patient, who had been travelling to throughout Zambia, Malawi, Mozambique and South Africa, presented at a hospital in Spain with fever, and was subsequently diagnosed with P. falciparummalaria. The patient was then treated with IV artesunate 2.4 mg/kg. Additionally, the patient...
- Camprubi D, et al. Positive direct antiglobulin test in post-artesunate delayed haemolysis: More than a coincidence?. Malaria Journal 18: 123, No. 1, 8 Apr 2019. Available from: URL: http://doi.org/10.1186/s12936-019-2762-6 - Spain