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However, eculizumab safety based on long\u2010term pharmacovigilance is unknown. This analysis summarises safety data collected from spontaneous and solicited sources from 16 March 2007 through 1 October 2016. Cumulative exposure to eculizumab was 28\u00a0518 patient\u2010years (PY) (PNH, 21\u00a0016 PY; aHUS, 7502 PY). Seventy\u2010six cases of meningococcal infection were reported (0\u00b725\/100 PY), including eight fatal PNH cases (0\u00b703\/100 PY). Susceptibility to meningococcal infections remained the key risk in patients receiving eculizumab. The meningococcal infection rate decreased over time; related mortality remained steady. The most commonly reported serious nonmeningococcal infections were pneumonia (11\u00b78%); bacteraemia, sepsis and septic shock (11\u00b71%); urinary tract infection (4\u00b71%); staphylococcal infection (2\u00b76%); and viral infection (2\u00b75%). There were 434 reported cases of eculizumab exposure in pregnant women; of 260 cases with known outcomes, 70% resulted in live births. Reporting rates for solid tumours (\u22480\u00b76\/100 PY) and haematological malignancies (\u22480\u00b774\/100 PY) remained stable over time. No new safety signals affecting the eculizumab benefit\u2010risk profile were identified. Continued awareness and implementation of risk mitigation protocols are essential to minimise risk of meningococcal and other <jats:italic>Neisseria<\/jats:italic> infections in patients receiving eculizumab.<\/jats:p>","DOI":"10.1111\/bjh.15790","type":"journal-article","created":{"date-parts":[[2019,2,15]],"date-time":"2019-02-15T12:00:37Z","timestamp":1550232037000},"page":"297-310","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":229,"title":["Eculizumab in paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome: 10\u2010year pharmacovigilance analysis"],"prefix":"10.1111","volume":"185","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2114-7533","authenticated-orcid":false,"given":"G\u00e9rard","family":"Soci\u00e9","sequence":"first","affiliation":[{"name":"Hematology\/Transplantation APHP Hospital Saint Louis University Paris VII Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie\u2010Pierre","family":"Caby\u2010Tosi","sequence":"additional","affiliation":[{"name":"Alexion Europe SAS Rueil\u2010Malmaison France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing L.","family":"Marantz","sequence":"additional","affiliation":[{"name":"Alexion Pharmaceuticals, Inc. 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