2489. Adverse Events with Biktarvy: Post-Marketing Study
نویسندگان
چکیده
منابع مشابه
Post-marketing assessment of neuropsychiatric adverse events in influenza patients treated with oseltamivir: an updated review.
A 2008 review by our group concluded that the risk of neuropsychiatric adverse events (NPAEs) in influenza patients was not increased by oseltamivir exposure, and did not identify any mechanism by which oseltamivir or its metabolites could cause or worsen such events. The current article reviews new information on this topic. Between September 16, 2007 and May 15, 2010, 1,805 spontaneously-repo...
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Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical meas...
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BACKGROUND Many patients discharged from intensive care units (ICU) have complex care needs, placing them at risk of an adverse event in a ward environment. Currently, there is limited understanding of factors associated with these events in the post-intensive care population. A recent study explored intensive care liaison nurses' opinions on factors associated with these events; 25 factors wer...
متن کاملCharacteristics of adverse drug reactions in a vemurafenib early post-marketing phase vigilance study in Japan
BACKGROUND Post-approval research or monitoring is important to determine real-world safety of new products; however, evidence is scant for vemurafenib in Japanese patients. In Japan, a unique system is officially obligated to investigate post-approval safety. Here we report the first adverse drug reaction (ADR) data from vemurafenib-treated Japanese patients with metastatic melanoma. Data were...
متن کاملEffectiveness and adverse events of tolvaptan in octogenarians with heart failure. Interim analyses of Samsca Post-Marketing Surveillance In Heart faiLurE (SMILE study).
The vasopressin receptor 2 (V2) receptor antagonist tolvaptan is an aquaretic agent that has been found to improve symptoms in patients with congestive heart failure. In this study (SMILE study), we administered tolvaptan to patients aged ≥ 80 years with heart failure accompanied by congestive symptoms and compared its effectiveness and safety profiles in this group with those in patients < 80 ...
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ژورنال
عنوان ژورنال: Open Forum Infectious Diseases
سال: 2019
ISSN: 2328-8957
DOI: 10.1093/ofid/ofz360.2167