Serious adverse events (SAEs)
Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles
... particular, serious adverse events (SAEs), defined as adverse events that result in death, require inpatient hospitalization or the prolongation of hospitalization, are ...
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Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi
... of serious adverse events (SAEs) within each group as a secondary ...more serious side effects such as abnormal liver function tests, inter- stitial nephritis, seizures and Stevens-Johnson ...
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Impact of cumulative SBP and serious adverse events on efficacy of intensive blood pressure treatment: a randomized clinical trial
... FIGURE 2 Mean SBP trajectories for the intensive treatment and standard treatment groups in Systolic Blood Pressure Intervention Trial. FIGURE 3 Comparison between traditional Cox proportional hazards and cumulative ...
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Hyaluronic acid injection therapy for osteoarthritis of the knee: concordant efficacy and conflicting serious adverse events in two systematic reviews
... A second difference between the two reviews was in the conduct of sensitivity analyses. Our approximation of the SAE analysis by Rutjes and colleagues found that their statistically significant pooled result is sensitive ...
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Antipsychotics-Associated Serious Adverse Events in Children: An Analysis of the FAERS Database
... antipsychotics-associated serious adverse events in ...associated serious adverse events, which possibly lead to fatal ...
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Inhaled steroids with and without regular salmeterol for asthma: serious adverse events.
... in serious adverse events reported in these studies, the FDA mandated surveillance studies of regular salmeterol in adults and ...for serious adverse events for adults and ...
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Signal detection to identify serious adverse events (neuropsychiatric events) in travelers taking mefloquine for chemoprophylaxis of malaria
... about serious adverse events associated with mefloquine ...the serious adverse events of mefloquine, based on data in clinicoepidemiological ...
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In this study, the DCV+ASV regimen had low rates of discontinuation (5%) due to adverse events, and low rates of serious adverse events (5.
... events, and low rates of serious adverse events (5.9%) 1 • Data presentation led AASLD Viral Hepatitis Presidential Plenary session on Tuesday, November 5 UXBRIDGE, UK, November 6, 2013 – ...
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Clinical review: Serious adverse events associated with the use of rituximab a critical care perspective
... fewer adverse events reported as compared with many other chemotherapeutic ...of serious adverse events are being associated with the use of rituximab, often leading to or complicating ...
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<p>Serious Adverse Events in Pediatric Procedural Sedation Before and After the Implementation of a Pre-Sedation Checklist</p>
... However, serious adverse events (SAE) such as aspiration, apnea, and laryngospasm might occur, and because of that it is considered by the Joint Commission on Accreditation of Healthcare ...
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Serious adverse events and fatal adverse events associated with nivolumab treatment in cancer patients
... practitioners and patients cannot properly balance the ben- efits and risks. Previous work has shown that ipilimumab, an immune checkpoint inhibitor targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), was ...
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<p>The safety and serious adverse events of approved ALK inhibitors in malignancies: a meta-analysis</p>
... to adverse events that result in death, are life-threatening, require inpatient hospitalization or extend a current hospital stay, result in an ongoing or signi fi cant incapacity or interfere substantially ...
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Serious adverse events in patients with idiopathic pulmonary fibrosis in the placebo arms of 6 clinical trials
... 2.2. Statistical analysis SAEs reported to the safety database across the 6 trials were described as the number of events and the number of events per 100 patients. Total exposure in patient-exposure years ...
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The impact of dual bronchodilation on cardiovascular serious adverse events and mortality in COPD: a quantitative synthesis<div><br /></div>
... Dovepress LABA/LAMA FDCs and cardiovascular safety in COPD From a strictly analytical point of view, the detected rare/ uncommon frequency of cardiovascular SAEs makes it dif- ficult to get concordant results and, since ...
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Serious adverse events reported in placebo randomised controlled trials of oral naltrexone: a systematic review and meta-analysis
... This review shows the advantages of examining both benefit and risk profiles for drugs and the need for con- sistent and adequate recording of AEs and SAEs in re- ports of RCTs. Recent studies included in this review ...
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Commercial Reimbursement Policy NONPAYMENT FOR SERIOUS ADVERSE EVENTS. Description. Reimbursement Guidelines
... Errors occur not only in hospitals but in other health care settings, such as physicians’ offices, nursing homes, pharmacies, urgent care centers, and care delivered in the home. Unfortunately, very little data exist on ...
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Hepatotoxicity associated with sulfasalazine in inflammatory arthritis: A case series from a local surveillance of serious adverse events
... Determining causality, in cases of suspected drug induced hepatitis, can be difficult not least because of concomitant therapy including possible synergistic effects between potentially hepatotoxic drugs and alcohol use. ...
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National Early Warning Score Accurately Discriminates the Risk of Serious Adverse Events in Patients With Liver Disease.
... NEWS incorporates several parameters that can be deranged in the systemic inflammatory response syndrome (SIRS). This may be relevant to our finding that NEWS performs especially well in ARLD patients, who are ...
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Polypectomy Techniques, Endoscopist Characteristics, and Serious Gastrointestinal Adverse Events
... of serious GI adverse events ...of serious GI adverse events after hot biopsy forceps/ablation and snare ...of serious adverse events after complex ...
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Questions and answers on serious non-fatal adverse events and reporting rules
... non-fatal) serious adverse events be reported? Serious fatal or non-fatal adverse events should be reported in an expedited ...of serious non-fatal adverse ...
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