Serious adverse events reported
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 ...
13
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 ...
150
Serious adverse events and fatal adverse events associated with nivolumab treatment in cancer patients
... been reported in clinical practice [6–12] and have unfortu- nate consequences for the ...organ-specific adverse events and the more prevalent general adverse events related to immune ...
12
Assessment of reported in-patient adverse events: retrospective study of reported adverse events at the Free State Psychiatry Complex from 2008-2010
... that Serious Adverse Events are prevalent in Free State Psychiatry Complex and factors significantly associates with the frequency of aggression-, behavior/occupational health and safety and falls ...
69
Polypectomy Techniques, Endoscopist Characteristics, and Serious Gastrointestinal Adverse Events
... of serious GI adverse events ...studies reported that residual polyp tissues were discovered after cold forceps ...of serious GI adverse events after hot biopsy ...
27
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 ...newly reported data be placed in the context of ...
7
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 ...
6
Signal detection to identify serious adverse events (neuropsychiatric events) in travelers taking mefloquine for chemoprophylaxis of malaria
... spontaneously reported AEs by researchers because they (i) highlight the disproportionality, (ii) allow for estimation of relative risks, (iii) can give rise to less bias than case reports, and (iv) are available ...
6
The Pediatric Index of Mortality as a Trigger Tool for the Detection of Serious Errors and Adverse Events
... Previous studies have established harm rates of 0.37 (9) and 0.40 (7) per admission using trigger lists to identify the most common causes of harm in pediatric inpatient environments. Our SEAE rate of 0.47 per TPA is ...
7
Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles
... are reported with numbers (percentages) and median (quartile 1–3 ...as reported at Clinical- ...not reported in a published article on June 2014 were censored at this date for the estimation of time ...
8
Adverse Events and Preventable Adverse Events in Children
... whereas adverse events that resulted from medication errors were relatively ...4 Serious potential medication errors were found to be 3 times more frequent in children, and very young children, in ...
8
Reported Adverse Drug Events in Infants and Children Under 2 Years of Age
... The adverse event reports identify 1902 different therapeutic drugs, nontherapeutic chemicals, biolog- ical products, vaccines, over-the-counter medica- tions, vitamins, minerals, dietary supplements, blood ...
7
Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi
... well reported in clinical ...commonly reported side effect in the amoxicillin group but attribution to amoxicillin was not ...vomiting events might be attributed to amoxicillin use, as well as other ...
9
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 ...
10
Characterization Of Atrial Fibrillation Adverse Events Reported In Ibrutinib Randomized Controlled Registration Trials
... certain serious comorbidities, patients on the clinical trials were undoubtedly healthier than most treat- ed in general ...bleeding events in 14% of patients were observed in that ...
10
Serious adverse events in patients with idiopathic pulmonary fibrosis in the placebo arms of 6 clinical trials
... This study has several limitations for its implications in day-to-day clinical practice in IPF. The selection process used in choosing the clinical trial populations enforced a selection against conditions that may be ...
6
Profile of serious adverse drug events in a tertiary care hospital of South India - a five years experience
... observed serious ADE which accounted 20% of all the serious ...of adverse drug ...potentially serious in 2% cases. 22 The reported mortality varies from 3 to 10% for ...India, ...
7
Hepatotoxicity associated with sulfasalazine in inflammatory arthritis: A case series from a local surveillance of serious adverse events
... Liver tissue from patient 5, who died, showed expanded portal tracts with a dense inflammatory infiltrate of mononuclear cells, mixed lymphocytes, plasma cells and some blast forms. Bile ducts showed similar inflamma- ...
7
GAO ADVERSE EVENTS. Surveillance Systems for Adverse Events and Medical Errors. Testimony
... of adverse events through studies of this ...that adverse events ...existing adverse event reporting systems about where medical errors are most likely to occur and how much progress, ...
9
Literature review of vaccine-related adverse events reported from HPV vaccination in randomized controlled trials
... In the present literature review, the vaccine was well- tolerated without undue AE. All-type AE and injection- related AE were the only two parameters with a signifi- cantly higher rate in the HPV vaccinated subjects, ...
11