Moxifloxacin prophylaxis is associated with higher bacteraemia and adverse event rates than levofloxacin prophylaxis in patients with cancer during neutropenia,

AbstractPatients with cancer are currently prioritized in coronavirus disease 2019 (COVID-19) vaccination programs globally, which includes administration of mRNA vaccines. Cytokine release syndrome (CRS) has not been reported with mRNA vaccines and is an extremely rare immune-related adverse event of immune checkpoint inhibitors. We present a case of CRS that occurred 5 d after vaccination with BTN162b2 (tozinameran)—the Pfizer-BioNTech mRNA COVID-19 vaccine—in a patient with colorectal cancer on long-standing anti-PD-1 monotherapy. The CRS was evidenced by raised inflammatory markers, thrombocytopenia, elevated cytokine levels (IFN-γ/IL-2R/IL-18/IL-16/IL-10) and steroid responsiveness. The close temporal association of vaccination and diagnosis of CRS in this case suggests that CRS was a vaccine-related adverse event; with anti-PD1 blockade as a potential contributor. Overall, further prospective pharmacovigillence data are needed in patients with cancer, but the benefit–risk profile remains strongly in favor of COVID-19 vaccination in this population.

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The Irish National Adverse Event Study-2 (INAES-2): longitudinal trends in adverse event rates in the Irish healthcare system

BMJ Quality & Safety ◽

10.1136/bmjqs-2020-011122 ◽

2021 ◽

pp. bmjqs-2020-011122 ◽

Cited By ~ 1

Author(s):

Warren Connolly ◽

Natasha Rafter ◽

Ronan M Conroy ◽

Cornelia Stuart ◽

Anne Hickey ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Positive Impact ◽

Retrospective Chart Review ◽

Published Data ◽

National Programmes ◽

Event Rates ◽

Hospital Associated Infections ◽

Design And Methods ◽

The Impact

ObjectivesTo quantify the prevalence and nature of adverse events in acute Irish hospitals in 2015 and to assess the impact of the National Clinical Programmes and the National Clinical Guidelines on the prevalence of adverse events by comparing these results with the previously published data from 2009.Design and methodsA retrospective chart review of 1605 admissions to eight Irish hospitals in 2015, using identical methods to those used in 2009.ResultsThe percentage of admissions associated with one or more adverse events was unchanged (p=0.48) at 14% (95% CI=10.4% to 18.4%) in 2015 compared with 12.2% (95% CI=9.5% to 15.5%) in 2009. Similarly, the prevalence of preventable adverse events was unchanged (p=0.3) at 7.4% (95% CI=5.3% to 10.5%) in 2015 compared with 9.1% (95% CI=6.9% to 11.9%) in 2009. The incidence densities of preventable adverse events were 5.6 adverse events per 100 admissions (95% CI=3.4 to 8.0) in 2015 and 7.7 adverse events per 100 admissions (95% CI=5.8 to 9.6) in 2009 (p=0.23). However, the percentage of preventable adverse events due to hospital-associated infections decreased to 22.2% (95% CI=15.2% to 31.1%) in 2015 from 33.1% (95% CI=25.6% to 41.6%) in 2009 (p=0.01).ConclusionAdverse event rates remained stable between 2009 and 2015. The percentage of preventable adverse events related to hospital-associated infection decreased, which may represent a positive impact of the related national programmes and guidelines.

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Observed and expected serious adverse event rates in randomised clinical trials for hypertension: an observational study comparing trials that do and do not focus on older people

The Lancet Healthy Longevity ◽

10.1016/s2666-7568(21)00092-1 ◽

2021 ◽

Author(s):

Peter Hanlon ◽

Neave Corcoran ◽

Guy Rughani ◽

Anoop S V Shah ◽

Frances S Mair ◽

...

Keyword(s):

Clinical Trials ◽

Adverse Event ◽

Observational Study ◽

Older People ◽

Randomised Clinical Trials ◽

Serious Adverse Event ◽

Event Rates

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Parenteral Iron Therapy: A Single Institution's Experience Over a 5-Year Period

Journal of the National Comprehensive Cancer Network ◽

10.6004/jnccn.2005.0047 ◽

2005 ◽

Vol 3 (6) ◽

pp. 791-795 ◽

Cited By ~ 10

Author(s):

Christopher A. Laman ◽

Scott B. Silverstein ◽

George M. Rodgers

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Iron Sucrose ◽

Iron Therapy ◽

Iron Dextran ◽

Serious Adverse Events ◽

Exact Test ◽

Parenteral Iron ◽

Parenteral Iron Therapy ◽

Event Rates

Many patients require parenteral iron therapy for optimal correction of anemia, including cancer patients who require erythropoietic drugs. Available parenteral iron therapy options include iron dextran, iron gluconate, and iron sucrose. The purpose of this study is to summarize our institution's experience with parenteral iron therapy over a 5-year period, with a focus on comparative safety profiles. All patients receiving parenteral iron therapy over this period were included in the analysis. Chi-squared test and Fisher's exact test were used to compare the adverse event rates of each product. A total of 121 patients received 444 infusions of parenteral iron over this period. Iron dextran was the most commonly used product (85 patients) and iron sucrose was the least used (2 patients). Iron gluconate was used by 34 patients. Overall adverse event rates per patient with iron dextran and iron gluconate were 16.5% and 5.8%, respectively (P = .024). Premedication with diphenhydramine and acetaminophen before infusions of iron dextran reduced adverse event rates per infusion from 12.3% to 4.4% (P = .054). Test doses of iron dextran were used 88% of the time for initial infusions of iron dextran. All adverse events for all parenteral iron products were mild or moderate. There were no serious adverse events and no anaphylaxis was observed. Our results suggest that, if test doses and premedications are used, iron dextran is an acceptable product to treat iron deficiency.

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The efficacy of remdesivir in coronavirus disease 2019 (COVID-19): a systematic review

Iranian Journal of Microbiology ◽

10.18502/ijm.v12i5.4597 ◽

2020 ◽

Author(s):

Amirhossein Roshanshad ◽

Alireza Kamalipour ◽

Mohammad Ali Ashraf ◽

Romina Roshanshad ◽

Sirous Jafari ◽

...

Keyword(s):

Systematic Review ◽

Adverse Event ◽

Cohort Studies ◽

Clinical Improvement ◽

Day Treatment ◽

Mortality Rates ◽

Severe Adverse Event ◽

Adverse Event Rate ◽

Significant Difference ◽

Event Rates

Background and Objectives: Researchers all around the world are working hard to find an effective treatment for the new coronavirus 2019. We performed a comprehensive systematic review to investigate the latest clinical evidence on the efficacy and safety of treatment with Remdesivir in hospitalized patients with COVID-19. Materials and Methods: We performed a systematic search in Pubmed, Embase, Web of Science, Google scholar and MedRxiv for relevant observational and interventional studies. The outcomes measures were mortality rates, improvement rates, time to clinical improvement, all adverse event rates and severe adverse event rates. Results: Three randomized controlled trials and 2 cohort studies were included in our study. In the 2 cohort studies, patients received Remdesivir for 10 days. 2 RCTs evaluated 10-day efficacy of treatment with Remdesivir versus placebo group and the other RCT compared its 5-day regimen versus 10-day regimen. Visual inspection of the forest plots revealed that the efficacy of Remdesivir was not much different in reducing 28-day mortality versus 14-day mortality rates. Besides, 10-day treatment regimen overpowered 5-day treatment and placebo in decreasing time to clinical improvement. All adverse event rates did not have a significant difference; however, severe adverse event rate was lower in the 5-day Remdesivir group compared to the 10-day and placebo groups. Conclusion: 5-day course of Remdesivir therapy in COVID-19 patients is probably efficacious and safe, and patients without invasive mechanical ventilation benefit the most. Treatment can be extended to 10 days if satisfactory improvement is not seen by day 5. Most benefits from Remdesivir therapy take place in the first 14 days of the start of the treatment.

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