scholarly journals Association between cancer‐specific adverse event triggers and mortality: A validation study

2020 ◽  
Vol 9 (12) ◽  
pp. 4447-4459
Author(s):  
Saul N. Weingart ◽  
Jason Nelson ◽  
Benjamin Koethe ◽  
Omar Yaghi ◽  
Stephan Dunning ◽  
...  
Keyword(s):  
Adverse Event ◽  
Validation Study ◽  
Specific Adverse Event

scholarly journals Inter-rater reliability of the neonatal adverse event severity scale using real-world Neonatal clinical trial data

2021 ◽  
Author(s):  
Tamorah Lewis ◽  
Norma Terrin ◽  
Jonathan Davis ◽  
Kurt Michels ◽  
Thomas Salaets ◽  
...  
Keyword(s):  
Adverse Event ◽  
Validation Study ◽  
Real World ◽  
Clinical Trial Data ◽  
Trial Data ◽  
The Novel ◽  
Severity Scale ◽  
Rater Reliability ◽  
Intra Class Correlation ◽  
Severity Scores

Abstract Objective The Neonatal Adverse Event Severity Scale (NAESS) was developed to improve scoring of neonatal adverse events (AEs) and accelerate neonatal drug development. This is the first validation study of the novel tool. Study design Retrospective validation study assessing the inter-rater reliability (IRR) of the NAESS. Reviewers used real-world AE data from a neonatal trial. Intra-class correlation (ICC) statistical analysis was performed. Result Sixty AEs were randomly assigned to twelve reviewers for a total of 240 severity scores. Generic and AE-specific NAESS tables were assessed. The ICC was 0.63 (95% confidence interval 0.51 to 0.73). Percent variation due to reviewer and residual error was 0.03 and 0.34, respectively. Conclusion In this first study of the NAESS tool, an ICC of 0.63 indicates moderate reliability. Results highlight the need for improved data collection on neonatal AE forms, augmented training on the NAESS tool, and will inform the prospective validation studies.

Comparison of device‐specific adverse event profiles between Impella platforms

2020 ◽  
Vol 35 (12) ◽  
pp. 3310-3316
Author(s):  
Stacey Chen ◽  
Darien Paone ◽  
Lilly Spellman ◽  
Neel K. Ranganath ◽  
Julius A. Carillo ◽  
...  
Keyword(s):  
Adverse Event ◽  
Specific Adverse Event

scholarly journals Adverse event load, onset, and maximum grade: A novel method of reporting adverse events in cancer clinical trials

2020 ◽  
pp. 174077452095931
Author(s):  
Guilherme S Lopes ◽  
Christophe Tournigand ◽  
Curtis L Olswold ◽  
Romain Cohen ◽  
Emmanuelle Kempf ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Event Reporting ◽  
Data Sets ◽  
Event Data ◽  
Event Reporting ◽  
Adverse Event Data ◽  
Data Points ◽  
First Time ◽  
Reporting Method ◽  
Specific Adverse Event

Background Current adverse event reporting practices do not document longitudinal characteristics of adverse effects, and alternative methods are not easily interpretable and have not been employed by clinical trials. Introducing time parameters in the evaluation of safety that are comprehensive yet easily interpretable could allow for a better understanding of treatment quality. In this study, we developed and applied a novel adverse event reporting method based on longitudinal adverse event changes to aid describing, summarizing, and presenting adverse event profile. We termed it the “Adverse Event Load, Onset, and Maximum Grade” method. Methods We developed two adverse event summary metrics to complement the traditional maximum grade report. Onset time indicates the time period in which the maximum grade for a specific adverse event occurred and was defined as “early” (i.e. maximum grade happened for the first time before 6 weeks) or “late” (i.e. after the 6th week). Adverse event load indicates the overall severity of a specific adverse event over the entire treatment. Higher adverse event load indicates a worse overall experience. These metrics can be calculated for adverse events with different maximum grades, in treatments with planned changes (e.g. dosage changes), using data sets with different number of adverse event data points between treatments (e.g. treatments with longer cycle lengths may have less adverse event data points) and on data sets with different adverse event data availability (e.g. cycle basis and patient-outcome reports). We tested the utility of this method using individual patient data from two major backbone therapies (“Irinotecan” and “Oxaliplatin”) from the N9741 trial available in the Fondation ARCAD database ( fondationarcad.org ). We investigated profiles of diarrhea, neutropenia/leukopenia, and nausea/vomiting. Results Our method provided additional information compared to traditional adverse event reports. For example, for nausea/vomiting, while patients in Irinotecan had a higher risk of experiencing maximum grade 3–4 (15.6% vs 7.6%, respectively; p < 0.001), patients in both groups experienced similar severity over time (adverse effect load = 0.102 and 0.096, respectively; p = 0.26), suggesting that patients in Oxaliplatin experienced a lower-grade but more persistent nausea/vomiting. For neutropenia/leukopenia, more patients in Irinotecan experienced their maximum grade for the first time early in the treatment compared to patients in Oxaliplatin (67.9% vs 41.7%; p < 0.001), regardless of maximum grade. Longitudinal information can help compare treatments or guide clinicians on choosing appropriate interventions for low-grade but persistent adverse event or early adverse event onset. Conclusion We developed an adverse event reporting method that provides clinically relevant information about treatment toxicity by incorporating two longitudinal adverse event metrics to the traditional maximum grade approach. Future research should establish clinical benchmarks for metrics included in this adverse event reporting method.

scholarly journals Fatigue during treatment with antiepileptic drugs: A levetiracetam-specific adverse event?

2017 ◽  
Vol 72 ◽  
pp. 17-21 ◽  
Author(s):  
Marco Mula ◽  
Tim J. von Oertzen ◽  
Hannah R. Cock ◽  
Mahinda Yogarajah ◽  
Dora A. Lozsadi ◽  
...  
Keyword(s):  
Adverse Event ◽  
Antiepileptic Drugs ◽  
Specific Adverse Event

scholarly journals Relationship between mirtazapine dose and incidence of adrenergic side effects: An exploratory analysis

2019 ◽  
Vol 9 (1) ◽  
pp. 41-47 ◽  
Author(s):  
Michael Shuman ◽  
Athena Chukwu ◽  
Nathan Van Veldhuizen ◽  
Steven A. Miller
Keyword(s):  
Adverse Event ◽  
Side Effects ◽  
Neuropsychiatric Symptoms ◽  
Adverse Event Reporting System ◽  
Final Analysis ◽  
Adverse Event Reporting ◽  
The Us ◽  
Increasing Risk ◽  
Higher Doses ◽  
Specific Adverse Event

Abstract Introduction Mirtazapine is an antidepressant with US Food and Drug Administration approval for management of major depressive disorder. Low doses of mirtazapine are often used for management of insomnia, with higher doses expected to provide more noradrenergic effect, and thus a higher degree of activation. If so, use of higher doses at bedtime may not be advisable and may worsen certain neuropsychiatric symptoms. No studies have been performed to evaluate these outcomes. Methods This study consisted of a retrospective review of data submitted to the US Food and Drug Administration's Adverse Event Reporting System from January 1, 1995, to August 1, 2015. Cases that were deemed by study authors to represent activation of the noradrenergic system, and for which other confounders could not be identified, were included in the final analysis. The frequency of each specific adverse event was evaluated based on dose and compared to recent prescribing rates to determine if likelihood of a side effect increased with higher dose. Results The study identified 308 incidences of anxiety, agitation, delusion, hallucination, hypertension, insomnia, nightmare, or tachycardia. After controlling for frequency of prescribing at a given dose, there was a statistically significant increase in rates of tachycardia which correlated with dose. However, after correction for multiple comparisons, results were no longer significant. Discussion This study failed to support the hypothesis that mirtazapine is more activating at higher doses and appears to support the safety of increasing dose without increasing risk of noradrenergic side effects. Prospective studies will be necessary to confirm these findings.

The first step to integrating the child's voice in adverse event reporting in oncology trials: A content validation study among pediatric oncology clinicians

2013 ◽  
Vol 60 (7) ◽  
pp. 1231-1236 ◽  
Author(s):  
Bryce B. Reeve ◽  
Janice S. Withycombe ◽  
Justin N. Baker ◽  
Mary C. Hooke ◽  
Jessica C. Lyons ◽  
...  
Keyword(s):  
Adverse Event ◽  
Pediatric Oncology ◽  
Validation Study ◽  
Adverse Event Reporting ◽  
Content Validation ◽  
Event Reporting

A Validation Study of the Elementary and Advanced Screening Tests of the Clinical Evaluation of Language Functions (CELF)

1983 ◽  
Vol 14 (4) ◽  
pp. 215-222 ◽  
Author(s):  
Sol Ribner ◽  
Laurence Becker ◽  
Sid Marks ◽  
Paul Kahn ◽  
Fred Wolfson
Keyword(s):  
Clinical Evaluation ◽  
Validation Study ◽  
Screening Tests ◽  
Language Functions

1578: A Validation Study of the Sperm Quality Analyzer SQA-V

2004 ◽  
Vol 171 (4S) ◽  
pp. 416-416
Author(s):  
Shai Sheji ◽  
Ruth Weissenberg ◽  
Gil Raviv ◽  
Igael Madgar
Keyword(s):  
Validation Study ◽  
Sperm Quality ◽  
Quality Analyzer ◽  
Sperm Quality Analyzer
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