Side Airbags Deployment Range from Analysis of Event Data Recorder Database of Real-World Incidents

2020 ◽  
Vol 12 (2) ◽  
Author(s):  
Omid Komari ◽  
Mehrdad Javidi ◽  
Zachary Merrill ◽  
Kevin Toosi
Keyword(s):  
Real World ◽  
Event Data

Real-World Safety of Emicizumab: The First Interim Analysis of the European Haemophilia Safety Surveillance (EUHASS) Database

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 29-30
Author(s):  
Aijing Shang ◽  
Nives Selak Bienz ◽  
Ravi Gadiraju ◽  
Tiffany Chang ◽  
Peter Kuebler
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Events ◽  
Real World ◽  
Event Data ◽  
Publicly Traded ◽  
Real World Data ◽  
World Data ◽  
Safety Surveillance ◽  
Adverse Event Data

Introduction: Long-term data from the HAVEN 1-4 clinical trials reaffirmed the safety and efficacy of emicizumab (HEMLIBRA®) prophylaxis in persons with hemophilia A (PwHA; Callaghan M et al. ISTH 2019 presentation). However, early data from the first Phase III trial, HAVEN 1, identified a risk for thrombotic microangiopathy (TMA) or thrombotic events (TEs) when emicizumab was used alongside activated prothrombin complex concentrate (aPCC [FEIBA]; dosed on average a cumulative amount of >100 U/kg/24 hours for ≥24 hours) leading to a warning in the label and ongoing safety monitoring. European Haemophilia Safety Surveillance (EUHASS) is a large pharmacovigilance program that monitors the safety of treatments for inherited bleeding disorders. The EUHASS registry includes real-world data on the use of emicizumab in a broad, representative population of PwHA. The objective of this analysis was to summarize thrombotic, TMA, and anaphylaxis events reported to EUHASS in association with emicizumab prophylaxis. Methods: EUHASS is an investigator-led program with 86 participating centers in 27 countries, with centers reporting information on all the individuals they treat, thus minimizing selection bias. Adverse event data were collected from all PwHA in EUHASS who received emicizumab prophylaxis during 2018. EUHASS adverse event data are not collected according to Medical Dictionary for Regulatory Affairs (MedDRA) classification; however, for this exploratory analysis, events were coded at MedDRA preferred term level as far as possible; endpoints are provided as descriptive statistics. Results: Data from 148 PwHA treated with emicizumab in 2018 were included in this analysis. Concurrent treatments included recombinant activated factor VII (rFVIIa; NovoSeven®; n=23 PwHA), factor VIII, (FVIII products other than Obizur®; n=9 PwHA) and aPCC (n=1 PwHA). Two adverse events were reported in 2018 (Table 1). One event was an acute reaction (rash), reported 48 hours after dosing of a PwHA treated with emicizumab only. He recovered from the rash; the frequency was 0.7% (1/148; 95% confidence interval [CI] 0.02-3.71%). The second event was a TE-a myocardial infarction that occurred 10 hours after emicizumab dosing in a PwHA age >65 years receiving emicizumab and aPCC. The frequency of TE events was calculated as 0.7% (1/148; 95% CI 0.02-3.71%). No TMA or anaphylaxis events were reported. Conclusions: Among PwHA treated with emicizumab at centers participating in EUHASS during 2018, only two adverse events were reported and there were no cases of TMA or anaphylaxis. While a full assessment is reserved for the final analysis, these interim real-world data are not inconsistent with the adverse event profile of emicizumab observed in clinical trials. No new or emerging safety signals for emicizumab were identified. However, this analysis was limited by the low number of emicizumab treated PwHA-especially in those without FVIII inhibitors, and relatively short exposure time to emicizumab. Disclosures Shang: F. Hoffmann-La Roche Ltd: Current Employment, Current equity holder in publicly-traded company, Other: All authors received support for third party writing assistance, furnished by Scott Battle, PhD, provided by F. Hoffmann-La Roche, Basel, Switzerland.. Selak Bienz:F. Hoffmann-La Roche Ltd: Current Employment. Gadiraju:I am 50% shareholder in my own private limited company (Ravi Gadiraju Pharma Ltd): Current equity holder in private company; F. Hoffmann-La Roche Ltd, Safety Scientist (Mar 19 to current): Current Employment; Britannia Pharmaceuticals, Senior PV officer (Feb 17 to Mar 19): Ended employment in the past 24 months. Chang:Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company. Kuebler:Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company.

Comparison of Different Means to Determine Postcrash Velocity in a Real-World Vehicle-Pedestrian Accident

2014 ◽  
Vol 496-500 ◽  
pp. 3031-3033 ◽  
Author(s):  
Sen Su ◽  
Wen Jun Liu ◽  
Fu Ping Wang ◽  
Kui Li ◽  
Zhi Yong Yin
Keyword(s):  
Real World ◽  
Road Traffic ◽  
Accident Reconstruction ◽  
Real Word ◽  
Event Data ◽  
Scientific Rationality ◽  
Vehicle Crash ◽  
Pedestrian Accident ◽  
Conventional Methods

In road traffic collisions, the majority of victims are pedestrians in many countries. Claims in vehicle-pedestrian collision often have to be settled in court. The most concern of vehicle crash accident reconstruction is to retrieve the postcrash velocity. In this study, the conventional methods and Event Data Recorder (EDR) were applied to determine postcrash velocity in a real-word vehicle-pedestrian accident. The study showed limitation and scientific rationality of the conventional methods, and the EDR data of this accident was verified at the same time.

Replications can cause distorted belief in scientific progress

2018 ◽  
Vol 41 ◽  
Author(s):  
Michał Białek
Keyword(s):  
Real World ◽  
Scientific Progress ◽  
The Public ◽  
Psychological Science

AbstractIf we want psychological science to have a meaningful real-world impact, it has to be trusted by the public. Scientific progress is noisy; accordingly, replications sometimes fail even for true findings. We need to communicate the acceptability of uncertainty to the public and our peers, to prevent psychology from being perceived as having nothing to say about reality.

Current Issues: Evidence-Based Practice for the Real World: Thoughts on Clinical Education in Communication Disorders

2010 ◽  
Vol 20 (3) ◽  
pp. 100-105 ◽  
Author(s):  
Anne K. Bothe
Keyword(s):  
Clinical Education ◽  
Real World ◽  
Evidence Based Practice ◽  
Communication Disorders ◽  
University Faculty ◽  
Evidence Based ◽  
Speech Language Pathology ◽  
Basic Principles ◽  
The Real ◽  
Language Pathology

This article presents some streamlined and intentionally oversimplified ideas about educating future communication disorders professionals to use some of the most basic principles of evidence-based practice. Working from a popular five-step approach, modifications are suggested that may make the ideas more accessible, and therefore more useful, for university faculty, other supervisors, and future professionals in speech-language pathology, audiology, and related fields.

Qualitative Case Study Research Design

2015 ◽  
Vol 25 (1) ◽  
pp. 39-45 ◽  
Author(s):  
Jennifer Tetnowski
Keyword(s):  
Research Design ◽  
Real World ◽  
Qualitative Case Study ◽  
Case Study Research ◽  
Study Research

Qualitative case study research can be a valuable tool for answering complex, real-world questions. This method is often misunderstood or neglected due to a lack of understanding by researchers and reviewers. This tutorial defines the characteristics of qualitative case study research and its application to a broader understanding of stuttering that cannot be defined through other methodologies. This article will describe ways that data can be collected and analyzed.

The Real-World Fellowship

2006 ◽  
Vol 40 (7) ◽  
pp. 47
Author(s):  
LEE SAVIO BEERS
Keyword(s):  
Real World ◽  
The Real
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