Introduction to Real World Safety

Background There is limited real-world safety information on palbociclib for treatment of advanced stage HR+/HER2- breast cancer.

To evaluate the real-world safety and efficacy of AAP as first-line and second-line [post-docetaxel only (AAP-PD)] treatment in patients with mCRPC.

This study aimed to investigate the real-world safety of cold snare polypectomy during antithrombotic therapy.

These data are used to define outcomes, such as fractures, and are critical to determining real-world safety and effectiveness of medications.

It is uniquely able to immerse trainees in extreme situations that are too risky or dangerous to be examined in traditional real-world safety training.

BACKGROUND A post-marketing surveillance study (STANDARD-VTE) evaluated the real-world safety and effectiveness of apixaban in Japanese patients prescribed for either the treatment of venous thromboembolism (VTE) or prevention of recurrent VTE.

Objective : To report real-world safety data of the COVID-19 vaccines in persons with rare neuroimmunological diseases.

For this purpose, the safety performance function (SPF) and crash modification factor (CMF) were developed to reflect real-world safety impacts.

AIMS To examine the real-world safety of adding bevacizumab to first-line irinotecan-based chemotherapy for patients with metastatic colorectal cancer (mCRC).

We investigated its real-world safety and effectiveness in Japanese patients with systemic lupus erythematosus (SLE).

Given the abundant clinical experience and real-world safety data with the currently existing therapy, any novel agent for CHB should be accompanied by convincing safety data.

The Headache Study Group of the Spanish Neurological Society started a registry to monitor real-world safety and efficacy, and all Spanish headache experts were invited to participate.

For payers, this expansion presents challenges in balancing well-established treatments with new options that cost more and have lesser known real-world safety and efficacy.

This study evaluates real-world safety and treatment outcomes of non-trial nivolumab use.

Because of an earlier market introduction, more real-world safety data are available for tramadol, including data from at-risk patient subgroups.

OBJECTIVES This study sought to investigate the incidence and characteristics of the real-world safety profile of second-generation cryoballoon ablation (2nd-CBA) in Japan.

More precisely, we describe how to make adjustments to existing driving policies so to satisfy real-world safety requirements, rather than only obeying to the law and traffic rules.

This is in conjunction with reduced times for trial follow-up post-immunisation and the use of post-implementation safety surveillance programs to monitor real-world safety.

Conclusion: The real-world safety and effectiveness data of regorafenib in metastatic colorectal cancer in France align with findings from Phase III clinical trials and the global CORRELATE population.

Current methods of analyzing data from naturalistic driving studies provide important insights into real-world safety-related driving behaviors, but are limited in the depth of information they currently offer.

Long-term, real-world safety and effectiveness data are required to support biosimilar use.

To meet the conditions of approval, an all-case post-marketing surveillance study was conducted to confirm the real-world safety and efficacy of rituximab in patients of all ages with refractory nephrotic syndrome.

However, some of the patterns we have shown lack face-validity to clinicians familiar with real-world safety data.

This postmarketing surveillance study evaluated the real-world safety and effectiveness of nivolumab as salvage (after ≥ 2 lines) therapy in Japanese patients with unresectable advanced or recurrent gastric/gastroesophageal junction (G/GEJ) cancer.

BACKGROUND Real-world safety and effectiveness data for trastuzumab plus chemotherapy treatment of human epidermal growth factor receptor 2 (HER2)-positive metastatic gastric cancer (mGC) patients in China are lacking.

Lay abstract Real-world safety experience with immune checkpoint inhibitors in Saudi Arabia: Immune Checkpoint Inhibitors (ICIs) are rapidly growing and changing cancer care.

The aim of this post-marketing surveillance (PMS) study is to evaluate the real-world safety and efficacy of CT-P13, the first biosimilar of infliximab (IFX).

Introduction Phase IV post-marketing surveillance studies are needed to evaluate the real-world safety and effectiveness of drug products.

To the Editor: We read with great interest the article by Schultz et al (1) on real-world safety of implantable spinal cord stimulation (SCS) systems.

In April 2019, the National Agency for the Safety of Medicines and Health Products (ANSM) of France issued a warning for NSAID uses by patients with infectious diseases based on an analysis of 20 years of real-world safety data on ibuprofen and ketoprofen.

The real-world safety profile of monoclonal antibodies showed varying adverse event patterns than those reported in previous clinical trials.

Use of ustekinumab in Crohn’s disease was approved in 2016, and consequently data regarding its real-world safety are still limited.

Ultimately, although some uncertainty remains, the study by Dave and colleagues (7) provides encouraging evidence of the real-world safety of SGLT-2 inhibitors, allowing patients to benefit from their use with greater confidence in their safety with respect to severe UTI.

DiscussionIf this trial shows a reduction in severe or invasive infection incidence, it would be the basis for a multi-site, multi-country clinical trial to assess real-world safety and efficacy of zinc in African children with SCA.

Conclusions While EMR data have limitations, the real-world safety outcome with individual chemotherapy regimen could be considered for the better selection of platinum-based therapies in NSCLC.

PURE is a multinational registry that will assess the real-world safety and effectiveness of secukinumab and other approved therapies in the management of patients with moderate to severe psoriasis.

We report real-world safety and efficacy of G/P in HCV-TARGET participants.

A plethora of studies have shown that state-of-the-art DL systems suffer from defects and vulnerabilities that can lead to severe loss and tragedies, especially when applied to real-world safety-critical applications.

Thus, one of the main advantages is the possibility to study the real-world safety and effectiveness of medications in uncontrolled environments.

Objective: To evaluate the real-world safety and curative effect of ombitasvir combined with dasabuvir for the treatment of chronic hepatitis C 1b genotype infection in non-cirrhotic or compensated cirrhotic patients.

The World Health Organization guidelines recommend lopinavir/ritonavir (LPV/r) as a second-line antiretroviral therapy (ART) for HIV-infected adults in middle-income and low-income countries as a protease inhibitor boost based on clinical trials; however, the real-world safety and efficacy remain unknown.

Real-world safety event rates of major adverse cardiovascular events (MACE), serious infectious events (SIEs) and herpes zoster (HZ; serious and non-serious) were compared in pts with RA who started tofacitinib or a bDMARD regardless of dose/schedule between 6 Nov 2012 (US FDA approval) and 30 Jun 2017 (follow-up through 31 Dec 2017).

Herein, we aimed to evaluate the real-world safety of MRI in these patients.

We review the clinical trial and real-world safety data to date on these agents as well as review new data and considerations with anti-tumor necrosis factor agents.

PurposeThe prospective, multicenter Revive Acute ischemic stroke Patients ImmeDiately (RAPID) trial was carried out to evaluate the real-world safety and efficacy of the Revive SE stent retriever.

Research design and methods: This 2-year post-marketing surveillance (PMS) assessed the real-world safety and efficacy of vildagliptin therapy in 19,218 Japanese T2DM patients.

Additional real-world safety data for SB4 via pharmacovigilance studies are needed to draw conclusions regarding the risks of rare adverse events such as serious infections and malignancy.

The aim was to compare real-world safety and efficacy of BAF (Attain Stability, Medtronic Plc.

Assessments The primary objective of the ETNA-AF-Europe study is to assess the real-world safety of edoxaban by evaluating bleeding events, including intracranial hemorrhage; drug-related adverse events, such as hepatic events; and cardiovascular and all-cause mortality.

PRINCIPAL, a prospective, observational study, was designed to confirm the real-world safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC).

Further recruitment and follow-up patients will allow for analysis of real-world safety and effectiveness, but differences in patient characteristics will need to be considered in any comparative effectiveness analyses.

An all-case, post-marketing surveillance (PMS) study is being conducted in Japan to assess the long-term, real-world safety and effectiveness of tafamidis in patients with ATTR-FAP (study period, November 2013 to May 2021).

OBJECTIVE To present PMMA-collagen gel PMSD findings on real-world safety.