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.

Conclusion The findings from this study will present real world safety and efficacy outcomes of high volume centers in Australia using the Pipeline™ Flex Embolization Device incorporating surface modification with Shield Technology™ in contemporary practice.