Post-Marketing Surveillance of the Safety and Effectiveness of Cabozantinib in Japanese Patients With Advanced Renal Cell Carcinoma. [PDF]
Kanayama HO, Kuroda S, Osaka T, Eto M.
europepmc +1 more source
Abstract Objective To compare the incidence of hostility‐ and aggression‐related adverse events in children with focal‐onset seizures (FOS), with or without focal to bilateral tonic–clonic seizures (FBTCS), receiving perampanel as monotherapy or in combination with other antiseizure medications (ASMs).
Yukitoshi Takahashi +5 more
wiley +1 more source
Analysis of Mandatory Post-Marketing Surveillance Studies Supports Revised Regulatory Requirements in Korea. [PDF]
Wolter K +7 more
europepmc +1 more source
Seizure forecasting: The long and winding road to clinical translation
Abstract Seizure forecasting has progressed from theoretical aspiration to a rapidly advancing research domain, yet clinical translation remains limited. Over the past decades, advances in algorithm development, chronic electroencephalography (EEG), wearable sensors, and the characterization of seizure cycles have demonstrated that seizure risk is not ...
Philippa J. Karoly +7 more
wiley +1 more source
Safety and Effectiveness of Inebilizumab in Patients with Neuromyelitis Optica Spectrum Disorder: Interim Analysis of a Post-marketing Surveillance in Japan. [PDF]
Fujihara K +6 more
europepmc +1 more source
Abstract Objective Epilepsy is a common condition associated with significant morbidity, mortality, and costs. Poor documentation of seizures is a major challenge in epilepsy care. Objective seizure counting with mobile devices may mitigate this challenge and improve patient management.
Matthew McWilliam +8 more
wiley +1 more source
Editorial Comment From Dr. Kato to Post-Marketing Surveillance of the Safety and Effectiveness of Cabozantinib in Japanese Patients With Advanced Renal Cell Carcinoma. [PDF]
Kato T, Matsukawa A, Nonomura N.
europepmc +1 more source
This graphical abstract provides an overview of the content from this post hoc analysis evaluating the efficacy and safety of fenfluramine in patients with Dravet syndrome stratified by age, number of previously attempted antiseizure medications, and SCN1A pathogenic variant status using data pooled from the three pivotal randomized controlled trials ...
Rima Nabbout +20 more
wiley +1 more source
Real-World Safety and Effectiveness of Cabotegravir in People Living with HIV: Interim Report of a Post-marketing Surveillance in Japan. [PDF]
Yoshikawa Y +8 more
europepmc +1 more source
Technologies of Suspicion: Coercion and Compassion in Post-disciplinary Surveillance Regimes.
Drug-use surveillance systems appear in this paper as symptomatic “technologies of suspicion” that constitute a set of empirical modes for producing and interpreting “data” or test results in ways that conflate prediction with prescription, acting as ...
Campbell, Nancy D.
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