Development and Validation of an Approach to Assessing Clinical Relevance of Potential Drug-Drug Interactions Inducing Rare but Serious Adverse Events. [PDF]
Song M +5 more
europepmc +1 more source
Objective DISSOLVE I and II examined the efficacy and safety of nanoencapsulated sirolimus (NAS) plus pegadricase (NASP) in patients with uncontrolled gout (UG). Methods In these double‐blind, placebo‐controlled Phase 3 trials of NASP, patients were randomized 1:1:1 to infusions of high‐dose (HD) or low‐dose (LD) NAS plus pegadricase (HD NASP, LD NASP,
Herbert S. B. Baraf +15 more
wiley +1 more source
Automatic tool for the reconciliation of serious adverse events for pharmacovigilance: design and implementation of Reconciliaid. [PDF]
Contu S +3 more
europepmc +1 more source
Background Non‐melanoma skin cancer (NMSC) is one of the most common malignancies in rheumatoid arthritis (RA). This analysis assessed NMSC risk with Janus kinase inhibitors (JAKi) compared to interleukin‐6 receptor inhibitors (IL‐6Ri). Method This study used data from the British Society for Rheumatology Rheumatoid Arthritis Register (BSRBR‐RA) linked
Zixing Tian +8 more
wiley +1 more source
81 Safeguarding participants when serious adverse events occur in healthcare simulation
Kari Lillemoen-Johansen +1 more
doaj +1 more source
Serious adverse events, readmission, and mortality after shoulder replacement due to fracture, osteoarthritis, and other indications: a population-based comparison with the general population. [PDF]
Larsen JM +5 more
europepmc +1 more source
Objective To assess the pharmacokinetics, effectiveness, safety, and immunogenicity of certolizumab pegol (CZP) in polyarticular‐course juvenile idiopathic arthritis (pcJIA). Methods Pediatric Arthritis Study of Certolizumab Pegol (NCT01550003), a multicenter, open‐label study, enrolled patients 2–17 years with active pcJIA and inadequate response ...
Hermine I Brunner +28 more
wiley +1 more source
Investigation into Safety Profiles of Antiepileptic Drugs and Identification of Predictors for Serious Adverse Events: Insights from National Pharmacovigilance Data. [PDF]
Lee SH +5 more
europepmc +1 more source
Objective To assess the efficacy and safety of deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, in patients with psoriatic arthritis (PsA) who were naive to biologic disease‐modifying antirheumatic drugs or received tumor necrosis factor inhibitors. Methods In the 52‐week (W), double‐blind, placebo‐controlled, phase 3 POETYK PsA‐2 study
Philip J. Mease +20 more
wiley +1 more source
Serious Adverse Events: A Replicability and Validation Study of Naranjo Causality Assessment Tool in a Canadian Clinical Setting. [PDF]
Pradhan P +9 more
europepmc +1 more source

