Clinical Trial Readiness in Limb Girdle Muscular Dystrophy R1 (LGMDR1): A GRASP Consortium Study
ABSTRACT Objective Identifying functional measures that are both valid and reliable in the limb girdle muscular dystrophy (LGMD) population is critical for quantifying the level of functional impairment related to disease progression in order to establish clinical trial readiness in the context of anticipated therapeutic trials.
Stephanie M. Hunn+29 more
wiley +1 more source
Analysis of the time-to-onset of osteonecrosis of jaw with bisphosphonate treatment using the data from a spontaneous reporting system of adverse drug events [PDF]
Mitsuhiro Nakamura+9 more
openalex +1 more source
ABSTRACT Objective To investigate the reliability of very high‐frequency oscillations (VHFOs, 500–2000 Hz) as biomarkers in identifying the epileptogenic zone (EZ) in mesial temporal lobe epilepsy (MTLE) patients. Methods We reviewed 19 MTLE patients who underwent stereo‐electroencephalography‐guided radiofrequency thermocoagulation.
Stéphane Jean+10 more
wiley +1 more source
Chorioamnionitis following vaccination in the Vaccine Adverse Event Reporting System [PDF]
Hema Datwani+3 more
openalex +1 more source
Introduction of Electronic Adverse Event Reporting System [PDF]
OkGu Kim, Byung Joo Park
openaire +1 more source
ADAPT NXT: Fixed Cycles or Every‐Other‐Week IV Efgartigimod in Generalized Myasthenia Gravis
ABSTRACT Objective This phase 3b, open‐label, randomized ADAPT NXT study investigated the efficacy, safety, and tolerability of efgartigimod administered in either a fixed cycles dosing regimen (3 cycles of 4 once‐weekly infusions, with 4 weeks between cycles) or a cycle followed by every‐other‐week (Q2W) dosing.
Ali A. Habib+16 more
wiley +1 more source
ObjectiveThis study aimed to explore the neurological adverse events of oxaliplatin through the Food and Drug Administration Adverse Event Reporting System (FAERS) database and to provide reference for safe clinical drug use.MethodsThe adverse events ...
Xianglin Pan+5 more
doaj +1 more source
Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [PDF]
Antonia V. Bennett+14 more
openalex +1 more source
Objective This work aimed to evaluate the pharmacokinetics, efficacy, and safety of upadacitinib, an oral selective JAK inhibitor, in pediatric patients with polyarticular‐course juvenile idiopathic arthritis (pcJIA). Methods In an open‐label, phase 1 study (SELECT‐YOUTH), enrolled patients, aged 2 to <18 years with pcJIA, received body weight–based ...
Hermine I. Brunner+12 more
wiley +1 more source
Objective Targeted synthetic disease‐modifying antirheumatic drugs (tsDMARDs) have expanded the management of autoimmune diseases, including rheumatic diseases. As the use of these drugs grows, it is important to understand their effects on pregnancy.
Vienna Cheng+7 more
wiley +1 more source