Mirabegron versus Placebo Add-on Therapy in Men with Overactive Bladder Symptoms Receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia: a Safety Analysis from the Randomized, Phase 4 PLUS Study.
Sign Up to like & getrecommendations! Published in 2020 at "Urology"
DOI: 10.1016/j.urology.2020.09.040
Abstract: OBJECTIVES To analyze the safety of mirabegron add-on therapy in men with overactive bladder symptoms concurrently receiving tamsulosin for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS The Phase 4 PLUS… read more here.
Keywords: add therapy; safety; mirabegron; teaes ... See more keywords
Pooled Analysis of EPS-Like Symptoms in the EMERGENT Program of KarXT in Schizophrenia
Sign Up to like & getrecommendations! Published in 2024 at "CNS Spectrums"
DOI: 10.1017/s1092852924001792
Abstract: Introduction Although atypical antipsychotics have lowered the prevalence and severity of extrapyramidal symptoms (EPS), they still contribute to the overall side-effect burden of approved antipsychotics. Drugs with novel mechanisms without D2 dopamine receptor blocking activity… read more here.
Keywords: schizophrenia; dopamine receptor; karxt; placebo ... See more keywords
Methods to address functional unblinding of raters in CNS trials
Sign Up to like & getrecommendations! Published in 2025 at "Translational Psychiatry"
DOI: 10.1038/s41398-025-03262-1
Abstract: Treatment-emergent adverse events (TEAEs) associated with the unique properties of a pharmaceutical product may functionally unblind clinician ratings, obscure true medication effects, and affect confidence about clinical trial results. Central nervous system studies are particularly… read more here.
Keywords: xanomeline trospium; teaes; placebo; functional unblinding ... See more keywords
Safety profile of lasmiditan in patients with migraine in an Asian population
Sign Up to like & getrecommendations! Published in 2022 at "Expert Opinion on Drug Safety"
DOI: 10.1080/14740338.2022.2087630
Abstract: ABSTRACT Background MONONOFU, a multicenter, randomized, double-blind, placebo-controlled phase 2 study of Japanese patients with migraine, was pivotal for lasmiditan approval in Japan. However, treatment-emergent adverse events (TEAEs) were more common than in global studies.… read more here.
Keywords: safety; patients migraine; profile lasmiditan; teaes ... See more keywords
1976. Pooled Analysis of Safety Data From Phases 2 and 3 Clinical Trials Evaluating Eravacycline in Complicated Intra-Abdominal Infections
Sign Up to like & getrecommendations! Published in 2018 at "Open Forum Infectious Diseases"
DOI: 10.1093/ofid/ofy210.1632
Abstract: Abstract Background Eravacycline is a novel, fully synthetic fluorocycline antibiotic that was evaluated in three comparator-controlled studies for the treatment of complicated intra-abdominal infections (cIAI). The objective of this analysis was to evaluate the safety… read more here.
Keywords: analysis; treatment; eravacycline q12h; safety ... See more keywords
Pooled analysis on characteristics of nausea and vomiting in patients receiving trastuzumab deruxtecan (T-DXd) in clinical studies.
Sign Up to like & getrecommendations! Published in 2024 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2024.42.16_suppl.12118
Abstract: 12118 Background: The efficacy and safety profile of T-DXd has been established in patients (pts) with various tumor types, and nausea and vomiting are the most common treatment-emergent adverse events (TEAEs). T-DXd study protocols were… read more here.
Keywords: treatment; dxd; analysis; teaes ... See more keywords
Guidelines for Management of Treatment-Emergent Adverse Events During Rucaparib Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer
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DOI: 10.2147/cmar.s335962
Abstract: Purpose The US Food and Drug Administration has recently granted accelerated approval of the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib as treatment for men with metastatic castration-resistant prostate cancer (mCRPC) associated with a deleterious germline or… read more here.
Keywords: management; rucaparib treatment; treatment; teaes ... See more keywords