Articles with "term safety" as a keyword



Long‐term safety and efficacy of left atrial appendage closure in patients with small appendage orifices measured with transesophageal echocardiography

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Published in 2022 at "Clinical Cardiology"

DOI: 10.1002/clc.23950

Abstract: The Watchman device is the most widely used occluder but is indicated in atrial fibrillation (AF) patients with a maximal left atrial appendage (LAA) orifice diameter between 17 and 31 mm. We aimed to compare the… read more here.

Keywords: long term; term safety; safety efficacy; atrial appendage ... See more keywords

Long‐Term Safety and Efficacy of Repeat Treatments with DaxibotulinumtoxinA in Cervical Dystonia: Results from the ASPEN‐Open‐Label Study

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Published in 2025 at "Movement Disorders Clinical Practice"

DOI: 10.1002/mdc3.70104

Abstract: DaxibotulinumtoxinA (DAXI), a novel botulinum neurotoxin (BoNT) formulation, was shown to be safe, effective, and long‐lasting in the treatment of cervical dystonia (CD) over one treatment cycle in the phase 3, randomized, placebo‐controlled ASPEN‐1 trial. read more here.

Keywords: efficacy repeat; long term; term safety; safety efficacy ... See more keywords

Long‐term safety of a structured transition protocol from parenteral prostanoids to selexipag in pulmonary arterial hypertension

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Published in 2022 at "Pulmonary Circulation"

DOI: 10.1002/pul2.12058

Abstract: Abstract There was no structured method for safely transition from parenteral prostanoids to oral medication. We enrolled 37 idiopathic/hereditary pulmonary arterial hypertension patients receiving triple combination therapy including parenteral prostanoids into structured transition program to… read more here.

Keywords: long term; arterial hypertension; term safety; pulmonary arterial ... See more keywords
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Long-term safety and efficacy of opicapone in Japanese Parkinson’s patients with motor fluctuations

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Published in 2021 at "Journal of Neural Transmission"

DOI: 10.1007/s00702-021-02315-1

Abstract: The double-blind part of the COMFORT-PD (COMt-inhibitor Findings from Opicapone Repeated Treatment for Parkinson’s Disease) study in Japanese levodopa-treated patients with Parkinson’s disease and motor fluctuations found that both opicapone 25 and 50 mg were… read more here.

Keywords: long term; safety; time; motor fluctuations ... See more keywords

Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis

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Published in 2019 at "Advances in Therapy"

DOI: 10.1007/s12325-019-01145-8

Abstract: Introduction The safety profile of adalimumab was previously reported in 23,458 patients across multiple indications. Here we report the long-term safety of adalimumab in adults with plaque psoriasis (Ps), hidradenitis suppurativa (HS), rheumatoid arthritis (RA),… read more here.

Keywords: multiple indications; across multiple; long term; safety ... See more keywords

Long-Term Safety and Effectiveness of Adalimumab for Moderate to Severe Psoriasis: Results from 7-Year Interim Analysis of the ESPRIT Registry

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Published in 2017 at "Dermatology and Therapy"

DOI: 10.1007/s13555-017-0198-x

Abstract: IntroductionESPRIT (NCT00799877) is an ongoing 10-year international prospective observational registry evaluating the long-term safety and effectiveness of originator adalimumab in routine clinical practice for adult patients with chronic plaque psoriasis. Herein, we report the long-term… read more here.

Keywords: long term; safety; safety effectiveness; term safety ... See more keywords

Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program.

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Published in 2018 at "Atherosclerosis"

DOI: 10.1016/j.atherosclerosis.2018.08.036

Abstract: BACKGROUND AND AIMS ODYSSEY OLE (open-label extension; NCT01954394) included patients diagnosed with heterozygous familial hypercholesterolemia (HeFH), receiving maximally tolerated statins, who had completed one of four Phase 3 double-blind parent studies (all 18 months' duration),… read more here.

Keywords: week; term; long term; parent ... See more keywords
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Analysis of the COMPARE-AMI trial: First report of long-term safety of CD133+ cells.

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Published in 2020 at "International journal of cardiology"

DOI: 10.1016/j.ijcard.2020.06.004

Abstract: BACKGROUND Data related to long-term safety of intracoronary (IC) injection of CD133+ bone marrow stem cells (BMSC) following an acute myocardial infarction (MI) are still lacking. METHODS COMPARE-AMI is a double-blind, placebo-controlled phase II clinical… read more here.

Keywords: cd133; term safety; trial; long term ... See more keywords

LONG-TERM SAFETY OF TICAGRELOR MONOTHERAPY IN PATIENTS UNDERGOING PCI FOR STABLE CORONARY ARTERY DISEASE IN THE GLOBAL LEADERS STUDY: IMPACT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE

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Published in 2019 at "Journal of the American College of Cardiology"

DOI: 10.1016/s0735-1097(19)30804-6

Abstract: Data on long-term safety and efficacy of ticagrelor in patients with stable coronary artery disease (CAD) and chronic obstructive pulmonary disease (COPD) undergoing percutaneous coronary intervention (PCI) are limited. This is a post-hoc analysis of… read more here.

Keywords: term safety; ticagrelor; stable coronary; long term ... See more keywords

Long-term safety and efficacy of CART-20 cells in patients with refractory or relapsed B-cell non-Hodgkin lymphoma: 5-years follow-up results of the phase I and IIa trials

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Published in 2017 at "Signal Transduction and Targeted Therapy"

DOI: 10.1038/sigtrans.2017.54

Abstract: Long-term safety and efficacy of CART-20 cells in patients with refractory or relapsed B-cell non-Hodgkin lymphoma: 5-years follow-up results of the phase I and IIa trials read more here.

Keywords: cart cells; long term; safety efficacy; efficacy cart ... See more keywords

Long-term safety of ketamine and esketamine in treatment of depression

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Published in 2022 at "Expert Opinion on Drug Safety"

DOI: 10.1080/14740338.2022.2066651

Abstract: ABSTRACT Introduction Ketamine can produce rapid-acting antidepressant effects. Esketamine (Spravato), the S-enantiomer of racemic ketamine, was approved by the FDA for treatment-resistant depression in 2019. Here we review what is known about the long-term safety… read more here.

Keywords: long term; safety; term safety; ketamine esketamine ... See more keywords