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https://www.readbyqxmd.com/read/29333595/implanted-closed-loop-gastric-electrical-stimulation-clges-system-with-sensor-based-feedback-safely-limits-weight-regain-at-24%C3%A2-months
#1
S Morales-Conde, I Alarcón Del Agua, L Busetto, F Favretti, M Anselmino, G M Rovera, M Socas-Macias, A Barranco-Moreno, R Province-Azalde, A J Torres
BACKGROUND: Weight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1 year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare. METHODS: Four centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24 months after laparoscopic implantation of a CLGES system...
January 15, 2018: Obesity Surgery
https://www.readbyqxmd.com/read/29333021/efficacy-and-safety-of-ibrutinib-in-indian-patients-with-relapsed-or-refractory-chronic-lymphocytic-leukemia-and-mantle-cell-lymphoma-cases-from-a-named-patient-program
#2
Mohan B Agarwal, Dinesh Bhurani, Chirag Shah, Nitin Sood, Manish Singhal, Anil Kamat, Subash Chezhian, Suryaprakash Mishra, Dinesh Nagrale
Context: This named patient program evaluated the safety and efficacy of ibrutinib, a selective inhibitor of Bruton's tyrosine kinase in Indian patients with relapsed/refractory chronic lymphocytic leukemia (CLL, with/without chromosome 17 deletion [del17p]) and mantle cell lymphoma (MCL). Subjects and Methods: The eight enrolled patients (relapsed/refractory CLL: n = 6 [4/6 patients with del17p] and relapsed/refractory MCL: n = 2) had median age of 55 years (range, 52-60) and had received a median of 3 (CLL patients) and 4 (MCL patients) prior therapies...
October 2017: Indian Journal of Medical and Paediatric Oncology
https://www.readbyqxmd.com/read/29332308/transcatheter-closure-of-patent-foramen-ovale-for-secondary-prevention-of-ischemic-stroke-quantitative-synthesis-of-pooled-randomized-trial-data
#3
Abdul Hakeem, Mehmet Cilingiroglu, Angelos Katramados, Konstantinos Dean Boudoulas, Cezar Iliescu, Betul Gundogdu, Konstantinos Marmagkiolis
OBJECTIVES: To evaluate the safety and efficacy of percutaneous device closure of patent foramen ovale (PFO) for secondary prevention of ischemic stroke BACKGROUND: Stroke remains the leading cause of serious long-term disability in the United States. The effectiveness of a percutaneous PFO closure in the prevention of recurrent cryptogenic strokes has not been established. METHODS: We performed a literature search using PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Google Scholar, and Internet-based sources from January 2003 to September 2017...
January 14, 2018: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/29331635/sotatercept-with-long-term-extension-for-the-treatment-of-anaemia-in-patients-with-lower-risk-myelodysplastic-syndromes-a-phase-2-dose-ranging-trial
#4
Rami Komrokji, Guillermo Garcia-Manero, Lionel Ades, Thomas Prebet, David P Steensma, Joseph G Jurcic, Mikkael A Sekeres, Jesus Berdeja, Michael R Savona, Odile Beyne-Rauzy, Aspasia Stamatoullas, Amy E DeZern, Jacques Delaunay, Gautam Borthakur, Robert Rifkin, Thomas E Boyd, Abderrhamane Laadem, Bond Vo, Jennie Zhang, Marie Puccio-Pick, Kenneth M Attie, Pierre Fenaux, Alan F List
BACKGROUND: Myelodysplastic syndromes are characterised by ineffective erythropoiesis leading to anaemia. Sotatercept (ACE-011) is a novel activin receptor type IIA fusion protein that acts as a ligand trap to neutralise negative regulators of late-stage erythropoiesis. The aim of the study was to establish a safe and effective dose of sotatercept for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes. METHODS: This open-label, multicentre, dose-ranging, phase 2 trial took place at 11 treatment centres in the USA and France...
January 10, 2018: Lancet Haematology
https://www.readbyqxmd.com/read/29330636/a-randomised-trial-comparing-the-pharmacokinetics-and-safety-of-the-biosimilar-ct-p6-with-reference-trastuzumab
#5
Francisco J Esteva, Justin Stebbing, Rebecca N Wood-Horrall, Peter J Winkle, Sung Young Lee, Sang Joon Lee
PURPOSE: Access to trastuzumab, a valuable anti-cancer treatment, can be limited by cost. The primary aim of this study was to evaluate and compare the PK profiles of CT-P6, a biosimilar of trastuzumab, and US-licensed reference trastuzumab (Herceptin®) in healthy subjects. Secondary study aims included comparison of the safety and immunogenicity of CT-P6 and reference trastuzumab in these subjects. METHODS: We performed a single-dose, randomised, double-blind, parallel group study (NCT02665637) comparing CT-P6 with reference trastuzumab (6 mg/kg, 90 min intravenous infusion) in 70 healthy adult males...
January 12, 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29330194/telotristat-ethyl-in-carcinoid-syndrome-safety-and-efficacy-in-the-telecast-phase-3-trial
#6
Marianne E Pavel, David J Gross, Marta Benavent, Petros Perros, Raj Srirajaskanthan, Richard R P Warner, Matthew H Kulke, Lowell Anthony, Pamela Kunz, Dieter Hörsch, Martin O Weickert, Pablo Lapuerta, Wenjun Jiang, Kenneth Kassler-Taub, Suman Wason, Rosanna Fleming, Douglas Fleming, Rocio García-Carbonero
Telotristat ethyl, a tryptophan hydroxylase inhibitor, was efficacious and well tolerated in the Phase 3 TELESTAR study in patients with carcinoid syndrome (CS) experiencing ≥4 bowel movements per day (BMs/day) while on somatostatin analogs (SSAs). TELECAST, a Phase 3 companion study, assessed safety and efficacy of telotristat ethyl in patients with CS (diarrhea, flushing, abdominal pain, nausea, or elevated urinary 5-hydroxyindoleacetic acid [u5-HIAA]) with <4 BMs/day on SSAs (or ≥1 symptom or ≥4 BMs/day if not on SSAs) during a 12-week double-blind treatment period followed by a 36-week open-label extension (OLE)...
January 12, 2018: Endocrine-related Cancer
https://www.readbyqxmd.com/read/29330000/histotripsy-treatment-of-benign-prostatic-enlargement-using-the-vortx-rx-system-initial-human-safety-and-efficacy-outcomes
#7
T G Schuster, J T Wei, K Hendlin, R Jahnke, W W Roberts
OBJECTIVES: To assess clinical safety (primary) and efficacy (secondary) of histotripsy for treatment of symptomatic benign prostatic enlargement (BPE) in a first-in human study. METHODS: Twenty-five male subjects with moderate to severe lower urinary tract symptoms (LUTS), prostate size between 30 and 80 grams and no evidence of prostate cancer were enrolled at two sites in a prospective, single-arm study. Treatment consisted of acoustic energy delivery through the perineum with integrated real-time TRUS monitoring using the Vortx RX system...
January 9, 2018: Urology
https://www.readbyqxmd.com/read/29329957/safety-and-tolerability-of-a-novel-polyclonal-human-anti-mers-coronavirus-antibody-produced-from-transchromosomic-cattle-a-phase-1-randomised-double-blind-single-dose-escalation-study
#8
John H Beigel, Jocelyn Voell, Parag Kumar, Kanakatte Raviprakash, Hua Wu, Jin-An Jiao, Eddie Sullivan, Thomas Luke, Richard T Davey
BACKGROUND: Middle East respiratory syndrome (MERS) is a severe respiratory illness with an overall mortality of 35%. There is no licensed or proven treatment. Passive immunotherapy approaches are being developed to prevent and treat several human medical conditions where alternative therapeutic options are absent. We report the safety of a fully human polyclonal IgG antibody (SAB-301) produced from the hyperimmune plasma of transchromosomic cattle immunised with a MERS coronavirus vaccine...
January 9, 2018: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29329602/abatacept-used-in-combination-with-non-methotrexate-disease-modifying-antirheumatic-drugs-a-descriptive-analysis-of-data-from-interventional-trials-and-the-real-world-setting
#9
Rieke Alten, Harald Burkhardt, Eugen Feist, Klaus Krüger, Juergen Rech, Andrea Rubbert-Roth, Reinhard E Voll, Yedid Elbez, Christiane Rauch
BACKGROUND: Methotrexate (MTX) remains the anchor drug in rheumatoid arthritis (RA) treatment, but is poorly tolerated or contraindicated in some patients. There is a wealth of data supporting the use of abatacept in combination with MTX, but data on alternative conventional synthetic disease-modifying antirheumatic drug (csDMARD) combinations with abatacept are scarce. METHODS: In this post-hoc exploratory analysis, efficacy and safety data were extracted from abatacept RA studies in which combination with csDMARDs other than MTX was permitted: three interventional trials (ATTAIN, ASSURE, and ARRIVE) and one real-world study (ACTION)...
January 2, 2018: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/29329557/one-year-risk-of-serious-infection-in-patients-treated-with-certolizumab-pegol-as-compared-with-other-tnf-inhibitors-in-a-real-world-setting-data-from-a-national-u-s-rheumatoid-arthritis-registry
#10
Leslie R Harrold, Heather J Litman, Katherine C Saunders, Kimberly J Dandreo, Bernice Gershenson, Jeffrey D Greenberg, Robert Low, Jeffrey Stark, Robert Suruki, Srihari Jaganathan, Joel M Kremer, Mohamed Yassine
BACKGROUND: Registry studies provide a valuable source of comparative safety data for tumor necrosis factor inhibitors (TNFi) used in rheumatoid arthritis (RA), but they are subject to channeling bias. Comparing safety outcomes without accounting for channeling bias can lead to inaccurate comparisons between TNFi prescribed at different stages of the disease. In the present study, we examined the incidence of serious infection and other adverse events during certolizumab pegol (CZP) use vs other TNFi in a U...
January 2, 2018: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/29329493/a-randomized-double-blind-controlled-trial-of-intravenous-meloxicam-in-the-treatment-of-pain-following-dental-impaction-surgery
#11
Steven E Christensen, Stephen A Cooper, Randall J Mack, Stewart W McCallum, Wei Du, Alex Freyer
This randomized, controlled phase 2 study was conducted to evaluate the analgesic efficacy, safety, and tolerability of single intravenous (IV) doses of 15 mg, 30 mg, and 60 mg meloxicam compared with oral ibuprofen 400 mg and placebo after dental impaction surgery. The primary efficacy end point was the sum of time-weighted pain intensity differences for 0-24 hours postdose. Among 230 evaluable subjects, meloxicam IV 60 mg produced the greatest reduction in pain, followed by the 30-mg and 15-mg doses. Statistically significant differences in summed pain intensity differences over 24 hours were demonstrated for each active-treatment group vs placebo (favoring active treatment) and for meloxicam IV 30 mg and 60 mg vs ibuprofen 400 mg (favoring meloxicam IV)...
January 12, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29329482/pharmacokinetics-of-rolapitant-in-patients-with-mild-to-moderate-hepatic-impairment
#12
Jing Wang, Xiaodong Wang, Zhi-Yi Zhang, Sujata Arora, Sharon Lu, Vikram Kansra
Rolapitant is a selective and long-acting neurokinin-1 receptor antagonist approved in an oral formulation in combination with other antiemetic agents for the prevention of delayed chemotherapy-induced nausea and vomiting in adults. This was a phase 1 open-label, parallel-group pharmacokinetic and safety study of a single oral dose of 180 mg of rolapitant and its major active metabolite, M19, in subjects with mild and moderate hepatic impairment compared with healthy matched controls. Pharmacokinetics were assessed by a mixed-model analysis of variance of log-transformed values for maximum observed plasma concentration (Cmax ), observed time at Cmax (tmax ), area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-t ), and AUC from time 0 to 120 hours (AUC0-120 ), with hepatic group as a fixed effect...
January 12, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29327055/comparing-neoadjuvant-nab-paclitaxel-vs-paclitaxel-both-followed-by-anthracycline-regimens-in-women-with-erbb2-her2-negative-breast-cancer-the-evaluating-treatment-with-neoadjuvant-abraxane-etna-trial-a-randomized-phase-3-clinical-trial
#13
Luca Gianni, Mauro Mansutti, Antonio Anton, Lourdes Calvo, Giancarlo Bisagni, Begoña Bermejo, Vladimir Semiglazov, Marc Thill, Jose Ignacio Chacon, Arlene Chan, Serafin Morales, Isabel Alvarez, Arrate Plazaola, Milvia Zambetti, Andrew D Redfern, Christian Dittrich, Rebecca Alexandra Dent, Domenico Magazzù, Raffaella De Fato, Pinuccia Valagussa, Ignacio Tusquets
Importance: Studies of neoadjuvant chemotherapy regimens using anthracyclines followed by taxanes have reported a doubling of pathological complete remission (pCR) rates compared with anthracycline-based regimens alone. A reverse sequence did not reduce activity. Nab-paclitaxel is an albumin-bound nanoparticle of paclitaxel that allows for safe infusion without premedication, and its use led to a significantly higher rate of pCR in the GeparSepto trial. Objective: To determine whether nab-paclitaxel improves the outcomes of early and locally advanced human epidermal growth factor receptor 2 (ERBB2/HER2)-negative breast cancer compared with paclitaxel when delivered in a neoadjuvant setting...
January 11, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29326029/neoadjuvant-treatment-with-trastuzumab-and-pertuzumab-plus-palbociclib-and-fulvestrant-in-her2-positive-er-positive-breast-cancer-na-pher2-an-exploratory-open-label-phase-2-study
#14
Luca Gianni, Giancarlo Bisagni, Marco Colleoni, Lucia Del Mastro, Claudio Zamagni, Mauro Mansutti, Milvia Zambetti, Antonio Frassoldati, Raffaella De Fato, Pinuccia Valagussa, Giuseppe Viale
BACKGROUND: In the neoadjuvant setting, blockade of HER2 plus use of an aromatase inhibitor in patients with HER2-positive and oestrogen receptor (ER)-positive breast cancer leads to a pathological complete response in 21% of patients. Convergence of HER2 and ER signals on RB1 suggests that a combined pharmacological intervention directed to these targets could be synergistic. To test this approach, we combined palbociclib to block RB1, fulvestrant to block ER, and trastuzumab with pertuzumab to block HER2 in patients with HER2-positive, ER-positive breast cancer...
January 8, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29325166/drug-safety-and-immunogenicity-of-tumour-necrosis-factor-inhibitors-the-story-so-far
#15
Meghna Jani, William G Dixon, Hector Chinoy
TNF-α inhibitor (TNFi) therapies have transformed the treatment of several rheumatic musculoskeletal diseases. However, the majority of TNFi's are immunogenic and consequent anti-drug antibodies formation can impact on both treatment efficacy and safety. Several controversies exist in the area of immunogenicity of TNFis and drug safety. While anti-drug antibodies to TNFis have been described in association with infusion reactions; serious adverse events (AEs) such as thromboembolic events, lupus-like syndrome, paradoxical AEs, for example, vasculitis-like events and other autoimmune manifestations have also been reported...
January 8, 2018: Rheumatology
https://www.readbyqxmd.com/read/29324372/dislocation-of-a-cerebral-protection-device-component-during-carotid-stenting-a-case-report-of-favorable-outcome-from-conservative-management-after-failure-of-retrieval
#16
Ilaria Tocco-Tussardi, Caterina Kulyk, Vincenzo Vindigni, Giampiero Avruscio
INTRODUCTION: Cerebral-protection devices (CPDs) are a well-established system for reduction of embolic risk in carotid artery angioplasty and stenting (CAS). Although rare, adverse events with CPDs are unpredictable and can be associated with serious outcomes and iatrogenic sequelae. PRESENTATION OF CASE: We describe the unique case of dislocation of a FilterWire EX™ filter loop during right CAS. On trying to recapture the CPD filter at the end of the procedure, the filter loop suddenly detached from the guidewire and dislocated to the proximal middle cerebral artery...
December 28, 2017: International Journal of Surgery Case Reports
https://www.readbyqxmd.com/read/29323459/reliability-and-safety-of-transnasal-compared-to-conventional-endoscopy-for-detecting-esophageal-varices-in-cirrhotic-patients
#17
Elio C Castro Filho, Hugo Perazzo, Raquel Al-Cici P Guimaraes, Lilian Machado, Flavia F Fernandes, Renata M Perez
BACKGROUND & AIMS: Unsedated transnasal endoscopy may be used for detecting esophageal varices. However, few studies evaluated feasibility and accuracy of this technique. We aimed to evaluate accuracy, interobserver agreement and safety of the transnasal ultrathin compared to conventional endoscopy in patients with cirrhosis. METHODS: This cross-sectional study included consecutive patients referred for screening or surveillance of esophageal varices. Patients underwent unsedated transnasal and sedated conventional endoscopies at the same day, which were recorded in a digital video file and randomly analyzed by two double-blinded endoscopists...
January 11, 2018: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/29322510/lolium-perenne-peptide-immunotherapy-is-well-tolerated-and-elicits-a-protective-b-cell-response-in-seasonal-allergic-rhinitis-patients
#18
R Mösges, A F Koch, E Raskopf, J Singh, K Shah-Hosseini, B Hauswald, Y Yarin, F Corazza, L Haazen, S Pirotton, S Allekotte, G Zadoyan, T Legon, S R Durham, M H Shamji
BACKGROUND: Systemic allergic reactions are a risk for allergen immunotherapy that utilizes intact allergen preparations. We evaluated the safety, efficacy and immune mechanisms of short-course treatment with adjuvant-free Lolium perenne peptides (LPP) following a 6-week dose-escalation protocol. METHODS: In a prospective, dose-escalation study, 61 grass pollen-allergic patients received 2 subcutaneous injections of LPP once weekly for 6 weeks. Safety was assessed evaluating local reactions, systemic reactions and adverse events...
January 10, 2018: Allergy
https://www.readbyqxmd.com/read/29322343/rituximab-for-anti-neutrophil-cytoplasmic-antibodies-associated-vasculitis-experience-of-a-single-center-and-systematic-review-of-non-randomized-studies
#19
Gizem Ayan, Sinem Nihal Esatoglu, Gulen Hatemi, Serdal Ugurlu, Emire Seyahi, Melike Melikoglu, Izzet Fresko, Huri Ozdogan, Sebahattin Yurdakul, Vedat Hamuryudan
Rituximab (RTX) is becoming a standard treatment for patients with anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV) but heterogeneity exists regarding its use. We present our uncontrolled experience with RTX in patients with refractory AAV and also the results of a systematic review of non-randomized studies on RTX in AAV patients. We retrospectively reviewed the records of AAV patients treated with RTX following an inadequate response to immunosuppressives between 2011 and 2015. The systematic review covered all English articles listed in PubMed until June 2017...
January 10, 2018: Rheumatology International
https://www.readbyqxmd.com/read/29321075/a-phase-i-open-label-trial-on-the-safety-and-immunogenicity-of-the-adjuvanted-tuberculosis-subunit-vaccine-h1-ic31%C3%A2-in-people-living-in-a-tb-endemic-area
#20
Jemal Hussein, Martha Zewdie, Lawrence Yamuah, Ahmed Bedru, Markos Abebe, Alemnew F Dagnew, Menberework Chanyalew, Asfawesen G Yohannes, Jemal Ahmed, Howard Engers, T Mark Doherty, Peter Bang, Ingrid Kromann, Søren T Hoff, Abraham Aseffa
BACKGROUND: H1/IC31® is a tuberculosis (TB) subunit vaccine candidate consisting of the fusion protein of Ag85B and ESAT-6 (H1) formulated with the IC31® adjuvant. Previous trials have reported on the H1/IC31® vaccine in M. tuberculosis (Mtb)-naïve, BCG-vaccinated and previously Mtb-infected individuals. In this trial, conducted between December 2008 and April 2010, the safety and immunogenicity of H1/IC31® was assessed in participants living in Ethiopia - a highly TB-endemic area...
January 10, 2018: Trials
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