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https://www.readbyqxmd.com/read/27926986/long-term-safety-of-icatibant-treatment-of-patients-with-angioedema-in-real-world-clinical-practice
#1
Andrea Zanichelli, Marcus Maurer, Werner Aberer, Teresa Caballero, Hilary Longhurst, Laurence Bouillet, Vincent Fabien, Irmgard Andresen
The Icatibant Outcome Survey (IOS) is an observational study monitoring safety and effectiveness of icatibant in the real-world setting. We analyzed safety data from 3025 icatibant-treated attacks in 557 patients (enrolled between July 2009 and February 2015). Icatibant was generally well tolerated. Excluding off-label use and pregnancy, 438 patients (78.6%) did not report adverse events (AEs). The remaining 119 (21.4%) patients reported 341 AEs, primarily gastrointestinal disorders (19.6%). Of these, 43 AEs in 17 patients (3...
December 7, 2016: Allergy
https://www.readbyqxmd.com/read/27924687/the-fluad-case-in-italy-could-it-have-been-dealt-differently
#2
Miriam Levi, Ersilia Sinisgalli, Chiara Lorini, Francesca Santomauro, Martina Chellini, Paolo Bonanni
During the influenza vaccination campaign 2014-2015, the reporting of three deaths within 48 hours of vaccination with Fluad brought the Italian Medicines Agency (AIFA) to pronounce the withdrawal of two batches of vaccine, based on the precautionary principle. Investigations by the Istituto Superiore di Sanità, the National Institute of Health, and by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee at the European Medicines Agency (EMA) responsible for monitoring and assessing the safety profiles of human drugs, concluded that there was a lack of causality between the reported deaths and the vaccines administered...
December 7, 2016: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/27924646/influence-of-anti-tnf-immunogenicity-on-safety-in-rheumatic-disease-a-narrative-review
#3
Andrea Matucci, Daniele Cammelli, Fabrizio Cantini, Delia Goletti, Valentina Marino, Giuseppe Maria Milano, Raffaele Scarpa, Giuliano Tocci, Enrico Maggi, Alessandra Vultaggio
Tumor necrosis factor-alpha (TNF-α) antagonists have been shown to be effective in the treatment of chronic inflammatory rheumatic conditions. The use of anti-TNF agents, combined with improved diagnosis, aggressive regimens and regular monitoring, have substantially improved patient outcomes. However, all biological agents are immunogenic, resulting in the formation of anti-drug antibodies (ADAs), which can neutralize drug activity leading to loss of response and potential relapse. In addition, ADAs can also cause serious adverse events such as infusion hypersensitivity reactions...
December 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27923359/dosage-effectiveness-and-safety-of-sertraline-treatment-for-posttraumatic-stress-disorder-in-a-japanese-clinical-setting-a-retrospective-study
#4
Toshiko Kamo, Masaharu Maeda, Misari Oe, Hiroshi Kato, Jun Shigemura, Kazuhiko Kuribayashi, Yuko Hoshino
BACKGROUND: Many of the posttraumatic stress disorder (PTSD) treatment guidelines recognize the use of selective serotonin reuptake inhibitors as first-line pharmacological treatment. In Japan, there were no published studies investigating the effectiveness and safety of sertraline for PTSD in a clinical setting. METHODS: We conducted a retrospective medical chart review of the dosage, effectiveness, and safety of sertraline for the PTSD treatment in Japan. Data were collected from medical charts of patients of PTSD, caused by various types of trauma, who were treated with sertraline between July 2006 and October 2012 during their regular clinical practice...
December 7, 2016: BMC Psychiatry
https://www.readbyqxmd.com/read/27923318/herbal-medicines-challenges-in-the-modern-world-part-5-status-and-current-directions-of-complementary-and-alternative-herbal-medicine-worldwide
#5
Elena Yu Enioutina, Emma R Salis, Kathleen M Job, Michael I Gubarev, Lubov V Krepkova, Catherine Mt Sherwin
Herbal medicine (HM) use is growing worldwide. Single herb preparations, ethnic and modern HM formulations are widely used as adjunct therapies or to improve consumer wellbeing. Areas covered: This final part in the publication series summarizes common tendencies in HM use as adjunct or alternative medicine, education of healthcare professionals and consumers, current and proposed guidelines regulating of production. We discuss potential HM-HM and HM-drug interactions that could lead to severe adverse events in situations where HMs are taken without proper medical professional oversight...
December 7, 2016: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/27922936/the-rejoice-trial-a-phase-3-randomized-controlled-trial-evaluating-the-safety-and-efficacy-of-a-novel-vaginal-estradiol-soft-gel-capsule-for-symptomatic-vulvar-and-vaginal-atrophy
#6
Ginger D Constantine, James A Simon, James H Pickar, David F Archer, Harvey Kushner, Brian Bernick, Gina Gasper, Shelli Graham, Sebastian Mirkin
OBJECTIVE: To evaluate the safety and efficacy of TX-004HR vaginal estradiol soft-gel capsules for moderate-to-severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy. METHODS: In this randomized, double-blind, placebo-controlled, phase 3 study, postmenopausal women with a self-identified most bothersome symptom of dyspareunia received 4, 10, or 25 μg TX-004HR or placebo for 12 weeks. Four co-primary efficacy endpoints were change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH, and severity of dyspareunia...
December 5, 2016: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/27921320/cardiac-effects-of-amiselimod-compared-with-fingolimod-and-placebo-results-of-a-randomised-parallel-group-phase-i-study-in-healthy-subjects
#7
Tomohiko Harada, Darren Wilbraham, Guillemette de La Borderie, Shinsuke Inoue, Jim Bush, A John Camm
AIM: Amiselimod (MT-1303) is a selective sphingosine 1-phosphate 1 (S1P1 ) receptor modulator which is currently being developed for the treatment of various autoimmune diseases. Unlike some other S1P receptor modulators, amiselimod seemed to show a favourable cardiac safety profile in pre-clinical, phase I and II studies. The aim of this study was to characterise the cardiac effects of amiselimod by directly comparing it with fingolimod and placebo. METHODS: Eighty-one (81) healthy subjects aged 18-55 years were equally randomised to receive amiselimod 0...
December 6, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27920513/bronchodilator-efficacy-of-18-%C3%AE-g-once-daily-tiotropium-inhalation-via-discair-%C3%A2-versus-handihaler-%C3%A2-in-adults-with-chronic-obstructive-pulmonary-disease-randomized-active-controlled-parallel-group-open-label-phase-iv-trial
#8
Pinar Yildiz, Mesut Bayraktaroglu, Didem Gorgun, Funda Secik
PURPOSE: To compare the bronchodilator efficacy of 18 μg once-daily tiotropium inhalation administered via Discair(®) versus HandiHaler(®) in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD). PATIENTS AND METHODS: Fifty-eight patients with moderate-to-severe COPD were enrolled in this randomized, active-controlled, parallel-group, open-label, Phase IV non-inferiority trial. Patients were randomly assigned to a test group (n=29, inhalation with Discair) or a reference group (n=29, inhalation with HandiHaler)...
2016: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/27919915/chemoprevention-of-colorectal-cancer-in-individuals-with-previous-colorectal-neoplasia-systematic-review-and-network-meta-analysis
#9
Parambir S Dulai, Siddharth Singh, Evelyn Marquez, Rohan Khera, Larry J Prokop, Paul J Limburg, Samir Gupta, Mohammad Hassan Murad
OBJECTIVE:  To assess the comparative efficacy and safety of candidate agents (low and high dose aspirin, non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs), calcium, vitamin D, folic acid, alone or in combination) for prevention of advanced metachronous neoplasia (that is, occurring at different times after resection of initial neoplasia) in individuals with previous colorectal neoplasia, through a systematic review and network meta-analysis. DATA SOURCES:  Medline, Embase, Web of Science, from inception to 15 October 2015; clinical trial registries...
December 5, 2016: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/27919901/safety-and-pharmacokinetics-of-cd101-iv-a-novel-echinocandin-in-healthy-adults
#10
Taylor Sandison, Voon Ong, Jonathan Lee, Dirk Thye
CD101 IV is a novel echinocandin with distinctive pharmacokinetic properties that is being developed as a once-weekly treatment for candidemia and invasive candidiasis. CD101 has potent in vitro activity and in vivo efficacy against a broad range of Candida and Aspergillus species. The primary objective of two randomized, double-blind, placebo-controlled, dose-escalation studies in healthy adults was to determine the safety and tolerability of CD101 IV. Sequential cohorts of 8 subjects (n=6, active; n=2, placebo) were administered single (50, 100, 200, 400 mg) or multiple once-weekly (100 mg ×2, 200 mg ×2, 400 mg ×3) doses of CD101 IV infused over 1 hour...
December 5, 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27919632/immunogenicity-and-safety-of-a-13-valent-pneumococcal-conjugate-vaccine-and-an-mf59-adjuvanted-influenza-vaccine-after-concomitant-vaccination-in-%C3%A2-60-year-old-adults
#11
Joon Young Song, Hee Jin Cheong, Hak Jun Hyun, Yu Bin Seo, Jacob Lee, Seong-Heon Wie, Min Joo Choi, Won Suk Choi, Ji Yun Noh, Jae Won Yun, Jin Gu Yun, Woo Joo Kim
BACKGROUND: Concomitant administration of influenza and pneumococcal vaccines could be an efficient strategy to increase vaccine uptake among older adults. Nevertheless, immune interference and safety issues have been a concern when more than one vaccines are administered at the same time. METHODS: Subjects aged ⩾60years were randomized in a 1:1:1 ratio to receive MF59-adjuvanted trivalent inactivated influenza vaccine (MF59-aTIV)+13-valent pneumococcal conjugate vaccine (PCV13) (Group 1), PCV13 alone (Group 2), or MF59-aTIV alone (Group 3)...
December 2, 2016: Vaccine
https://www.readbyqxmd.com/read/27919207/safety-and-effectiveness-of-24-week-treatment-with-iguratimod-a-new-oral-disease-modifying-antirheumatic-drug-for-patients-with-rheumatoid-arthritis-interim-analysis-of-a-postmarketing-surveillance-study-of-2679-patients-in-japan
#12
Tsuneyo Mimori, Masayoshi Harigai, Tatsuya Atsumi, Takao Fujii, Masataka Kuwana, Hiroaki Matsuno, Shigeki Momohara, Syuji Takei, Naoto Tamura, Yoshinari Takasaki, Satoshi Ikeuchi, Satoru Kushimoto, Takao Koike
OBJECTIVE: To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, postmarketing surveillance study was conducted. An interim analysis at week 24 was performed. METHODS: This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24...
December 6, 2016: Modern Rheumatology
https://www.readbyqxmd.com/read/27918378/safety-of-infliximab-following-live-virus-vaccination-in-kawasaki-disease-patients
#13
Aaron M Lee, Jane C Burns, Adriana H Tremoulet
No published data are available regarding infliximab use in Kawasaki Disease (KD) patients with recent live virus vaccination. We investigated 38 acute KD patients who received infliximab within 90 days of receiving MMR, VZV, or Rotavirus vaccines. There were no adverse events or serious infections, which suggests that infliximab use in acute KD patients with recent live viral vaccinations is safe.
December 1, 2016: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/27917405/efficacy-and-safety-of-3-week-response-guided-triple-direct-acting-antiviral-therapy-for-chronic-hepatitis-c-infection-a-phase-2-open-label-proof-of-concept-study
#14
George Lau, Yves Benhamou, Guofeng Chen, Jin Li, Qing Shao, Dong Ji, Fan Li, Bing Li, Jialiang Liu, Jinlin Hou, Jian Sun, Cheng Wang, Jing Chen, Vanessa Wu, April Wong, Chris L P Wong, Stella T Y Tsang, Yudong Wang, Leda Bassit, Sijia Tao, Yong Jiang, Hui-Mien Hsiao, Ruian Ke, Alan S Perelson, Raymond F Schinazi
BACKGROUND: To shorten the course of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, we examined the antiviral efficacy and safety of 3 weeks of response-guided therapy with an NS3 protease inhibitor and dual NS5A inhibitor-NS5B nucleotide analogue. METHODS: In this open-label, phase 2a, single centre study, Chinese patients with chronic HCV genotype 1b infection without cirrhosis were randomly allocated by a computer program to one of three treatment groups (sofosbuvir, ledipasvir, and asunaprevir; sofosbuvir, daclatasvir, and simeprevir; or sofosbuvir, daclatasvir, and asunaprevir) until six patients in each group (1:1:1) achieved an ultrarapid virological response (plasma HCV RNA <500 IU/mL by day 2, measured by COBAS TaqMan HCV test, version 2...
October 2016: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/27917309/deutetrabenazine-in-tics-associated-with-tourette-syndrome
#15
Joseph Jankovic, Joohi Jimenez-Shahed, Cathy Budman, Barbara Coffey, Tanya Murphy, David Shprecher, David Stamler
BACKGROUND: Deutetrabenazine, an inhibitor of vesicular monoamine transporter type 2 (VMAT2) depletes presynaptic dopamine and is useful in the treatment of hyperkinetic movement disorders. This study explored the safety, tolerability, and preliminary efficacy of deutetrabenazine in adolescents with moderate-to-severe tics associated with Tourette syndrome (TS). METHODS: In this open-label study of 12-18-year-old patients with TS-related tics, deutetrabenazine was titrated up to 36 mg/day over 6 weeks to adequately suppress tics without bothersome adverse effects (AEs), followed by maintenance at optimal dose for 2 weeks...
2016: Tremor and Other Hyperkinetic Movements
https://www.readbyqxmd.com/read/27917124/the-benefit-and-safety-of-aspirin-for-primary-prevention-of-ischemic-stroke-a-meta-analysis-of-randomized-trials
#16
REVIEW
Hong Lei, Qian Gao, Shan-Rong Liu, Jian Xu
Background: Although aspirin is effective in the secondary prevention of stroke among men and women, its use in primary prevention remains controversial. We conducted a meta-analysis of randomized trials to evaluate the benefit and safety of aspirin for the primary prevention of ischemic stroke. Methods: We searched three electronic databases (Medline, the Cochrane Central Register of Controlled Trials, and Embase) for articles published before August 1st, 2016. Randomized trials reporting the effect of aspirin on the primary prevention of ischemic stroke and its side effects (hemorrhagic stroke and severe gastrointestinal bleeding) were included...
2016: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/27916408/safety-tolerability-and-immunogenicity-of-a-4-antigen-staphylococcus-aureus-vaccine-sa4ag-results-from-a-first-in-human-randomised-placebo-controlled-phase-1-2-study
#17
Robert W Frenck, C Buddy Creech, Eric A Sheldon, David J Seiden, Martin K Kankam, James Baber, Edward Zito, Robin Hubler, Joseph Eiden, Joseph M Severs, Shite Sebastian, Jasdeep Nanra, Kathrin U Jansen, William C Gruber, Annaliesa S Anderson, Douglas Girgenti
BACKGROUND: A prophylactic Staphylococcus aureus four-antigen vaccine (SA4Ag) is under development for prevention of invasive S. aureus disease. A preliminary S. aureus three-antigen vaccine (SA3Ag) was reformulated to include a novel manganese transporter protein (MntC or rP305A). This study describes the first-in-human dose-finding, safety, and immunogenicity results for SA4Ag. METHODS: In this double-blind, sponsor-unblind, placebo-controlled, phase 1/2 study, 454 healthy adults aged 18-64years were randomised to receive a single dose of one of three formulations of SA4Ag with escalating dose levels of rP305A or placebo...
December 1, 2016: Vaccine
https://www.readbyqxmd.com/read/27916406/cortical-excitability-after-pediatric-mild-traumatic-brain-injury
#18
Trevor A Seeger, Adam Kirton, Michael J Esser, Clare Gallagher, Jeff Dunn, Ephrem Zewdie, Omar Damji, Patrick Ciechanski, Karen M Barlow
INTRODUCTION: Mild traumatic brain injury (mTBI) outcomes are variable, and 10-15% may suffer from prolonged symptoms beyond 3 months that impair the child's return to normal activities. Neurophysiological mechanisms of mTBI are incompletely understood, particularly in children, but alterations in cortical excitability have been proposed to underlie post-concussion syndrome. Improved understanding is required to advance interventions and improve outcomes. OBJECTIVE/HYPOTHESIS: To determine if cortical excitability is altered in children with mTBI, and its association with clinical symptoms...
November 19, 2016: Brain Stimulation
https://www.readbyqxmd.com/read/27916398/ruxolitinib-for-the-treatment-of-inadequately-controlled-polycythaemia-vera-without-splenomegaly-response-2-a-randomised-open-label-phase-3b-study
#19
Francesco Passamonti, Martin Griesshammer, Francesca Palandri, Miklos Egyed, Giulia Benevolo, Timothy Devos, Jeannie Callum, Alessandro M Vannucchi, Serdar Sivgin, Caroline Bensasson, Mahmudul Khan, Nadjat Mounedji, Guray Saydam
BACKGROUND: In the pivotal RESPONSE study, ruxolitinib, a Janus kinase (JAK)1 and JAK2 inhibitor, was superior to best available therapy at controlling haematocrit and improving splenomegaly and symptoms in patients with polycythaemia vera with splenomegaly who were inadequately controlled with hydroxyurea. In this study, we assessed the efficacy and safety of ruxolitinib in controlling disease in patients with polycythaemia vera without splenomegaly who need second-line therapy. METHODS: RESPONSE-2 is a randomised, open-label, phase 3b study assessing ruxolitinib versus best available therapy in patients with polycythaemia vera done in 48 hospitals or clinics across 12 countries in Asia, Australia, Europe, and North America...
December 1, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27916205/efficacy-and-safety-of-transdermal-testosterone-in-postmenopausal-women-with-hypoactive-sexual-desire-disorder-a-systematic-review-and-meta-analysis
#20
Chiara Achilli, Jyotsna Pundir, Parimalam Ramanathan, Luca Sabatini, Haitham Hamoda, Nick Panay
OBJECTIVE: To systematically review and summarize the existing evidence related to the efficacy and safety of transdermal T in postmenopausal women for the treatment of hypoactive sexual desire disorder (HSDD). DESIGN: Systematic reviews and meta-analysis. SETTING: Not applicable. PATIENT(S): Seven randomized controlled trials enrolled 3,035 participants; 1,350 women were randomized to treatment with T patch, and 1,379 women were randomized to placebo...
December 1, 2016: Fertility and Sterility
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