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https://www.readbyqxmd.com/read/28528311/rapid-screening-and-identification-of-chemical-hazards-in-surface-and-drinking-water-using-high-resolution-mass-spectrometry-and-a-case-control-filter
#1
Sarit L Kaserzon, Amy L Heffernan, Kristie Thompson, Jochen F Mueller, Maria Jose Gomez Ramos
Access to clean, safe drinking water poses a serious challenge to regulators, and requires analytical strategies capable of rapid screening and identification of potentially hazardous chemicals, specifically in situations when threats to water quality or security require rapid investigations and potential response. This study describes a fast and efficient chemical hazard screening strategy for characterising trace levels of polar organic contaminants in water matrices, based on liquid chromatography high resolution mass spectrometry with post-acquisition 'case-control' data processing...
May 12, 2017: Chemosphere
https://www.readbyqxmd.com/read/28528210/do-patients-need-to-stay-in-bed-all-day-in-the-epilepsy-monitoring-unit-safety-data-from-a-non-restrictive-setting
#2
Laura Craciun, Jørgen Alving, Elena Gardella, Daniella Terney, Pirgit Meritam, Melita Cacic Hribljan, Sándor Beniczky
PURPOSE: To assess whether injuries occur more often in an Epilepsy Monitoring Unit (EMU) where portable EEG amplifiers are used, and where patients can freely move within a large area during the monitoring. METHODS: Patients were monitored at the Danish Epilepsy Center, in an EMU specifically designed for this purpose, and they were under continuous surveillance by personnel dedicated to the EMU. Adverse events (AEs) - including injuries, were prospectively noted, as part of the safety policy of the hospital...
May 13, 2017: Seizure: the Journal of the British Epilepsy Association
https://www.readbyqxmd.com/read/28527704/anti-madcam-antibody-pf-00547659-for-ulcerative-colitis-turandot-a-phase-2-randomised-double-blind-placebo-controlled-trial
#3
Séverine Vermeire, William J Sandborn, Silvio Danese, Xavier Hébuterne, Bruce A Salzberg, Maria Klopocka, Dino Tarabar, Tomas Vanasek, Miloš Greguš, Paul A Hellstern, Joo Sung Kim, Miles P Sparrow, Kenneth J Gorelick, Michelle Hinz, Alaa Ahmad, Vivek Pradhan, Mina Hassan-Zahraee, Robert Clare, Fabio Cataldi, Walter Reinisch
BACKGROUND: PF-00547659 is a fully human monoclonal antibody that binds to human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) to selectively reduce lymphocyte homing to the intestinal tract. We aimed to assess the efficacy and safety of PF-00547659 in patients with moderate to severe ulcerative colitis. METHODS: This phase 2, randomised, double-blind, placebo-controlled clinical trial recruited patients aged 18-65 years from 105 centres in 21 countries, with a history (≥3 months) of active ulcerative colitis extending more than 15 cm beyond the anal verge (with a total Mayo score ≥6 and a Mayo endoscopic subscore ≥2) who had failed or were intolerant to at least one conventional therapy...
May 17, 2017: Lancet
https://www.readbyqxmd.com/read/28527133/a-phase-ii-study-of-antibody-drug-conjugate-tak-264-mln0264-in-previously-treated-patients-with-advanced-or-metastatic-pancreatic-adenocarcinoma-expressing-guanylyl-cyclase-c
#4
Khaldoun Almhanna, David Wright, Teresa Macarulla Mercade, Jean-Luc Van Laethem, Antonio Cubillo Gracian, Carmen Guillen-Ponce, Jason Faris, Carolina Muriel Lopez, Richard A Hubner, Johanna Bendell, Alain Bols, Jaime Feliu, Naureen Starling, Peter Enzinger, Devalingham Mahalingham, Wells Messersmith, Huyuan Yang, Adedigbo Fasanmade, Hadi Danaee, Thea Kalebic
Background This phase II open-label, multicenter study evaluated the efficacy, safety, and tolerability of TAK-264 in previously treated patients with advanced or metastatic pancreatic adenocarcinoma expressing guanylyl cyclase C (GCC). Methods Patients with advanced or metastatic pancreatic adenocarcinoma expressing GCC (H-score ≥ 10) received TAK-264 1.8 mg/kg on day 1 of a 21-day cycle as a 30-min intravenous infusion for up to 1 year or until disease progression or unacceptable toxicity. The primary objective was overall response rate (ORR [complete response + partial response (PR)])...
May 19, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28526719/management-of-treatment-related-adverse-events-with-agents-targeting-the-mapk-pathway-in-patients-with-metastatic-melanoma
#5
Adil Daud, Katy Tsai
Tremendous progress has been made in the clinical landscape of advanced-stage BRAF V600-mutant melanoma treatment over the past 5 years. Targeted therapies that inhibit specific steps of the mitogen-activated protein kinase pathway have been shown to provide significant overall treatment benefit in patients with this difficult-to-treat disease. Combination therapy with BRAF and MEK inhibitors (dabrafenib plus trametinib or vemurafenib plus cobimetinib, respectively) has become standard of care. These agents are administered until disease progression or unacceptable toxicity occurs; thus, some patients may remain on maintenance therapy for an extended period of time, while toxicities may result in early discontinuation in other patients...
May 18, 2017: Oncologist
https://www.readbyqxmd.com/read/28524293/the-contribution-of-direct-patient-reported-adrs-to-drug-safety-signals-in-the-netherlands-from-2010-to-2015
#6
Florence van Hunsel, Susan de Waal, Linda Härmark
PURPOSE: The purpose of this study was to investigate the contribution of patient reports to signals sent by the Netherlands Pharmacovigilance Centre Lareb to the Dutch Medicines Evaluation Board and to determine if there are certain types of signals where patient report add a distinct contribution. METHOD: All signals from 2010 until 2015 were included. First, we investigated how many patient reports were present in the signals and the characteristics of these reports compared to the health care professional and marketing authorization holders' reports...
May 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28523596/pharmacokinetics-and-safety-of-vismodegib-in-patients-with-advanced-solid-malignancies-and-hepatic-impairment
#7
Ghassan K Abou-Alfa, Lionel D Lewis, Patricia LoRusso, Michael Maitland, Priya Chandra, Sravanthi Cheeti, Dawn Colburn, Sarah Williams, Brian Simmons, Richard A Graham
PURPOSE: Vismodegib is a Hedgehog pathway inhibitor approved for the treatment of advanced basal cell carcinoma. Currently, the pharmacokinetics (PK) and safety of vismodegib in patients with hepatic dysfunction are unknown and are the objective of this study. METHODS: Patients with advanced solid malignancies and hepatic impairment were enrolled into one of four cohorts: normal [bilirubin (bili) < upper limit of normal (ULN)], mild (ULN < bili ≤ 1...
May 18, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28522352/immune-plasma-for-the-treatment-of-severe-influenza-an-open-label-multicentre-phase-2-randomised-study
#8
John H Beigel, Pablo Tebas, Marie-Carmelle Elie-Turenne, Ednan Bajwa, Todd E Bell, Charles B Cairns, Shmuel Shoham, Jaime G Deville, Eric Feucht, Judith Feinberg, Thomas Luke, Kanakatte Raviprakash, Janine Danko, Dorothy O'Neil, Julia A Metcalf, Karen King, Timothy H Burgess, Evgenia Aga, H Clifford Lane, Michael D Hughes, Richard T Davey
BACKGROUND: Influenza causes substantial morbidity and mortality despite available treatments. Anecdotal reports suggest that plasma with high antibody titres to influenza might be of benefit in the treatment of severe influenza. METHODS: In this randomised, open-label, multicentre, phase 2 trial, 29 academic medical centres in the USA assessed the safety and efficacy of anti-influenza plasma with haemagglutination inhibition antibody titres of 1:80 or more to the infecting strain...
May 15, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28522338/year-round-influenza-immunisation-during-pregnancy-in-nepal-a-phase-4-randomised-placebo-controlled-trial
#9
Mark C Steinhoff, Joanne Katz, Janet A Englund, Subarna K Khatry, Laxman Shrestha, Jane Kuypers, Laveta Stewart, Luke C Mullany, Helen Y Chu, Steven C LeClerq, Naoko Kozuki, Monica McNeal, Adriana M Reedy, James M Tielsch
BACKGROUND: Influenza immunisation during pregnancy is recommended but not widely implemented in some low-income regions. We assessed the safety and efficacy in mothers and infants of year-round maternal influenza immunisation in Nepal, where influenza viruses circulate throughout the year. METHODS: In this phase 4, randomised, placebo-controlled trial, we enrolled two consecutive sequential annual cohorts of pregnant women from the Sarlahi district in southern Nepal...
May 15, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28522181/safety-and-efficacy-of-edaravone-in-well-defined-patients-with-amyotrophic-lateral-sclerosis-a-randomised-double-blind-placebo-controlled-trial
#10
(no author information available yet)
BACKGROUND: In a previous phase 3 study in patients with amyotrophic lateral sclerosis (ALS), edaravone did not show a significant difference in the Revised ALS Functional Rating Scale (ALSFRS-R) score compared with placebo. Post-hoc analysis of these data revealed that patients in an early stage with definite or probable diagnosis of ALS, defined by the revised El Escorial criteria, who met a select set of inclusion criteria showed a greater magnitude of effect than did the full study population...
May 15, 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28521199/safety-profile-of-injectable-hydromorphone-and-diacetylmorphine-for-long-term-severe-opioid-use-disorder
#11
Eugenia Oviedo-Joekes, Suzanne Brissette, Scott MacDonald, Daphne Guh, Kirsten Marchand, Salima Jutha, Scott Harrison, Amin Janmohamed, Derek Z Zhang, Aslam H Anis, Michael Krausz, David C Marsh, Martin T Schechter
AIMS: To review the safety profile of injectable hydromorphone and diacetylmorphine and explore if adverse events (AEs) or serious adverse events (SAEs) were associated with dose and patterns of attendance. METHODS: This was a non-inferiority randomized double-blind controlled trial (Vancouver, Canada) testing hydromorphone (n=100) and diacetylmorphine (n=102) for the treatment of severe opioid use disorder. Medications were delivered under the supervision of trained Registered Nurses up to three times daily...
May 10, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/28516890/tocilizumab-in-the-treatment-of-patients-with-rheumatoid-arthritis-in-real-clinical-practice-results-of-an-italian-observational-study
#12
Roberto Caporali, Luca Idolazzi, Stefano Bombardieri, Gianfranco Ferraccioli, Roberto Gerli, Marco Govoni, Marco Matucci Cerinic, Giovanni Pomponio, Fausto Salaffi, Rossella Tirri, Francesca Benaglio, Laura Bianchino, Piercarlo Sarzi-Puttini
OBJECTIVES: To describe the effectiveness and safety of tocilizumab (TCZ), an interleukin-6 receptor inhibitor, in a cohort of patients with rheumatoid arthritis (RA) recruited in clinical practice. METHODS: TRUST was an observational study in RA patients who started treatment with TCZ in the 6 months prior to site activation and were still on treatment at start of study; patients were followed up to 12 months after the first TCZ infusion. RESULTS: 322 RA patients were enrolled in 59 Italian centres (mean age: 55...
May 8, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28516874/long-term-effects-of-interleukin-17a-inhibition-with-secukinumab-in-active-ankylosing-spondylitis-3-year-efficacy-and-safety-results-from-an-extension-of-the-phase-3-measure-1-trial
#13
Xenofon Baraliakos, Alan J Kivitz, Atul A Deodhar, Jürgen Braun, James C Wei, Eumorphia Maria Delicha, Zsolt Talloczy, Brian Porter
OBJECTIVES: Secukinumab, a fully human anti-IL-17A monoclonal antibody, provided rapid and sustained improvements in signs and symptoms of ankylosing spondylitis (AS) over 2 years in the Phase 3 MEASURE 1 trial. Here, we report efficacy and safety after 3 years of treatment. METHODS: AS subjects completing 2 years of treatment every 4 weeks with subcutaneous secukinumab 150 or 75 mg (following intravenous loading or initial placebo treatment to 16/24 weeks) entered a separate 3-year extension study (NCT01863732)...
May 15, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28514508/methadone-for-neuropathic-pain-in-adults
#14
REVIEW
Ewan D McNicol, McKenzie C Ferguson, Roman Schumann
BACKGROUND: This review replaces an earlier review, "Methadone for chronic non-cancer pain in adults". This review serves to update the original and includes only studies of neuropathic pain. Methadone belongs to a class of analgesics known as opioids, that are considered the cornerstone of therapy for moderate-to-severe postsurgical pain and pain due to life-threatening illnesses; however, their use in neuropathic pain is controversial. Methadone has many characteristics that differentiate it from other opioids, which suggests that it may have a different efficacy and safety profile...
May 17, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28512072/lessons-learnt-in-japan-from-adverse-reactions-to-the-hpv-vaccine-a-medical-ethics-perspective
#15
Hirokuni Beppu, Masumi Minaguchi, Kiyoshi Uchide, Kunihiko Kumamoto, Masato Sekiguchi, Yukari Yaju
The human papillomavirus (HPV) vaccine has been linked to a number of serious adverse reactions. The range of symptoms is diverse and they develop in a multi-layered manner over an extended period of time. The argument for the safety and effectiveness of the HPV vaccine overlooks the following flaws: (i) no consideration is given to the genetic basis of autoimmune diseases, and arguments that do not take this into account cannot assure the safety of the vaccine; (ii) the immune evasion mechanisms of HPV, which require the HPV vaccine to maintain an extraordinarily high antibody level for a long period of time for it to be effective, are disregarded; and (iii) the limitations of effectiveness of the vaccine...
April 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28510574/dose-of-antivenom-for-the-treatment-of-snakebite-with-neurotoxic-envenoming-evidence-from-a-randomised-controlled-trial-in-nepal
#16
Emilie Alirol, Sanjib Kumar Sharma, Anup Ghimire, Antoine Poncet, Christophe Combescure, Chabilal Thapa, Vijaya Prasad Paudel, Kalidas Adhikary, Walter Robert Taylor, David Warrell, Ulrich Kuch, François Chappuis
BACKGROUND: Currently, there is inadequate evidence on which to base clinical management of neurotoxic snakebite envenoming, especially in the choice of initial antivenom dosage. This randomised controlled trial compared the effectiveness and safety of high versus low initial antivenom dosage in victims of neurotoxic envenoming. METHODOLOGY/ PRINCIPAL FINDINGS: This was a balanced, randomised, double-blind trial that was conducted in three health care centers located in the Terai plains of Nepal...
May 16, 2017: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/28510296/pharmacokinetics-and-safety-of-single-dose-inhaled-loxapine-in-children-and-adolescents
#17
Sally Selim, Robert Riesenberg, James Cassella, Jeevan Kunta, Edward Hellriegel, Mark A Smith, Alexander A Vinks, Laura Rabinovich-Guilatt
This multisite open-label study sought to characterize the pharmacokinetics and safety of a single dose of inhaled loxapine in children and adolescents. Loxapine powder for oral inhalation was administered via a single-use handheld drug device to children and adolescents (aged 10-17 years) with any condition warranting chronic antipsychotic use. Patients were dosed according to body weight and cohort (<50 kg [n = 15], 2.5 or 5 mg; ≥50 kg [n = 15], 5 or 10 mg); the first 6 patients (cohort 1) enrolled in each weight group received the lower dose...
May 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28508983/effect-of-tolvaptan-in-a-patient-with-autosomal-dominant-polycystic-kidney-disease-after-living-donor-liver-transplantation
#18
Kiyotaka Uchiyama, Kazuya Honda, Ryochi Yoshida, Yuka Kamijo, Mai Yanagi, Mineo Nakatsuka, Yoshitaka Ishibashi
Recently, a large randomized placebo-controlled trial indicated a beneficial effect of tolvaptan on the progression of autosomal dominant polycystic kidney disease (ADPKD) with near-normal kidney function. Meanwhile, the evidence of tolvaptan's efficacy in ADPKD with severe renal insufficiency was limited and higher frequency of liver enzyme elevations were observed in patients taking tolvaptan. Liver transplantation (LT) is the only curative treatment for patients with severe polycystic liver disease associated with ADPKD, but considering that liver injuries should be avoided particularly in patients who underwent LT, we must be careful to start tolvaptan in post-LT ADPKD patients...
November 2016: CEN Case Reports
https://www.readbyqxmd.com/read/28508936/phase-i-clinical-study-of-zyan1-a-novel-prolyl-hydroxylase-phd-inhibitor-to-evaluate-the-safety-tolerability-and-pharmacokinetics-following-oral-administration-in-healthy-volunteers
#19
Kevinkumar A Kansagra, Deven Parmar, Rajendra H Jani, Nuggehally R Srinivas, Jason Lickliter, Harilal V Patel, Devang P Parikh, Heather Heading, Hardik B Patel, Rahul J Gupta, Chintan Y Shah, Maulik R Patel, Vyom N Dholakia, Raghav Sukhadiya, Mukul R Jain, Krupi V Parmar, Kinjal Barot
OBJECTIVE: This phase I study of ZYAN1 was conducted to evaluate the safety, tolerability, and pharmacokinetics following oral administration in healthy volunteers. METHODS: The study was a randomized, double-blind, placebo-controlled phase I study carried out in two parts in addition to a third part involving an open-label study to evaluate the food/sex effect. A total of 100 subjects were enrolled into the study as follows: part I-single-dose study with ZYAN1 10, 25, 50, 100, 150, 200, and 300 mg (n = 56); part II-multiple-dose study with every other day dosing of ZYAN1 100, 150, 200, and 300 mg (n = 32); and part III-sex and food effect study with ZYAN1 150 mg (n = 12; open-label)...
May 16, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28507605/diclofenac-potassium-for-oral-solution-cambia-%C3%A2-in-the-acute-management-of-a-migraine-attack-clinical-evidence-and-practical-experience
#20
REVIEW
Shivang Joshi, Alan M Rapoport
Migraine headache affects about 12% of Western populations and is the third most common disease worldwide (sixth in terms of disability). In 1993, triptans were introduced in the United States as a new treatment for managing migraine attacks, but their use is limited by lack of response and safety concerns in some patients. Treatment options for patients with migraine who fail or cannot tolerate triptans include switching to another medication or adding an adjunctive medication. Desirable characteristics reported by patients for acute treatment of migraine attacks include complete pain relief, fast onset of action, and no pain recurrence...
April 2017: Therapeutic Advances in Neurological Disorders
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