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https://www.readbyqxmd.com/read/28653571/chimeric-antigen-receptor-t-cells-for-the-treatment-of-cancer-and-the-future-of-preclinical-models-for-predicting-their-toxicities
#1
Anja Wegner
Chimeric antigen receptor T-cell therapy has achieved highly promising results in clinical trials, particularly in B-cell malignancies. However, reports of serious adverse events including a number of patient deaths have raised concerns about safety of this treatment. Presently available preclinical models are not designed for predicting toxicities seen in human patients. Besides choosing the right animal model, careful considerations must be taken in chimeric antigen receptor T-cell design and the amount of T cells infused...
June 2017: Immunotherapy
https://www.readbyqxmd.com/read/28653440/treatment-of-breast-cancer-related-lymphedema-with-adipose-derived-regenerative-cells-and-fat-grafts-a-feasibility-and-safety-study
#2
Navid Mohamadpour Toyserkani, Charlotte Harken Jensen, Ditte Caroline Andersen, Søren Paludan Sheikh, Jens Ahm Sørensen
Breast cancer-related lymphedema (BCRL) is a debilitating late complication with a lack of treatment opportunities. Recent studies have suggested that mesenchymal stromal cells can alleviate lymphedema. Herein, we report the results from the first human pilot study with freshly isolated adipose-derived regenerative cells (ADRC) for treating lymphedema with 6 months follow-up. Ten BCRL patients were included. ADRC was injected directly into the axillary region, which was combined with a scar-releasing fat graft procedure...
June 27, 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28653251/suggestion-of-added-value-by-bevacizumab-to-chemotherapy-in-patients-with-unresectable-or-recurrent-small-bowel-cancer
#3
Kotoe Takayoshi, Hitoshi Kusaba, Masato Uenomachi, Kenji Mitsugi, Chinatsu Makiyama, Akitaka Makiyama, Keita Uchino, Tsuyoshi Shirakawa, Yoshihiro Shibata, Yudai Shinohara, Kyoko Inadomi, Kenji Tsuchihashi, Shuji Arita, Hiroshi Ariyama, Taito Esaki, Koichi Akashi, Eishi Baba
PURPOSE: Standard therapy for advanced small bowel adenocarcinoma (SBA) has not yet been established. The present study assessed the efficacy and safety of chemotherapy (CT) in association with molecular targeting approaches for SBA. METHODS: The histories of 33 advanced SBA patients from six different institutions in Japan, who received CT from 2008 to 2016, were retrospectively examined for background, clinical course and outcome. RESULTS: Median patient age was 65 years (range 39-83)...
June 26, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28652529/efficacy-and-safety-of-cholesteryl-ester-transfer-protein-inhibitor-evacetrapib-administered-as-monotherapy-in-japanese-patients-with-primary-hypercholesterolemia
#4
Tamio Teramoto, Arihiro Kiyosue, Takeshi Iimura, Yasushi Takita, Jeffrey S Riesmeyer, Masahiro Murakami
BACKGROUND: Inhibition of cholesteryl ester transfer protein with evacetrapib may provide an additional treatment option for patients who do not reach their low-density lipoprotein cholesterol (LDL-C) goal with statins or patients who cannot tolerate statins.Methods and Results:This multicenter, randomized, 12-week, double-blind, parallel group, placebo-controlled, outpatient, phase 3 study evaluated the efficacy of evacetrapib in reducing LDL-C in 54 Japanese patients (27 evacetrapib, 27 placebo) with primary hypercholesterolemia...
June 23, 2017: Circulation Journal: Official Journal of the Japanese Circulation Society
https://www.readbyqxmd.com/read/28652196/efficacy-of-e-coli-derived-rhbmp-2-in-posterolateral-lumbar-fusion-an-open-active-controlled-randomized-multicenter-trial
#5
Jae Hwan Cho, Jae Hyup Lee, Jin Sup Yeom, Bong-Soon Chang, Jae Jun Yang, Ki Hyoung Koo, Chang Ju Hwang, Kwang Bok Lee, Ho-Joong Kim, Choon-Ki Lee, Hyoungmin Kim, Kyung-Soo Suk, Woo Dong Nam, Jumi Han
BACKGROUND CONTEXT: The efficacy and safety of recombinant human bone morphogenetic protein-2 as a bone graft substitute in spinal fusion has been widely researched. However, no study of the efficacy and safety of E.coli-derived rhBMP-2 (E.BMP-2) with a hydroxyapatite (HA) carrier has been proposed. PURPOSE: To compare the efficacy and safety of fusion materials between E.BMP-2 and autogenous iliac bone graft in posterolateral fusion (PLF). STUDY DESIGN/SETTING: Open, active-controlled, randomized, multicenter trial PATIENT SAMPLE: This study included 93 patients who underwent single-level lumbar or lumbosacral PLF...
June 23, 2017: Spine Journal: Official Journal of the North American Spine Society
https://www.readbyqxmd.com/read/28651927/doxorubicin-plus-evofosfamide-versus-doxorubicin-alone-in-locally-advanced-unresectable-or-metastatic-soft-tissue-sarcoma-th-cr-406-sarc021-an-international-multicentre-open-label-randomised-phase-3-trial
#6
William D Tap, Zsuzsanna Papai, Brian A Van Tine, Steven Attia, Kristen N Ganjoo, Robin L Jones, Scott Schuetze, Damon Reed, Sant P Chawla, Richard F Riedel, Anders Krarup-Hansen, Maud Toulmonde, Isabelle Ray-Coquard, Peter Hohenberger, Giovanni Grignani, Lee D Cranmer, Scott Okuno, Mark Agulnik, William Read, Christopher W Ryan, Thierry Alcindor, Xavier F Garcia Del Muro, G Thomas Budd, Hussein Tawbi, Tillman Pearce, Stew Kroll, Denise K Reinke, Patrick Schöffski
BACKGROUND: Evofosfamide is a hypoxia-activated prodrug of bromo-isophosphoramide mustard. We aimed to assess the benefit of adding evofosfamide to doxorubicin as first-line therapy for advanced soft-tissue sarcomas. METHODS: We did this international, open-label, randomised, phase 3, multicentre trial (TH CR-406/SARC021) at 81 academic or community investigational sites in 13 countries. Eligible patients were aged 15 years or older with a diagnosis of an advanced unresectable or metastatic soft-tissue sarcoma, of intermediate or high grade, for which no standard curative therapy was available, an Eastern Cooperative Oncology Group performance status of 0-1, and measurable disease by Response Evaluation Criteria in Solid Tumors version 1...
June 23, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28651829/evaluation-of-a-12-week-targeted-vitamin-d-supplementation-regimen-in-patients-with-active-inflammatory-bowel-disease
#7
Mayur Garg, Ourania Rosella, Gennaro Rosella, Yunqiu Wu, John S Lubel, Peter R Gibson
BACKGROUND & AIMS: Vitamin D at serum 25(OH)D concentrations above 100 nmol/L is associated with disease remission in patients with IBD, suggesting targeted dosing might be anti-inflammatory. This study aimed to assess the effectiveness, safety and predictors of a 12-week regimen of vitamin D supplementation to achieve such a target in patients with active disease. METHODS: In a pilot study, patients with active colitis and a serum 25(OH)D concentration <75 nmol/L were prescribed oral liquid vitamin D supplementation over 12 weeks using a specific protocol with dose adjusted 4-weekly to aim for a target level of 100-125 nmol/L...
June 15, 2017: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
https://www.readbyqxmd.com/read/28651642/a-pilot-randomized-controlled-trial-of-acupuncture-at-the-si-guan-xue-for-cancer-pain
#8
To-Yi Lam, Li-Ming Lu, Wai-Man Ling, Li-Zhu Lin
BACKGROUND: Pain is a common symptom in cancer patients. Acupuncture is a suggested treatment for a wide range of clinical conditions, usually for its beneficial effects on pain control. Si guan xue (the four points) have been widely used in clinical practice, and has shown that it is highly effective, effective in obtaining qi, shows strong acupuncture stimulation, and is simple to manipulate and safe to use. Therefore, the aim of this study is to test the protocol and safety of acupuncture at the si guan xue in the management of cancer pain...
June 26, 2017: BMC Complementary and Alternative Medicine
https://www.readbyqxmd.com/read/28650713/occupational-chemical-exposures-a-collaboration-between-the-georgia-poison-center-and-the-occupational-safety-and-health-administration
#9
Aaron W Tustin, Alison Jones, Gaylord P Lopez, Glenn R Ketcham, Michael J Hodgson
CONTEXT: In the United States, regional poison centers frequently receive calls about toxic workplace exposures. Most poison centers do not share call details routinely with governmental regulatory agencies. Worker health and safety could be enhanced if regulators such as the Occupational Safety and Health Administration (OSHA) had the ability to investigate these events and prevent similar incidents. With this goal in mind, the Georgia Poison Center (GPC) began referring occupational exposures to OSHA in July 2014...
June 26, 2017: Clinical Toxicology
https://www.readbyqxmd.com/read/28648803/sorafenib-in-combination-with-transarterial-chemoembolisation-in-patients-with-unresectable-hepatocellular-carcinoma-tace-2-a-randomised-placebo-controlled-double-blind-phase-3-trial
#10
Tim Meyer, Richard Fox, Yuk Ting Ma, Paul J Ross, Martin W James, Richard Sturgess, Clive Stubbs, Deborah D Stocken, Lucy Wall, Anthony Watkinson, Nigel Hacking, T R Jeffry Evans, Peter Collins, Richard A Hubner, David Cunningham, John Neil Primrose, Philip J Johnson, Daniel H Palmer
BACKGROUND: Transarterial chemoembolisation (TACE) is the standard of care for patients with intermediate stage hepatocellular carcinoma, while the multikinase inhibitor sorafenib improves survival in patients with advanced disease. We aimed to determine whether TACE with sorafenib improves progression-free survival versus TACE with placebo. METHODS: We did a multicentre, randomised, placebo-controlled, phase 3 trial (TACE 2) in 20 hospitals in the UK for patients with unresectable, liver-confined hepatocellular carcinoma...
June 22, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28648618/patients-preference-of-trastuzumab-administration-subcutaneous-versus-intravenous-in-her2-positive-metastatic-breast-cancer-results-of-the-randomised-metaspher-study
#11
X Pivot, J P Spano, M Espie, P Cottu, C Jouannaud, V Pottier, L Moreau, J M Extra, A Lortholary, P Rivera, D Spaeth, H Attar-Rabia, C Benkanoun, L Dima-Martinez, N Esposito, J Gligorov
HannaH (NCT00950300) and PrefHer (NCT01401166) studies validated the subcutaneous (H-s.c.) formulation of trastuzumab as effective and safe as intravenous (H-i.v.) and highly preferred by patients in early breast cancer. The present randomised MetaspHer trial (NCT01810393) is the first study assessing patient's preference in metastatic setting. METHODS: Patients with HER2-positive metastatic breast cancer who completed a first line chemotherapy with trastuzumab and achieved a long-term response lasting more than 3 years were randomised to receive 3 cycles of 600-mg fixed-dose adjuvant H-s...
June 22, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28648402/guided-graded-exercise-self-help-plus-specialist-medical-care-versus-specialist-medical-care-alone-for-chronic-fatigue-syndrome-getset-a-pragmatic-randomised-controlled-trial
#12
Lucy V Clark, Francesca Pesola, Janice M Thomas, Mario Vergara-Williamson, Michelle Beynon, Peter D White
BACKGROUND: Graded exercise therapy is an effective and safe treatment for chronic fatigue syndrome, but it is therapist intensive and availability is limited. We aimed to test the efficacy and safety of graded exercise delivered as guided self-help. METHODS: In this pragmatic randomised controlled trial, we recruited adult patients (18 years and older) who met the UK National Institute for Health and Care Excellence criteria for chronic fatigue syndrome from two secondary-care clinics in the UK...
June 22, 2017: Lancet
https://www.readbyqxmd.com/read/28645995/mepolizumab-for-the-treatment-of-severe-eosinophilic-asthma
#13
REVIEW
Mara N Poulakos, Shawna M Cargill, Melissa F Waineo, Allen L Wolford
PURPOSE: Published data on the pharmacology, pharmacokinetics and pharmacodynamics, and clinical efficacy and safety of the interleukin-5 antagonist mepolizumab are reviewed. SUMMARY: Asthma of the eosinophilic phenotype is characterized by persistent eosinophilic airway inflammation promoted primarily by T-helper type 2 cytokines, the key regulator of eosinophils. Patients with severe eosinophilic asthma are burdened by the need to administer high doses of corticosteroids to help manage their symptoms...
July 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28645853/anterior-pallidal-deep-brain-stimulation-for-tourette-s-syndrome-a-randomised-double-blind-controlled-trial
#14
Marie-Laure Welter, Jean-Luc Houeto, Stéphane Thobois, Benoit Bataille, Marc Guenot, Yulia Worbe, Andreas Hartmann, Virginie Czernecki, Eric Bardinet, Jerome Yelnik, Sophie Tezenas du Montcel, Yves Agid, Marie Vidailhet, Philippe Cornu, Audrey Tanguy, Solène Ansquer, Nematollah Jaafari, Emmanuel Poulet, Giulia Serra, Pierre Burbaud, Emmanuel Cuny, Bruno Aouizerate, Pierre Pollak, Stephan Chabardes, Mircea Polosan, Michel Borg, Denys Fontaine, Bruno Giordana, Sylvie Raoul, Tiphaine Rouaud, Anne Sauvaget, Isabelle Jalenques, Carine Karachi, Luc Mallet
BACKGROUND: Deep brain stimulation (DBS) has been proposed to treat patients with severe Tourette's syndrome, and open-label trials and two small double-blind trials have tested DBS of the posterior and the anterior internal globus pallidus (aGPi). We aimed to specifically assess the efficacy of aGPi DBS for severe Tourette's syndrome. METHODS: In this randomised, double-blind, controlled trial, we recruited patients aged 18-60 years with severe and medically refractory Tourette's syndrome from eight hospitals specialised in movement disorders in France...
June 20, 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28645776/selective-inhibition-of-flt3-by-gilteritinib-in-relapsed-or-refractory-acute-myeloid-leukaemia-a-multicentre-first-in-human-open-label-phase-1-2-study
#15
Alexander E Perl, Jessica K Altman, Jorge Cortes, Catherine Smith, Mark Litzow, Maria R Baer, David Claxton, Harry P Erba, Stan Gill, Stuart Goldberg, Joseph G Jurcic, Richard A Larson, Chaofeng Liu, Ellen Ritchie, Gary Schiller, Alexander I Spira, Stephen A Strickland, Raoul Tibes, Celalettin Ustun, Eunice S Wang, Robert Stuart, Christoph Röllig, Andreas Neubauer, Giovanni Martinelli, Erkut Bahceci, Mark Levis
BACKGROUND: Internal tandem duplication mutations in FLT3 are common in acute myeloid leukaemia and are associated with rapid relapse and short overall survival. The clinical benefit of FLT3 inhibitors in patients with acute myeloid leukaemia has been limited by rapid generation of resistance mutations, particularly in codon Asp835 (D835). We aimed to assess the highly selective oral FLT3 inhibitor gilteritinib in patients with relapsed or refractory acute myeloid leukaemia. METHODS: In this phase 1-2 trial, we enrolled patients aged 18 years or older with acute myeloid leukaemia who either were refractory to induction therapy or had relapsed after achieving remission with previous treatment...
June 20, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28645740/safety-of-the-2d-3d-direct-acting-antiviral-regimen-in-hcv-induced-child-pugh-a-cirrhosis-a-pooled-analysis
#16
Fred Poordad, David R Nelson, Jordan J Feld, Michael W Fried, Heiner Wedemeyer, Lois Larsen, Daniel E Cohen, Eric Cohen, Niloufar Mobashery, Fernando Tatsch, Graham R Foster
BACKGROUND & AIMS: Chronic hepatitis C virus (HCV)-infected patients with cirrhosis are a high-priority population for treatment. To help inform the benefit-risk profile of the all-oral direct-acting antiviral (DAA) combination regimen of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir (OBV/PTV/r ± DSV) in patients with Child-Pugh A cirrhosis, we undertook a comprehensive review of AbbVie-sponsored clinical trials enrolling patients with Child-Pugh A cirrhosis. METHODS: Twelve phase II or III clinical trials of the 2-DAA regimen of OBV/PTV/r ± ribavirin (RBV) or the 3-DAA regimen of OBV/PTV/r + DSV ± RBV that included patients with Child-Pugh A cirrhosis were reviewed; patients who completed treatment by November 16, 2015 were included in a pooled, post hoc safety assessment...
June 20, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28645737/alfapump-system-vs-large-volume-paracentesis-for-refractory-ascites-a-multicenter-randomized-controlled-study
#17
Christophe Bureau, Danielle Adebayo, Mael Chalret de Rieu, Laure Elkrief, Dominique Valla, Markus Peck-Radosavljevic, Anne McCune, Victor Vargas, Macarena Simon-Talero, Juan Cordoba, Paolo Angeli, Silvia Rosi, Stewart MacDonald, Massimo Malago, Maria Stepanova, Zobair M Younossi, Claudia Trepte, Randall Watson, Oleg Borisenko, Sun Sun, Neil Inhaber, Rajiv Jalan
BACKGROUND AND AIMS: Patients with refractory ascites (RA) require repeated large volume paracenteses (LVP), which involves frequent hospital visits and is associated with poor quality-of-life. This study assessed safety and efficacy of an automated, low-flow pump (alfapump [AP]) compared with LVP [SoC]. METHODS: Randomized, controlled trial, in 7 centers, with 6M patient observation. Primary outcome was time to first LVP. Secondary outcomes included paracentesis requirement, safety, health-related quality-of-life (HRQoL), and survival...
June 20, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28644733/trends-of-atv-use-and-associated-injury-on-saskatchewan-farms
#18
Lynne Clay, Stephan Milosavljevic, Niels Koehncke, James Dosman, Catherine Trask
PURPOSE: All-terrain vehicles (ATV's) are a hazardous source of injury in many contexts and geographical regions, but to date have not been investigated in Saskatchewan. METHODS: Baseline surveys from the Saskatchewan Farm Injury Project were examined at two time points in terms of: 1) rates and correlated characteristics of reported ATV use; and 2) qualitative content analysis of injury events involving ATVs. The sample of eligible farmers was 2972 in 2007 and 1702 in 2013...
June 23, 2017: Journal of Occupational and Environmental Hygiene
https://www.readbyqxmd.com/read/28644367/oral-cholic-acid-is-efficacious-and-well-tolerated-in-patients-with-bile-acid-synthesis-and-zellweger-spectrum-disorders
#19
James E Heubi, Kevin E Bove, Kenneth D R Setchell
BACKGROUND/AIMS: Patients with bile acid synthesis disorders (BASD) due to single enzyme defects (SED) or Zellweger spectrum disorders (ZSD) accumulate hepatotoxic atypical bile acids resulting in potentially fatal progressive liver disease. We evaluated the efficacy and safety of oral cholic acid in patients with BASD. METHODS: In this phase 3, open-label, single-arm, nonrandomized, noncomparative study conducted over 18 years, patients were administered cholic acid orally 10 to 15 mg/kg/day...
June 21, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28644298/omission-of-high-alert-medications-a-hidden-danger
#20
Matthew C Grissinger
The Pennsylvania Patient Safety Reporting System is a confidential, statewide Internet reporting system to which all Pennsylvania hospitals, outpatient-surgery facilities, birthing centers, and abortion facilities must file information on incidents and serious events.Safety Monitor is a column from Pennsylvania's Patient Safety Authority, the authority that informs nurses on issues that can affect patient safety and presents strategies they can easily integrate into practice. For more information on the authority, visit www...
July 2017: American Journal of Nursing
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