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serious adverse event

Paul Gillard, Tsuyoshi Tamura, Haruo Kuroki, Yoshiyuki Morikawa, Leentje Moerman, Jose Parra, Yurina Kitamura, Kazuko Mihara, Arisa Okamasa
Rotavirus infections have been reported to account for 40-50% of all hospitalized acute gastroenteritis cases in young children (<5 years) in Japan. Since 2011, Rotarix containing the live attenuated human rotavirus RIX4414 strain (HRV) has been licensed in Japan for infants. Vaccination against rotavirus is optional in Japan whereas administration of diphtheria, pertussis, tetanus, and inactivated poliovirus (DPT-IPV) vaccine is part of the national routine immunization program. In this open-label, randomized, controlled, multicenter study, we evaluated the immunogenicity and safety of the DPT-IPV vaccine (Squarekids) administered concomitantly or staggered with the liquid HRV (Rotarix) vaccine in healthy Japanese infants...
February 20, 2019: Human Vaccines & Immunotherapeutics
(no author information available yet)
In many countries, a second dose of a combined measles, mumps, and rubella (MMR) vaccine is recommended at 4-6 years of age - similarly to the booster of diphtheria, tetanus, acellular pertussis, and inactivated polio vaccine (DTaP-IPV) and the second dose of varicella vaccine (VV). Vaccine co-administration is generally encouraged if no interferences exist among the vaccines. This phase IIIa, randomized, controlled trial (NCT01621802) evaluated the immunogenicity and safety of MMR-RIT (Priorix, GSK) when given as a second dose with or without co-administration of DTaP-IPV and VV, using MMR II (M-M-R II, Merck & Co Inc...
February 20, 2019: Human Vaccines & Immunotherapeutics
Katrine Melby, Rolf W Gråwe, Trond O Aamo, Øyvind Salvesen, Olav Spigset
BACKGROUND: In a pilot study, intranasal oxytocin was demonstrated to reduce the benzodiazepine dose needed to relieve withdrawal symptoms during alcohol detoxification. The aim of the present study was to compare the effect of oxytocin and placebo during a three-day period of alcohol detoxification at an addiction treatment center in Norway. METHODS: Randomized, double-blind, placebo-controlled trial with 40 patients fulfilling criteria for ICD-10 diagnosis of alcohol dependence (F10...
February 13, 2019: Drug and Alcohol Dependence
Masayoshi Harigai, Tsutomu Takeuchi, Josef S Smolen, Kevin L Winthrop, Atsushi Nishikawa, Terence P Rooney, Chadi G Saifan, Maher Issa, Yoshitaka Isaka, Naotsugu Akashi, Taeko Ishii, Yoshiya Tanaka
OBJECTIVES: Baricitinib is a selective oral inhibitor of JAK1/JAK2 for patients with moderately-to-severely active rheumatoid arthritis (RA). Baricitinib's safety profile in Japanese patients was evaluated using 6 studies (5 Ph2/Ph3 trials, 1 long-term extension study thru 01-Sept-2016) from an integrated database (9 RA studies). METHODS: Incidence rates (IRs) or exposure-adjusted IRs (EAIRs) of adverse events (AEs) per 100 patient-years (PY) were calculated using data which included RA patients exposed to any baricitinib dose...
February 20, 2019: Modern Rheumatology
Alison Haywood, Jacqueline Duc, Phillip Good, Sohil Khan, Kirsty Rickett, Petra Vayne-Bossert, Janet R Hardy
BACKGROUND: Dyspnoea is a common symptom in advanced cancer, with a prevalence of up to 70% among patients at end of life. The cause of dyspnoea is often multifactorial, and may cause considerable psychological distress and suffering. Dyspnoea is often undertreated and good symptom control is less frequently achieved in people with dyspnoea than in people with other symptoms of advanced cancer, such as pain and nausea. The exact mechanism of action of corticosteroids in managing dyspnoea is unclear, yet corticosteroids are commonly used in palliative care for a variety of non-specific indications, including pain, nausea, anorexia, fatigue and low mood, despite being associated with a wide range of adverse effects...
February 20, 2019: Cochrane Database of Systematic Reviews
Thomas R Fanshawe, Jamie Hartmann-Boyce, Rafael Perera, Nicola Lindson
BACKGROUND: Competitions might encourage people to undertake and/or reinforce behaviour change, including smoking cessation. Competitions involve individuals or groups having the opportunity to win a prize following successful cessation, either through direct competition or by entry into a lottery or raffle. OBJECTIVES: To determine whether competitions lead to higher long-term smoking quit rates. We also aimed to examine the impact on the population, the costs, and the unintended consequences of smoking cessation competitions...
February 20, 2019: Cochrane Database of Systematic Reviews
Anna-Marie Hosking, Margit Juhász, Natasha Atanaskova Mesinkovska
Systemic administration of Janus kinase inhibitors (JAKis) is associated with adverse events, including serious infections, malignancy, and herpes zoster (HZ). Herein, we report a case of a 17-year-old male with alopecia universalis who developed suspected HZ-associated encephalitis (HZAE) during treatment with oral tofacitinib. Oral tofacitinib was immediately discontinued, and the patient was started on antiviral treatment. We present this case to highlight a serious complication that can arise with oral JAKi therapy...
November 2018: International Journal of Trichology
Tigran Makunts, Isaac V Cohen, Linda Awdishu, Ruben Abagyan
Proton pump inhibitors, PPIs, are widely prescribed and sold globally. Although initially intended for time-limited treatment of acute disorders, such as gastric ulcers and esophagitis, PPIs are now commonly used for prolonged durations and are considered safe for over the counter access. Recent studies have raised concern over associations between PPI use and acute kidney injury, chronic kidney disease, end-stage renal disease, and electrolyte abnormalities. The growing concern over potentially serious adverse drug reactions warrants an evaluation of post marketing surveillance data...
February 19, 2019: Scientific Reports
J J Tonison, S G Fischer, M Viehrig, S Welz, S Boeke, K Zwirner, B Klumpp, L H Braun, D Zips, C Gani
Radiation pneumonitis (RP) is a serious complication that can occur after thoracic radiotherapy. The goal of this study is to investigate the incidence of RP after radiochemotherapy with intensity modulated radiotherapy (IMRT) in patients with esophageal cancer and correlate this with dose volume histogram (DVH) related parameters. For this purpose, the clinical course of 73 patients was evaluated and irradiation doses to the lungs were extracted from radiotherapy treatment plans. Furthermore, a systematic review on this topic was conducted across PubMed...
February 19, 2019: Scientific Reports
Marija Barbateskovic, Sara Russo Krauss, Marie Oxenboell Collet, Laura Krone Larsen, Janus Christian Jakobsen, Anders Perner, Jørn Wetterslev
OBJECTIVES: We assessed the evidence from reviews and meta-analyses of randomised clinical trials on the effects of pharmacological prevention and management of delirium in intensive care unit (ICU) patients. METHODS: We searched for reviews in July 2017 in: Cochrane Library, MEDLINE, Embase, Science Citation Index, BIOSIS Previews, CINAHL and LILACS. We assessed whether reviews were systematic according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and assessed the methodological quality using ROBIS...
February 19, 2019: BMJ Open
Suzanne Hagen, Doreen McClurg, Carol Bugge, Jean Hay-Smith, Sarah Gerard Dean, Andrew Elders, Cathryn Glazener, Mohamed Abdel-Fattah, Wael Ibrahim Agur, Jo Booth, Karen Guerrero, John Norrie, Mary Kilonzo, Gladys McPherson, Alison McDonald, Susan Stratton, Nicole Sergenson, Aileen Grant, Lyndsay Wilson
INTRODUCTION: Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this...
February 19, 2019: BMJ Open
Jane Lockstone, Ianthe Boden, Iain K Robertson, David Story, Linda Denehy, Selina M Parry
INTRODUCTION: Postoperative pulmonary complications (PPCs) are a common serious complication following upper abdominal surgery leading to significant consequences including increased mortality, hospital costs and prolonged hospitalisation. The primary objective of this study is to detect whether there is a possible signal towards PPC reduction with the use of additional intermittent non-invasive ventilation (NIV) compared with continuous high-flow nasal oxygen therapy alone following high-risk elective upper abdominal surgery...
January 9, 2019: BMJ Open
Lai Wei, Hiromitsu Kumada, Ponni V Perumalswami, Tawesak Tanwandee, Wendy Cheng, Jeong Heo, Pin-Nan Cheng, Peggy Hwang, Sheng Mei Mu, Xu Min Zhao, Ernest Asante-Appiah, Luzelena Caro, George J Hanna, Michael N Robertson, Barbara A Haber, Rohit Talwani
BACKGROUND AND AIM: Estimates suggest that in Asia more than 31 million individuals have hepatitis C virus infection. The present analysis was conducted to assess the efficacy and safety of elbasvir/grazoprevir in Asian participants enrolled in the elbasvir/grazoprevir phase 2/3 clinical trials. METHODS: This is an integrated analysis of data from 12 international phase 2/3 clinical trials. Asian participants with chronic hepatitis C virus genotype 1 or 4 infection who received elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks or elbasvir/grazoprevir plus ribavirin for 16 weeks were included in this analysis...
February 19, 2019: Journal of Gastroenterology and Hepatology
Roger H Kobayashi, Sudhir Gupta, Isaac Melamed, J Fernando Mandujano, Ai Lan Kobayashi, Bruce Ritchie, Bob Geng, Thomas Prescott Atkinson, Syed Rehman, Eva Turpel-Kantor, Jiří Litzman
Introduction: Subcutaneously administered immunoglobulin (SCIG) is increasingly used to treat patients with primary immunodeficiencies (PIDs). Octanorm (marketed as cutaquig® in USA and Canada) is a new 16.5% solution of human SCIG, manufactured by a process based on that of the intravenous preparation (IVIG) octagam®. Objectives: To investigate the efficacy, safety and tolerability of octanorm in a prospective, open-label, single-arm phase 3 study involving adult and pediatric patients with PIDs (NCT01888484; clinicaltrials...
2019: Frontiers in Immunology
Lisa A Prosser, Rafael Harpaz, Angela M Rose, Acham Gebremariam, Angela Guo, Ismael R Ortega-Sanchez, Fangjun Zhou, Kathleen Dooling
Background: The U.S. Advisory Committee on Immunization Practices recently developed recommendations for use of a new recombinant zoster vaccine (RZV). Objective: To evaluate the cost-effectiveness of vaccination with RZV compared with zoster vaccine live (ZVL) and no vaccination, the cost-effectiveness of vaccination with RZV for persons who have previously received ZVL, and the cost-effectiveness of preferential vaccination with RZV over ZVL. Design: Simulation (state-transition) model using U...
February 19, 2019: Annals of Internal Medicine
Katherine C Konvinse, Jason A Trubiano, Rebecca Pavlos, Ian James, Christian M Shaffer, Cosmin A Bejan, Ryan J Schutte, David A Ostrov, Mark A Pilkinton, Misha Rosenbach, Jeffrey P Zwerner, Kristina B Williams, Jack Bourke, Patricia Martinez, Francois Rwandamuriye, Abha Chopra, Mark Watson, Alec J Redwood, Katie D White, Simon A Mallal, Elizabeth J Phillips
BACKGROUND: Vancomycin is a prevalent cause of the severe hypersensitivity syndrome drug reaction with eosinophilia and systemic symptoms (DRESS) which leads to significant morbidity and mortality and commonly occurs in the setting of combination antibiotic therapy which impacts future treatment choices. Variations in human leukocyte antigen (HLA) class I in particular have been associated with serious T-cell mediated adverse drug reactions which has led to preventive screening strategies for some drugs...
February 15, 2019: Journal of Allergy and Clinical Immunology
R G Hanna-Sawires, J V Groen, F A Klok, R A E M Tollenaar, W E Mesker, R J Swijnenburg, A L Vahrmeijer, B A Bonsing, J S D Mieog
BACKGROUND: Postpancreatectomy haemorrhage (PPH) and venous thromboembolism (VTE) are serious complications following pancreatic surgery. The aim was to assess the timing, occurrence and predictors of PPH and VTE. METHODS: Elective pancreatic resections undertaken in a single university hospital between November 2013 and September 2017 were assessed. Three intervals were reviewed, each with a different routine regimen of nadroparin: 2850 units once daily (single dose) administered in hospital only, or 5700 units once daily (double dose) or 2850 units twice daily (split dose) administered in hospital and continued for 6 weeks after surgery...
February 18, 2019: British Journal of Surgery
Liming Lu, Jingchun Zeng, Zehuai Wen, Chunzhi Tang, Nenggui Xu
BACKGROUND: Hepatocellular carcinoma, also called malignant hepatoma, is a primary malignancy of the liver. Despite regular surveillance conducted in high-risk populations, most people with hepatocellular carcinoma are diagnosed at an advanced stage. Consequently, only a minority of people with the disease are suitable for surgical resection when diagnosed. OBJECTIVES: To compare the beneficial and harmful effects of transcatheter arterial chemoembolisation (TACE) followed by three-dimensional conformal radiotherapy (3-DCRT) versus TACE alone in adults with primary hepatocellular carcinoma, considered unsuitable for surgical resection...
February 16, 2019: Cochrane Database of Systematic Reviews
Godfrey Ja Walker, Damian Walker, Daniel Molano Franco, Carlos F Grillo-Ardila
BACKGROUND: Congenital syphilis continues to be a substantial public health problem in many parts of the world. Since the first use of penicillin for the treatment of syphilis in 1943, which was a notable early success, it has remained the preferred and standard treatment including for congenital syphilis. However, the treatment of congenital syphilis is largely based on clinical experience and there is extremely limited evidence on the optimal dose or duration of administration of penicillin or the use of other antibiotics...
February 15, 2019: Cochrane Database of Systematic Reviews
David E Bernstein, Albert Tran, Paul Martin, Kris V Kowdley, Marc Bourliere, Mark S Sulkowski, Paul J Pockros, Boris Renjifo, Deli Wang, Diana L Shuster, Daniel E Cohen, Ira M Jacobson
Introduction: Patients with hepatitis C virus (HCV) infection and chronic kidney disease (CKD) are a high-priority population for treatment. Methods: We performed a post hoc pooled efficacy and safety analysis that included HCV genotype 1-infected patients with compensated liver disease and CKD stages 1 to 3 who received the all-oral 3-direct-acting antiviral regimen of ombitasvir, paritaprevir, ritonavir, and dasabuvir ± ribavirin (OBV/PTV/r + DSV ± RBV) in 11 phase 3 clinical trials...
February 2019: KI Reports
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