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Wyświetlanie 1-20 z 38
Tytuł:
Participant-centred active surveillance of adverse events following immunisation: a narrative review.
Autorzy:
Cashman P; Hunter New England Population Health, Newcastle, Australia.; University of Newcastle, NSW, Australia.
Macartney K; National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Sydney, Australia.; Discipline of Child and Adolescent Health, Sydney Medical School, University of Sydney, Australia.
Khandaker G; Discipline of Child and Adolescent Health, Sydney Medical School, University of Sydney, Australia.; Marie Bashir Institute for Infectious Diseases and Biosecurity (MBI), University of Sydney, Australia.; Asian Institute of Disability and Development (AIDD), University of South Asia, Dhaka, Bangladesh.
King C; National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Sydney, Australia.
Gold M; University of Adelaide, Discipline pf Paediatrics, Women's and Children's Health Network, Adelaide, Australia.
Durrheim DN; Hunter New England Population Health, Newcastle, Australia.; Hunter Medical Research Institute, 1 Kookaburra Circuit, New Lambton Heights, NSW, Australia.
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Źródło:
International health [Int Health] 2017 May 01; Vol. 9 (3), pp. 164-176.
Typ publikacji:
Journal Article; Review
MeSH Terms:
Adverse Drug Reaction Reporting Systems*
Product Surveillance, Postmarketing*
Vaccines/*adverse effects
Humans
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
Use of Live Attenuated Influenza Vaccine in Children With Egg Allergy and Asthma.
Autorzy:
Kelso JM; Division of Allergy, Asthma and Immunology, Scripps Clinic, San Diego, California.
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Źródło:
Journal of the Pediatric Infectious Diseases Society [J Pediatric Infect Dis Soc] 2015 Mar; Vol. 4 (1), pp. 81-2. Date of Electronic Publication: 2014 Dec 26.
Typ publikacji:
Letter; Comment
MeSH Terms:
Product Surveillance, Postmarketing*
Adverse Drug Reaction Reporting Systems/*statistics & numerical data
Drug-Related Side Effects and Adverse Reactions/*epidemiology
Influenza Vaccines/*adverse effects
Female ; Humans ; Male
Opinia redakcyjna
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
The Safety Profile of Vedolizumab in Ulcerative Colitis and Crohn's Disease: 4 Years of Global Post-marketing Data.
Autorzy:
Cohen RD; Department of Medicine, Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL, USA.
Bhayat F; Takeda Pharmaceuticals International Co., Global Patient Safety, Cambridge, MA, USA.
Blake A; Takeda Pharmaceuticals International Co., Global Patient Safety, Cambridge, MA, USA.
Travis S; Translational Gastroenterology Unit, National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK.
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Źródło:
Journal of Crohn's & colitis [J Crohns Colitis] 2020 Feb 10; Vol. 14 (2), pp. 192-204.
Typ publikacji:
Journal Article
MeSH Terms:
Antibodies, Monoclonal, Humanized/*adverse effects
Colitis, Ulcerative/*drug therapy
Crohn Disease/*drug therapy
Gastrointestinal Agents/*adverse effects
Aged ; Antibodies, Monoclonal, Humanized/therapeutic use ; Digestive System Diseases/chemically induced ; Female ; Gastrointestinal Agents/therapeutic use ; Gastrointestinal Diseases/chemically induced ; Humans ; Infusions, Intravenous/adverse effects ; Lupus Erythematosus, Systemic/chemically induced ; Male ; Neoplasms/chemically induced ; Product Surveillance, Postmarketing
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
Five-year Safety Data From OPUS, a European Observational Safety Registry for Adults With Ulcerative Colitis Treated With Originator Infliximab [Remicade®] or Conventional Therapy.
Autorzy:
Panés J; Department of Gastroenterology, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
Lindsay JO; Department of Gastrointestinal and Liver Services, Royal London Hospital, Barts Health NHS Trust, London, UK.
Teich N; Innere Medizin/Gastroenterologie, Internistische Gemeinschaftspraxis, Leipzig, Germany.
Lindgren S; Department of Gastroenterology, Lund University, Malmo, Sweden.
Colombel JF; Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Cornillie F; Global Medical Affairs, MSD International, Kriens-Luzern, Switzerland.
Flynn HA; MRL, Merck & Co., Inc., Kenilworth, NJ, USA.
Huyck S; MRL, Merck & Co., Inc., Kenilworth, NJ, USA.
Stryszak P; MRL, Merck & Co., Inc., Kenilworth, NJ, USA.
Yao R; MRL, Merck & Co., Inc., Kenilworth, NJ, USA.
Philip G; MRL, Merck & Co., Inc., Kenilworth, NJ, USA.
Reinisch W; Klinische Abt. Gastroenterologie & Hepatologie, Universitätsklinik für Innere Medizin III, Vienna, Austria.
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Źródło:
Journal of Crohn's & colitis [J Crohns Colitis] 2019 Sep 19; Vol. 13 (9), pp. 1148-1157.
Typ publikacji:
Comparative Study; Journal Article; Observational Study
MeSH Terms:
Colitis, Ulcerative/*drug therapy
Gastrointestinal Agents/*therapeutic use
Infliximab/*therapeutic use
Adrenal Cortex Hormones/therapeutic use ; Adult ; Europe ; Female ; Gastrointestinal Agents/adverse effects ; Humans ; Immunosuppressive Agents/therapeutic use ; Infections/chemically induced ; Infliximab/adverse effects ; Male ; Product Surveillance, Postmarketing ; Prospective Studies ; Registries
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Optimizing drug development in oncology by clinical trial simulation: Why and how?
Autorzy:
Gal J; Epidemiology and Biostatistics Unit at the Antoine Lacassagne Center, Nice, France.
Milano G; Antoine Lacassagne Center, Nice, France.
Ferrero JM; Antoine Lacassagne Center, Nice, France.
Saâda-Bouzid E; University of Nice, France.
Viotti J; University of Nice, France.
Chabaud S; Centre Le´on Be´ rard, Lyons, France.
Gougis P; Pitie´-Salp^etrie`re Hospital in Paris, France.
Le Tourneau C; Institute Curie of Paris, France.
Schiappa R; Antoine Lacassagne Center, Nice, France.
Paquet A; Molecular and Cellular Pharmacology Institute of Sophia Antipolis, Valbonne, France.
Chamorey E; Antoine Lacassagne Center, Nice, France.
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Źródło:
Briefings in bioinformatics [Brief Bioinform] 2018 Nov 27; Vol. 19 (6), pp. 1203-1217.
Typ publikacji:
Journal Article; Review
MeSH Terms:
Clinical Trials as Topic*
Drug Development*
Medical Oncology*
Neoplasms/*therapy
Biomedical Research ; Computational Biology ; Computer Simulation ; Drug Approval/legislation & jurisprudence ; Europe ; Health Policy ; Humans ; Product Surveillance, Postmarketing ; United States
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Arm Paralysis After Routine Childhood Vaccinations: Application of Advanced Molecular Methods to the Causality Assessment of an Adverse Event After Immunization.
Autorzy:
Shaw J; Department of Pediatrics, Division of Infectious Diseases, State University of New York Upstate Medical University, Golisano Children's Hospital, Syracuse.
Halsey NA; Institute for Vaccine Safety, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Weinberg A; Departments of Pediatrics, Medicine and Pathology, Director, Molecular and Virology Clinical Laboratories, University of Colorado Denver, Aurora.
Scott Schmid D; National Center for Immunizations and Respiratory Diseases, Division of Viral Diseases, Atlanta, Georgia.
George KS; Laboratory of Viral Diseases, Wadsworth Center, New York State Department of Health, Clinical Professor, Department of Biomedical Sciences, University at Albany, SUNY.
Weldon WC; Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
Jordan M; Pediatrics, Divisions of Immunobiology, and Bone Marrow Transplantation and Immune Deficiency Cincinnati Children's Hospital/University of Cincinnati, Ohio.
Bryant PW; Laboratory of Viral Diseases, Wadsworth Center, New York State Department of Health, Albany.
LaRussa PS; Department of Pediatrics, Division of Pediatric Infectious Diseases, Columbia University, New York, New York.
Bradshaw DY; Department of Neurology, Upstate Medical University, New York, New York.
Harrington T; Centers for Disease Control and Prevention, National Center for Emerging, Zoonotic, and Infectious Diseases, Division of Healthcare Quality Promotion, Immunization Safety Office, Clinical Immunization Safety Assessment Project, Atlanta, Georgia.
Gershon A; Columbia University College of Physicians and Surgeons, New York, New York.
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Źródło:
Journal of the Pediatric Infectious Diseases Society [J Pediatric Infect Dis Soc] 2017 Sep 01; Vol. 6 (3), pp. e161-e164.
Typ publikacji:
Case Reports; Journal Article
MeSH Terms:
Arm*
Paralysis/*etiology
Vaccination/*adverse effects
Child ; Humans ; Infant ; Male ; Product Surveillance, Postmarketing
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
Intussusception Cases Among Children Admitted to Referral Hospitals in Kenya, 2002-2013: Implications for Monitoring Postlicensure Safety of Rotavirus Vaccines in Africa.
Autorzy:
Omore R; Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.; Department of Epidemiology, School of Health Sciences, University of Tampere, Finland.
Osawa F; Department of Surgery.
Musia J; Department of Pediatrics and Child Health, School of Medicine, University of Nairobi, Kenya.
Rha B; Division of Viral Diseases, US Centers for Disease Control and Prevention, Atlanta, Georgia.
Ismail A; Division of Disease Surveillance and Response, Ministry of Public Health and Sanitation, Nairobi, Kenya.
Kiulia NM; Enteric Viruses Research Group, Institute of Primate Research, Nairobi, Kenya.
Moke F; Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Vulule J; Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Wainaina AM; Kenyatta National Hospital, Nairobi, Kenya.
Tole J; Aga Khan University Hospital, Nairobi, Kenya.
Machoki SM; Aga Khan University Hospital, Nairobi, Kenya.
Nuorti JP; Department of Epidemiology, School of Health Sciences, University of Tampere, Finland.
Breiman RF; Global Health Institute, Emory University, Atlanta, Georgia.; Global Disease Detection Division, Kenya Office of the US Centers for Disease Control and Prevention, Nairobi, Kenya.
Parashar UD; Division of Viral Diseases, US Centers for Disease Control and Prevention, Atlanta, Georgia.
Montgomery JM; Global Disease Detection Division, Kenya Office of the US Centers for Disease Control and Prevention, Nairobi, Kenya.
Tate JE; Division of Viral Diseases, US Centers for Disease Control and Prevention, Atlanta, Georgia.
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Źródło:
Journal of the Pediatric Infectious Diseases Society [J Pediatric Infect Dis Soc] 2016 Dec; Vol. 5 (4), pp. 465-469. Date of Electronic Publication: 2015 Aug 25.
Typ publikacji:
Journal Article
MeSH Terms:
Patient Safety*
Intussusception/*epidemiology
Rotavirus Vaccines/*administration & dosage
Child, Preschool ; Female ; Humans ; Infant ; Infant, Newborn ; Intussusception/mortality ; Kenya/epidemiology ; Male ; Product Surveillance, Postmarketing ; Referral and Consultation ; Retrospective Studies ; Rotavirus Infections/epidemiology ; Rotavirus Infections/prevention & control
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
Safety of Adalimumab and Predictors of Adverse Events in 1693 Japanese Patients with Crohn's Disease.
Autorzy:
Ogata H; Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan .
Watanabe M; Department of Gastroenterology and Hepatology, Graduate School, Tokyo Medical and Dental University, Tokyo, Japan.
Matsui T; Department of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan.
Hase H; Medical Division at AbbVie G.K., Tokyo, Japan.
Okayasu M; Medical Division at AbbVie G.K., Tokyo, Japan.
Tsuchiya T; Medical Division at AbbVie G.K., Tokyo, Japan.
Shinmura Y; Medical Division at AbbVie G.K., Tokyo, Japan.
Hibi T; Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital Kitasato University, Tokyo, Japan.
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Źródło:
Journal of Crohn's & colitis [J Crohns Colitis] 2016 Sep; Vol. 10 (9), pp. 1033-41. Date of Electronic Publication: 2016 Mar 09.
Typ publikacji:
Journal Article; Multicenter Study; Observational Study
MeSH Terms:
Adalimumab/*adverse effects
Anti-Inflammatory Agents/*adverse effects
Crohn Disease/*drug therapy
Adalimumab/therapeutic use ; Adult ; Anti-Inflammatory Agents/therapeutic use ; Drug Administration Schedule ; Female ; Humans ; Induction Chemotherapy ; Injections, Subcutaneous ; Japan ; Logistic Models ; Male ; Middle Aged ; Product Surveillance, Postmarketing ; Prospective Studies ; Treatment Outcome
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
Safety and Efficacy of Granulocyte/Monocyte Apheresis in Steroid-Dependent Active Ulcerative Colitis with Insufficient Response or Intolerance to Immunosuppressants and/or Biologics [the ART Trial]: 12-week Interim Results.
Autorzy:
Dignass A; Department of Gastroenterology, Hepatology, Oncology and Metabolic Diseases, Markus-Krankenhaus, Frankfurt/Main, Germany .
Akbar A; IBD Unit, St Mark's Hospital and Academic Institute, London, UK.
Hart A; IBD Unit, St Mark's Hospital and Academic Institute, London, UK.
Subramanian S; Department of Gastroenterology, Royal Liverpool University Hospital, Liverpool, UK.
Bommelaer G; Service Hépatologie-Gastroentérologie, CHU Clermont-Ferrand, Clermont-Ferrand, France.
Baumgart DC; Department of Medicine, Division of Gastroenterology and Hepatology, Charité Medical Center - Virchow Hospital, Humboldt-University of Berlin, Germany.
Grimaud JC; Assistance PubliqueHôpitaux de Marseille, Marseille, France.
Cadiot G; Service d'Hépato-gastro-entérologie, CHU du Reims, Hôpital Robert Debré, Reims, France.
Makins R; Cheltenham General Hospital, Cheltenham, UK.
Hoque S; Barts Health NHS Trust, Whipps Cross University Hospital, London, UK.
Bouguen G; Service des Maladies de l'Appareil Digestif et CIC1414, University Hospital of Rennes, Pontchaillou, France.
Bonaz B; Clinique Universitaire d'Hépato-Gastroentérologie, CHU Grenoble, Grenoble, France.
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Źródło:
Journal of Crohn's & colitis [J Crohns Colitis] 2016 Jul; Vol. 10 (7), pp. 812-20. Date of Electronic Publication: 2016 Jan 27.
Typ publikacji:
Clinical Trial; Journal Article; Multicenter Study
MeSH Terms:
Colitis, Ulcerative/*therapy
Immunosuppressive Agents/*therapeutic use
Leukapheresis/*methods
Steroids/*therapeutic use
Adolescent ; Adult ; Aged ; Colitis, Ulcerative/drug therapy ; Female ; Follow-Up Studies ; Granulocytes ; Humans ; Male ; Middle Aged ; Monocytes ; Product Surveillance, Postmarketing ; Remission Induction ; Treatment Outcome ; Young Adult
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
Post-Licensure Surveillance of Trivalent Live-Attenuated Influenza Vaccine in Children Aged 2-18 Years, Vaccine Adverse Event Reporting System, United States, July 2005-June 2012.
Autorzy:
Haber P; Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;
Moro PL; Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;
Cano M; Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;
Vellozzi C; Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;
Lewis P; Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;
Woo EJ; Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland.
Broder K; Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;
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Źródło:
Journal of the Pediatric Infectious Diseases Society [J Pediatric Infect Dis Soc] 2015 Sep; Vol. 4 (3), pp. 205-13. Date of Electronic Publication: 2014 May 07.
Typ publikacji:
Journal Article
MeSH Terms:
Influenza Vaccines/*adverse effects
Influenza, Human/*prevention & control
Vaccines, Attenuated/*adverse effects
Vaccines, Inactivated/*adverse effects
Adolescent ; Bacterial Infections/epidemiology ; Bacterial Infections/etiology ; Child ; Child, Preschool ; Female ; Guillain-Barre Syndrome/chemically induced ; Guillain-Barre Syndrome/epidemiology ; Humans ; Hypersensitivity ; Influenza Vaccines/administration & dosage ; Influenza, Human/complications ; Influenza, Human/epidemiology ; Male ; Product Surveillance, Postmarketing ; Seizures/chemically induced ; Seizures/epidemiology ; Vaccines, Attenuated/administration & dosage ; Vaccines, Inactivated/administration & dosage
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Wyświetlanie 1-20 z 38

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