Results 1 to 10 of about 600,809 (212)

Postmarketing surveillance of adverse events following meningococcal B vaccination: data from Apulia Region, 2014–19 [PDF]

Hum Vaccin Immunother, 2021
Since the multicomponent meningococcal B vaccine introduction, the Apulian Regional Health Authority implemented postmarketing surveillance program, as provided by Italian laws.
Pasquale Stefanizzi, Francesco Paolo Bianchi, Giuseppe Spinelli, Fabio Amoruso, Domenica Ancona, Paolo Stella, Silvio Tafuri   +6 more
semanticscholar   +3 more sources

Safety of Brexanolone in Adults with Postpartum Depression: Postmarketing Surveillance Data [PDF]

Drugs Real World Outcomes, 2023
Background Brexanolone is currently the only medication approved by the US FDA for the treatment of postpartum depression (PPD) in patients ≥15 years. Brexanolone is available commercially only through a restricted program (ZULRESSO^® Risk Evaluation and
Svetlana Garafola, Elizabeth W Shiferaw, Vikram Dev   +2 more
semanticscholar   +2 more sources

Severe Gastrointestinal Toxicity Following the Use of Gilteritinib: A Case Series and Analysis of Postmarketing Surveillance Data [PDF]

Healthcare (Basel), 2023
Gilteritinib has been approved as monotherapy in adults with acute myeloid leukemia (AML) FLT3 mutated with relapsed or refractory disease, in light of its advantages in terms of survival and the favorable safety profile.
L. Gozzo, A. Nardo, Serena B. Brancati, Antongiulio Judica, A. Duminuco, C. Maugeri, M. Parisi, L. Longo, D. Vitale, Rosy Ruscica, G. L. Romano, E. Mauro, P. Fiumara, G. Palumbo, F. Di Raimondo, C. Vetro, F. Drago   +16 more
semanticscholar   +2 more sources

Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices.

JAMA Intern Med, 2023
Importance The US Food and Drug Administration (FDA) is building a national postmarketing surveillance system for medical devices, moving to a "total product life cycle" approach whereby more limited premarketing data are balanced with postmarketing ...
Xuan Wang, Vidul Ayakulangara Panickan, T. Cai, Xin Xiong, Kelly Cho, Tianxi Cai, Florence T. Bourgeois   +6 more
semanticscholar   +2 more sources

Real‐world safety of nivolumab in patients with non‐small‐cell lung cancer in Japan: Postmarketing surveillance [PDF]

Cancer Sci, 2021
Postmarketing surveillance of Japanese patients with unresectable, previously treated, advanced or recurrent non‐small‐cell lung cancer treated with nivolumab was undertaken during the conditional approval period.
N. Yamamoto, Y. Nakanishi, A. Gemma, K. Nakagawa, Takahiko Sakamoto, Ayumi Akamatsu, Y. Ohe   +6 more
semanticscholar   +2 more sources

Safety of Gliadel Implant for Malignant Glioma: Report of Postmarketing Surveillance in Japan [PDF]

Neurol Med Chir (Tokyo), 2021
Clinical trial data of Carmustine implant (Gliadel Wafer) in Japanese patients with malignant glioma are limited; thus, we conducted a postmarketing surveillance study to evaluate the safety of Gliadel in real-world clinical practice in Japan.
R. Nishikawa, H. Iwata, Y. Sakata, K. Muramoto, T. Matsuoka   +4 more
semanticscholar   +2 more sources

Long-term effectiveness of Gliadel implant for malignant glioma and prognostic factors for survival: 3-year results of a postmarketing surveillance in Japan [PDF]

Neurooncol Adv, 2022
Background Adjuvant treatment with Gliadel wafers may prolong overall survival (OS) for malignant glioma patients without increasing toxicity. In Japan, the long-term OS of these patients treated with Gliadel 7.7 mg implants has not been studied.
T. Iuchi, Akihiro Inoue, Y. Hirose, M. Morioka, Keishi Horiguchi, A. Natsume, Y. Arakawa, K. Iwasaki, M. Fujiki, T. Kumabe, Y. Sakata   +10 more
semanticscholar   +2 more sources

Myelodysplastic Syndrome/Acute Myeloid Leukemia Following the Use of Poly-ADP Ribose Polymerase (PARP) Inhibitors: A Real-World Analysis of Postmarketing Surveillance Data [PDF]

Front Pharmacol, 2022
Background and purpose: poly-ADP ribose polymerase (PARP) inhibitors show impressive efficacy in a range of tumors. However, concerns about rare and fatal adverse events, including myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML) have ...
Quanfeng Zhao, Pan Ma, Peishu Fu, Jiayu Wang, Kejing Wang, Lin Chen, Yang Yang   +6 more
semanticscholar   +2 more sources

Large-Scale Postmarketing Surveillance of Biological Drugs for Immune-Mediated Inflammatory Diseases Through an Italian Distributed Multi-Database Healthcare Network: The VALORE Project [PDF]

BioDrugs, 2021
Biological drugs have improved the management of immune-mediated inflammatory diseases (IMIDs) despite being associated with important safety issues such as immunogenicity, infections, and malignancies in real-world settings. The aim of this study was to
G. Trifirò, Valentina Isgró, Y. Ingrasciotta, Valentina Ientile, Luca L’Abbate, S. S. Foti, V. Belleudi, F. Poggi, Andrea Fontana, Ugo Moretti, Riccardo Lora, Alberto Sabaini, Ilenia Senesi, Carla Sorrentino, M. R. Puzo, Angela Padula, Mariano Fusco, R. Giordana, V. Solfrini, Aurora Puccini, Paola Rossi, Stefania Del Zotto, Olivia Leoni, M. Zanforlini, D. Ancona, V. Bavaro, D. Garau, S. Ledda, Salvatore Scondotto, A. Allotta, Marco Tuccori, R. Gini, Giampaolo Bucaneve, D. Franchini, Anna Cavazzana, Valeria Biasi, Stefania Spila Alegiani, Marco Massari, Gianluca Ugo Riccardo Alberto Valentina Ylenia Valentina Lu Trifirò Moretti Lora Sabaini Isgrò Ingrasciotta Ie, G. Trifirò, Ugo Moretti, Riccardo Lora, Alberto Sabaini, Valentina Isgró, Y. Ingrasciotta, Valentina Ientile, Luca L’Abbate, S. S. Foti, Stefania Spila Alegiani, V. Belleudi, F. Poggi, Andrea Fontana, Marco Massari, Ilaria Andretta, Matilde Tanaglia, Ilenia Senesi, Carla Sorrentino, M. R. Puzo, Angela Padula, A. Carriero, Sergio Sassano, G. De Sarro, Simona Mirarchi, Caterina Palleria, C. Sarro, Mariano Fusco, R. Giordana, M. Balestrieri, S. Rostan, A. Capuano, F. Bernardi, U. Trama, A. Russo, M. G. Fumo, A. Addis, F. Musicco, V. Solfrini, Ester Sapigni, Aurora Puccini, I. Mazzetti, Debora Podetti, Anna Maria Potenza, V. Nikitina, Rita Ricciardelli, Nazanin Mogheiseh, S. Croce, Paola Rossi, Aba Pettinelli, Stefania Del Zotto, Lucian Ejlli, Olivia Leoni, I. Fortino, Michele Ercolanoni, A. Mazzone, A. Nisic, S. Schiatti, M. Ludergnani, M. Zanforlini, M. Mancini, Luigi Patregnani, P. Fabbietti, E. Antonicelli, A. Mangano, A. Campomori, S. A. Urru, Giorgio Costa, G. Guarrera, D. Ancona, V. Bavaro, P. Stella, D. Garau, E. Serra, S. Ledda, P. Carta, Salvatore Scondotto, A. Allotta, R. Gini, Marco Tuccori, A. Vannacci, E. Lucenteforte, M. Parrilli, I. Convertino, Giampaolo Bucaneve, M. De Giorgi, D. Franchini, Rosalba Elisabetta Rocchi, Mariangela Rossi, G. Scroccaro, Anna Cavazzana, Valeria Biasi, P. Deambrosis, Giampietro Grindelli, E. Ferroni   +132 more
semanticscholar   +2 more sources

Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease [PDF]

Stem Cells Transl Med, 2021
Buerger's disease or thromboangiitis obliterans is a type of obstructive vascular diseases categorized as vasculitis and usually present in 95% of young smoker men.
P. Gupta, S. Dutta, S. Kala, Muralikrishna Nekkanti, S. Desai, S. Mahapatra, A. Dhar, Radhakrishnan Raju, Rajkumar M, A. Behera, S. P, N. S. Raviraja, Pachaiyappan Viswanathan, M. Chandrashekar, Charan Thej, Prasanth K V, Jijy Abraham, Hema Boggarapu, K. Udaykumar   +18 more
semanticscholar   +2 more sources