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Advancing Drug Safety Through Prospective Pharmacovigilance.
Pitts PJ, Le Louet H. Pitts PJ, et al. Ther Innov Regul Sci. 2018 Jul;52(4):400-402. doi: 10.1177/2168479018766887. Epub 2018 Apr 1. Ther Innov Regul Sci. 2018. PMID: 29714580
To improve the ability of patients to receive high-quality, safe, effective, and timely care, better information via pharmacovigilance must be a priority as the world's many regulatory systems build the capacity to harness electronic health information to improve health, c …
To improve the ability of patients to receive high-quality, safe, effective, and timely care, better information via pharmacovigilance
Advancing drug safety science by integrating molecular knowledge with post-marketing adverse event reports.
Soldatos TG, Kim S, Schmidt S, Lesko LJ, Jackson DB. Soldatos TG, et al. CPT Pharmacometrics Syst Pharmacol. 2022 May;11(5):540-555. doi: 10.1002/psp4.12765. Epub 2022 Feb 20. CPT Pharmacometrics Syst Pharmacol. 2022. PMID: 35143713 Free PMC article. Review.
Several methods have been developed to analyze such data, aiming to improve pharmacovigilance and drug safety. In this work, we provide a brief review of key directions to quantitatively analyzing adverse events and explore the potential of augmenting these m …
Several methods have been developed to analyze such data, aiming to improve pharmacovigilance and drug safety. In this …
Safety, recommended dose, efficacy and immune correlates for nintedanib in combination with pembrolizumab in patients with advanced cancers.
Baldini C, Danlos FX, Varga A, Texier M, Halse H, Mouraud S, Cassard L, Champiat S, Signolle N, Vuagnat P, Martin-Romano P, Michot JM, Bahleda R, Gazzah A, Boselli L, Bredel D, Grivel J, Mohamed-Djalim C, Escriou G, Grynszpan L, Bigorgne A, Rafie S, Abbassi A, Ribrag V, Postel-Vinay S, Hollebecque A, Susini S, Farhane S, Lacroix L, Parpaleix A, Laghouati S, Zitvogel L, Adam J, Chaput N, Soria JC, Massard C, Marabelle A. Baldini C, et al. J Exp Clin Cancer Res. 2022 Jul 7;41(1):217. doi: 10.1186/s13046-022-02423-0. J Exp Clin Cancer Res. 2022. PMID: 35794623 Free PMC article. Clinical Trial.
BACKGROUND: We aimed to determine the safety and efficacy of nintedanib, an oral anti-angiogenic tyrosine kinase inhibitor, in combination with pembrolizumab, an anti-PD1 immunotherapy, in patients with advanced solid tumors (PEMBIB trial; NCT02856425). ...TRIAL REG …
BACKGROUND: We aimed to determine the safety and efficacy of nintedanib, an oral anti-angiogenic tyrosine kinase inhibitor, in combin …
Supervised Machine Learning-Based Decision Support for Signal Validation Classification.
Imran M, Bhatti A, King DM, Lerch M, Dietrich J, Doron G, Manlik K. Imran M, et al. Drug Saf. 2022 May;45(5):583-596. doi: 10.1007/s40264-022-01159-2. Epub 2022 May 17. Drug Saf. 2022. PMID: 35579820 Free PMC article.
METHODS: We extracted cumulative data for six medicinal products, consisting of historic SDR validations and Individual Case Safety Reports, from the company's safety database for training and testing of the ML model. ...The applicability of the model was confirmed …
METHODS: We extracted cumulative data for six medicinal products, consisting of historic SDR validations and Individual Case Safety R …
Clinical perspectives in drug safety and adverse drug reactions.
Pillans PI. Pillans PI. Expert Rev Clin Pharmacol. 2008 Sep;1(5):695-705. doi: 10.1586/17512433.1.5.695. Expert Rev Clin Pharmacol. 2008. PMID: 24422739
Regulatory authorities have tended to act later rather than sooner in response to safety signals, and this, when combined with under-reporting, may have led to exposure of a large number of patients to drug-related harm before restriction or withdrawal. ...Drug
Regulatory authorities have tended to act later rather than sooner in response to safety signals, and this, when combined with under- …
Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.
Banerjee AK, Okun S, Edwards IR, Wicks P, Smith MY, Mayall SJ, Flamion B, Cleeland C, Basch E; Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium. Banerjee AK, et al. Drug Saf. 2013 Dec;36(12):1129-49. doi: 10.1007/s40264-013-0113-z. Drug Saf. 2013. PMID: 24092596 Free PMC article.
The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. ...The members of the PROSPER Consortium therefore direct this PRO-AE guidance to multiple stak …
The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better i …
Real-world safety and effectiveness of radium-223 in Japanese patients with castration-resistant prostate cancer (CRPC) and bone metastasis: exploratory analysis, based on the results of post-marketing surveillance, according to prior chemotherapy status and in patients without concomitant use of second-generation androgen-receptor axis-targeted agents.
Uemura H, Masumori N, Takahashi S, Hosono M, Kinuya S, Sunaya T, Horio T, Okayama Y, Kakehi Y. Uemura H, et al. Int J Clin Oncol. 2021 Apr;26(4):753-763. doi: 10.1007/s10147-020-01850-3. Epub 2021 Feb 11. Int J Clin Oncol. 2021. PMID: 33575828 Free PMC article.
Incidences of TEAEs (61%), drug-related TEAEs (36%), and grade 3 drug-related hematological events (12%) were numerically higher in 33 patients who had received two lines of prior chemotherapy. ...CONCLUSION: In a real-life setting, radium-223 was well tolerated irr …
Incidences of TEAEs (61%), drug-related TEAEs (36%), and grade 3 drug-related hematological events (12%) were numerically high …
Safety and efficacy of Tolvaptan in real-world patients with autosomal dominant polycystic kidney disease- interim results of SLOW-PKD surveillance.
Mochizuki T, Muto S, Miyake M, Tanaka T, Wang W. Mochizuki T, et al. Clin Exp Nephrol. 2021 Nov;25(11):1231-1239. doi: 10.1007/s10157-021-02100-0. Epub 2021 Jul 6. Clin Exp Nephrol. 2021. PMID: 34228250 Free PMC article.
BACKGROUND: Tolvaptan is a vasopressin type 2 receptor antagonist and has been used to treat autosomal dominant polycystic kidney disease (ADPKD) since 2014. There has been limited real-world data on the safety and efficacy of tolvaptan. METHODS: This post-marketing survei …
BACKGROUND: Tolvaptan is a vasopressin type 2 receptor antagonist and has been used to treat autosomal dominant polycystic kidney disease (A …
Nivolumab in routine practice for older patients with advanced or metastatic non-small cell lung cancer.
Sabatier R, Nicolas E, Paciencia M, Jonville-Béra AP, Madroszyk A, Cecile M, Braticevic C, Duran S, Tassy L, Rouby F, Micallef J, Rousseau F. Sabatier R, et al. J Geriatr Oncol. 2018 Sep;9(5):494-500. doi: 10.1016/j.jgo.2018.02.011. Epub 2018 Mar 9. J Geriatr Oncol. 2018. PMID: 29530494
Despite the fact that most of these cancers are being diagnosed in the older patients, few of the patients were included in pivotal trials. We aimed to describe efficacy and safety in a "real-world" older population. PATIENTS AND METHODS: We retrospectively collected data …
Despite the fact that most of these cancers are being diagnosed in the older patients, few of the patients were included in pivotal trials. …
Safety profile of repeated rituximab cycles in unselected rheumatoid arthritis patients: a long-term, prospective real-life study.
Vassilopoulos D, Delicha EM, Settas L, Andrianakos A, Aslanidis S, Boura P, Katsounaros M, Athanassiou P, Tempos K, Skarantavos G, Antoniadis C, Papazoglou S, Sakkas L, Galanopoulou V, Skopouli F, Boki K, Daoussis D, Vritzali E, Sfikakis PP. Vassilopoulos D, et al. Clin Exp Rheumatol. 2016 Sep-Oct;34(5):893-900. Epub 2016 Jul 5. Clin Exp Rheumatol. 2016. PMID: 27383049 Free article.
METHODS: This was a multicentre (17 Greek Rheumatology sites), prospective, long-term, pharmacovigilance study of patients with moderate to severe RA and an inadequate response or intolerance to 1 anti-tumour necrosis factor (TNF) agents. ...CONCLUSIONS: Long-term R …
METHODS: This was a multicentre (17 Greek Rheumatology sites), prospective, long-term, pharmacovigilance study of patients wit …
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