In order to understand if there is other unknown side effect during the clinical trail, the PMS (Post-Marketing Study) will be conducted to learn more treatment experiences on patients, and collect their information for further study.
No. 9 of IRPMA COP Benchmarks regulates that all PMS shall go through JIRB, IRB or Ethics Committee and must be registered on the website of IRPMA PMS registry system. It is to ensure the studies conducted on patients have been approved by JIRB, IRB and protect patient’s right of privacy. The public can also get the information and objective of the PMS through the registry system.
Title of Study
A Phase 3b/4 Randomized Double Blind Study Of 5 mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis 2015-04-29
Bayer Taiwan Co., Ltd.
Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia 2015-04-29
An open-label, prospective interventional study of the tolerability and efficacy of oral Harnalidge® OCAS®(Tamsulosin) 0.4 mg in patients who are unsatisfied with the treatment of Tamsulosin 0.2 mg 2015-04-29
RACER (Ranibizumab AMD Clinical Efficacy in Real world practice): A multicenter, open-label, prospective, non-interventional study to evaluate the effectiveness and safety of Lucentis (ranibizumab) in naive wet Age-Related Macular Degeneration (wAMD) patients with vision impairment due to choroidal neovavscularization (CNV) over a 12-month observational period under real life conditions RACER (臨床評估年齡相關性黃斑部退化病變病患使用 ranibizumab 治療之有效性)：一項為期 12 個月，多中心、開放性、前瞻性、非介入性研究，觀察臨床使用樂舒晴(Lucentis®/ranibizumab)治療血管新生型(濕性)年齡相關性黃斑部退化病變 (wAMD)引起脈絡膜血管新生(CNV)而導致視覺障礙，且未曾接受過治療之病患，其有效性與安全性評估。 2015-04-29
An OPen-label, Randomized, Controlled, Multicenter Study ExplorIng TwO TreatmeNt StratEgiEs of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention 一項開放性、隨機分配、對照、多中心試驗，目的在於針對接受經皮冠狀動脈介入治療的心房纖維顫動受試者研究兩種Rivaroxaban治療策略以及一種劑量調整口服維生素K拮抗劑治療策略 2015-04-29
Bayer Taiwan (This is a global NIS study)
CORRELATE - Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings CORRELATE – 癌瑞格在例行臨床實踐環境的安全性與有效性 2015-04-29
Astellas Pharma Taiwan
An open-label, prospective interventional study of the tolerability and efficacy of oral Harnalidge® OCAS®(Tamsulosin) 0.4 mg in patients who are unsatisfied with the treatment of Tamsulosin 0.2 mg 一項開放式、前瞻性介入試驗，評估對Tamsulosin 0.2 mg 治療不滿意的患者，口服Harnalidge® OCAS® (Tamsulosin) 0.4 mg 之耐受性及療效 2015-04-29
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