A Japanese Post-Marketing Surveillance of Regorafenib in Colorectal Cancer Patients: Interim Report
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چکیده
منابع مشابه
Panitumumab in Japanese Patients with Unresectable Colorectal Cancer: A Post-marketing Surveillance Study of 3085 Patients†
OBJECTIVE Panitumumab was approved in Japan in April 2010 for the treatment of Kirsten rat sarcoma-2 virus oncogene wild-type unresectable and recurrent colorectal cancer. We conducted a post-marketing surveillance study to evaluate the safety and effectiveness of panitumumab. METHODS After panitumumab was commercially available in Japan, all patients to be treated with panitumumab were enrol...
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OBJECTIVE Cetuximab (Erbitux(®)) was approved for the treatment of metastatic colorectal cancer in Japan in 2008. To verify information on the safety in practical use of cetuximab, we conducted post-marketing surveillance in accordance with the conditions for approval. METHODS All patients to be treated with cetuximab were enrolled by the central enrolment method. Data on treatment status, an...
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INTRODUCTION Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillan...
متن کاملJapanese Physicians’ Views on Drug Post-Marketing Surveillance
BACKGROUND Registration trials leading to the approval of drugs are paramount in drug development. After approval, continuous efforts are necessary to ensure proper use of the approved drugs. In Japan, post-marketing surveillance (PMS) by drug companies is conducted in accordance with good post-marketing study practice (GPSP). Although the global standard for pharmacovigilance is incorporated i...
متن کاملPost-treatment surveillance in colorectal cancer
BACKGROUND Though the post treatment surveillance of patients with colorectal cancer (CRC) treated with curative intent is common practice, its value is controversial. In the absence of conclusive clinical data, various modalities for the routine follow-up of patients with CRC have been proposed. In practice, the guidelines across countries and regions differ and are influenced by different hea...
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ژورنال
عنوان ژورنال: Annals of Oncology
سال: 2014
ISSN: 0923-7534
DOI: 10.1093/annonc/mdu421.2