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A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer. %PDF-1.6 %���� Adverse events that occurred more than 12 weeks after the final injection of the study drug were reported only if they were determined to be related to the study drug by the investigator. 30. Lancet Oncol 2002;3:453-453, 20. J Clin Oncol 2009;27:1564-1571, 8. Yields reach 9.6% for prime UK business parks. Castration-resistant disease was defined as a serum testosterone level of 50 ng per deciliter or lower (≤1.7 nmol per liter) after bilateral orchiectomy or during maintenance treatment consisting of androgen-ablation therapy with a luteinizing hormone–releasing hormone agonist or polyestradiol phosphate. endstream endobj startxref N Engl J Med 2012;367:1187-1197. h�bbd```b``�"�ًA$���"Y-A$�0�X��n ����g �e�LP�� $#܁��S1L@��A�@�aE�g`Һ` ��� Subscribe today and stay informed. Silberstein EB. High-linear energy transfer irradiation targeted to skeletal metastases by the alpha-emitter 223Ra: adjuvant or alternative to conventional modalities? 31. Do you also want to receive new product announcements and technology updates from Parker Tube Fittings Division? In the updated analysis, the median overall survival was 14.9 months in the radium-223 group and 11.3 months in the placebo group (Figure 1A). Henriksen G, Fisher DR, Roeske JC, Bruland OS, Larsen RH. Eur J Cancer 2012;48:678-686, 25. An independent data and safety monitoring committee was responsible for evaluating the results of the interim analysis. Register to unlock access to the Best of the Internet. As prespecified in the protocol, the Lan–DeMets alpha spending approach27 was applied with O'Brien–Fleming stopping boundaries28 to evaluate the difference in overall survival between the two groups. Case Records of the Massachusetts General Hospital, Racial Disproportionality in Covid Clinical Trials, Transgender Women on College Athletic Teams — The Case of Lindsay Hecox, Early Spread of SARS-CoV-2 in the Icelandic Population, Preterm Birth and 17OHP — Why the FDA Should Not Withdraw Approval, Withdrawing Approval of Makena — A Proposal from the FDA Center for Drug Evaluation and Research, SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19, Remdesivir for the Treatment of Covid-19 — Final Report, Colchicine in Patients with Chronic Coronary Disease, http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf. Comments. Sartor O. Additional eligibility criteria included a baseline PSA level of 5 ng per milliliter or higher with evidence of progressively increasing PSA values (two consecutive increases over the previous reference value); an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 2 (on a scale of 0 to 5, with 0 indicating no symptoms and full activity and higher scores indicating greater functional compromise25) (see the definitions of ECOG performance-status scores in the Supplementary Appendix, available at NEJM.org); a life expectancy of 6 months or longer; and adequate hematologic, renal, and liver function.

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