Remarkable improvements in outcomes for many haematological malignancies have been driven primarily by a proliferation of novel therapeutics over the past two decades. Targeted agents, immune and cellular therapies, and combination regimens have adverse event profiles distinct from conventional finite cytotoxic chemotherapies. In 2018, a Commission comprising patient advocates, clinicians, clinical investigators, regulators, biostatisticians, and pharmacists representing a broad range of academic and clinical cancer expertise examined issues of adverse event evaluation in the context of both newer and existing therapies for haematological cancers. The Commission proposed immediate actions and long-term solutions in the current processes in adverse event assessment, patient-reported outcomes in haematological malignancies, toxicities in cellular therapies, long-term toxicity and survivorship in haematological malignancies, issues in regulatory approval from an international perspective, and toxicity reporting in haematological malignancies and the real-world setting. In this follow-up report, the Commission describes progress that has been made in these areas since the initial report.

中文翻译：

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超越最高等级：血液恶性肿瘤不良事件评估和报告现代化的进展和未来方向。

在过去的二十年里，许多血液恶性肿瘤的结果显着改善主要是由于新疗法的激增。靶向药物、免疫和细胞疗法以及联合疗法具有不同于传统有限细胞毒性化学疗法的不良事件特征。2018 年，一个由患者倡导者、临床医生、临床研究人员、监管机构、生物统计学家和药剂师组成的委员会代表了广泛的学术和临床癌症专业知识，在血液癌症的新疗法和现有疗法的背景下检查了不良事件评估问题。委员会在不良事件评估、血液恶性肿瘤患者报告的结果、细胞疗法的毒性、血液系统恶性肿瘤的长期毒性和存活率、从国际角度来看的监管批准问题，以及血液系统恶性肿瘤和现实环境中的毒性报告。在这份后续报告中，委员会描述了自初次报告以来在这些领域取得的进展。