The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. FDA已进行了一项新的分析研究现有的文献和上市后不良事件(AE)的报告。
Patient survival and severe adverse event rates were similar in both groups. 两组患者生存率和严重不良事件(AE)发生率相似。
The FDA is continuing to review adverse event reports and evaluate ways to reduce unintended exposures to these products. FDA将继续审查相关的不良事件(AE)报告,并对用于减少意外暴露于这些产品的方法进行评估。
No patient had a drug-related serious adverse event or discontinued because of toxicity. 没有患者出现药物相关的严重副作用或因为药物毒性中断治疗。
No data are available to support a correlation between RGV and adverse event rates. 目前尚无数据说明RGV与不良事件(AE)率之间的联系。