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可疑且非预期严重不良反应
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可疑且非预期严重不良反应
Encyclopedia
医学
可疑且非预期严重不良反应
释
suspected unexpected serious adverse reaction; SUSAR
可疑且非预期严重不良反应
在药物临床试验过程中发生的需住院治疗、延长住院时间、伤残、影响工作能力、危及生命或死亡、导致先天畸形等与试验药物至少可能有关的严重不良反应,且该严重不良反应的性质、严重程度或频度不同于先前方案或其他相关资料所描述的预期风险。
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