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2. Neratinib causes significant gas
2. Neratinib causes significant gastrointestinal toxicity. Diarrhoea affects most patients, is severe in a high proportion, and can be expected to affect quality of life. Based on available data from study 6201, it is uncertain at this time whether the diarrhoea can be adequately managed by prophylactic anti-diarrhoeals. The very high rate of early discontinuations from this trial despite intensive loperamide prophylaxis is of concern. It is also unclear to what extent diarrhoea may improve over time for the individual patient who decides to remain on treatment after experiencing severe diarrhoea. In routine clinical practice, there may be an even greater rate of treatment discontinuations due to diarrhoea, leading to a reduction in efficacy. In the presence of a robustly demonstrated important clinical benefit the side effect profile might be considered acceptable, but is of major concern in the context of the deficiencies in the demonstration of efficacy.
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2.来那替尼引起显著胃肠道毒性。腹泻会影响大多数患者，严重的比例很高，并且可以预期会影响生活质量。基于从研究6201提供的数据，它是在这个时候是否腹泻可以通过预防性止泻充分管理不确定性。该试验的早期停药尽管密集洛哌丁胺预防率非常高是值得关注的。目前还不清楚到什么程度的腹泻可能会逐渐增加对个体患者谁决定在经历严重腹泻后，留在治疗。在常规的临床实践，有可能是停药治疗腹泻引起的更大的速度，导致药效降低。
正在翻译中..
2. Neratinib causes significant gastrointestinal toxicity. Diarrhoea affects most patients, is severe in a high proportion, and can be expected to affect quality of life. Based on available data from study 6201, it is uncertain at this time whether the diarrhoea can be adequately managed by prophylactic anti-diarrhoeals. The very high rate of early discontinuations from this trial despite intensive loperamide prophylaxis is of concern. It is also unclear to what extent diarrhoea may improve over time for the individual patient who decides to remain on treatment after experiencing severe diarrhoea. In routine clinical practice, there may be an even greater rate of treatment discontinuations due to diarrhoea, leading to a reduction in efficacy. In the presence of a robustly demonstrated important clinical benefit the side effect profile might be considered acceptable, but is of major concern in the context of the deficiencies in the demonstration of efficacy.
正在翻译中..
2。尼拉替尼引起严重的胃肠道毒性。腹泻影响大多数患者，严重程度很高，预计会影响生活质量。根据研究6201的现有数据，目前尚不确定预防性抗腹泻药是否能充分控制腹泻。尽管进行了大量的洛哌丁胺预防，但该试验的早期中止率非常高，值得关注。对于在经历严重腹泻后决定继续治疗的个体患者来说，腹泻随着时间的推移可能改善到何种程度，目前还不清楚。在常规的临床实践中，由于腹泻而中断治疗的比率可能更高，从而导致疗效下降。如果存在已被证实的重要临床益处，则副作用可能被认为是可接受的，但在证明疗效方面存在缺陷的情况下，则是主要关注的问题。<br>
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