| Chinese: Statistical methods | |
Source text - Chinese
Statistical methods:
After the primary endpoint analysis CSR was completed, additional protocol deviations were reported. These affected the per-protocol populations used to perform the per-protocol analyses of the primary and key-secondary endpoints. As such, updated supportive analyses were conducted and reported in this CSR. The study was powered based on the primary and key secondary analyses. All efficacy analyses presented in this Final CSR are considered as supportive, and no formal statistical testing was performed.
Analysis of secondary or exploratory endpoints was descriptive and included summary statistics (e.g. as means, standard deviations, medians, 95% CIs, etc).
The following analysis populations were defined:
Full analysis set (FAS): comprises all enrolled patients who receive at least one dose of LCI699. FAS is used in efficacy analysis for study period other than randomized withdrawal period including key secondary endpoint.
Safety set (SAS): comprises all enrolled patients who received at least one dose of LCI699 and had at least one valid post-baseline safety assessment. Please note: the statement that a patient had no adverse events (on the Adverse Event CRF) constitutes a safety assessment.
| Translation - Chinese
统计学方法：
在CSR主要终点分析完成后，另外对方案偏离进行了报告。相关的方案偏离对符合方案人群产生了影响，该人群用于对主要终点和关键次要终点进行符合方案分析。因此，进行了最新的支持性分析，并在本CSR中报告。根据主要和关键次要终点分析，本研究具有统计学检验力。最终CSR中的所有疗效分析均考虑为支持性分析，且未进行正式的统计学检验。
次要终点或探索性终点分析均为描述性统计，其中包括汇总统计数据（如平均值、标准差、中位数、95%CI等）。
下列分析人群定义如下：
全分析集（FAS）：包括所有至少接受一剂次LCI699的入组患者。
FAS用于除随机撤药物期外的研究期的疗效分析（包括关键次要终点）。
安全性分析集（SAS）：包括所有至少接受一剂次LCI699且至少进行了一次有效的基线后安全性评估的入组患者。请注意：有关患者未出现不良事件的陈述（记录于不良事件CRF）构成了安全性评估。
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