...................................................... 4
2. ............................................................................................................ 4
3. ............................................................................................................ 4
3.1 研究设计 ............................................................................................................................. 4
3.2 研究药物 ............................................................................................................................. 5
3.3 治疗计划 ............................................................................................................................. 5
3.4 剂量调整与停药 ................................................................................................................. 5
4. ............................................................................................................ 6
4.1 主要疗效指标 ..................................................................................................................... 6
4.2 次要疗效指标 ..................................................................................................................... 6
4.3 安全性指标 ......................................................................................................................... 6
5. .................................................................................................... 7
6. .................................................................................................... 7
6.1 一般原则 ............................................................................................................................. 7
6.2 病例特征 ............................................................................................................................. 7
6.3 疗效评价 ............................................................................................................................. 8
6.4 安全性评价 ......................................................................................................................... 9
7. .......................................................................................... 10
8. ................................................................................................... 11
8.1 病例特征 ........................................................................................................................... 11
8.1.1 病例分布 ............................................................................................................. 11
8.1.2 受试者一般信息 ................................................................................................. 12
8.2 疗效评价 ........................................................................................................................... 15
8.2.1 主要疗效 ............................................................................................................. 15
8.2.1.1 ......................................................................................... 15
8.2.2 次要疗效 ............................................................................................................. 17
8.2.2.1 ......................................................................................... 17
8.2.2.2 ................................................................................. 17
8.2.2.3 ......................................................................................... 18
8.2.2.4 ......................................................................................... 19
8.2.2.5 ......................................................................................... 20
8.2.2.6 ................................................................................................. 23
8.2.2.7 ......................................................................................... 25
8.2.3 亚组分析 ............................................................................................................. 27
8.2.3.1 ......................................................................................... 27
8.2.3.1.1 ................................................................................. 27
8.2.3.1.2 ................................................................................. 27
8.2.3.1.3 ......................................................................... 27
8.2.3.2 ......................................................................................... 27
8.2.3.2.1 ................................................................................. 27
8.2.3.2.2 ................................................................................. 27
8.2.3.2.3 ......................................................................... 27