22 5.2.5 Other Safety Endpoints ........................................................................................... 22 6 ANALYSIS SETS ................................................................................................................ 22 6.1 ITT Set ............................................................................................................................ 23 6.2 EE Set ............................................................................................................................. 23 6.3 Safety Set ........................................................................................................................ 23 7 GENERAL STATISTICAL CONSIDERATIONS .............................................................. 23 7.1 Data Summaries and Conventions ................................................................................. 23 7.2 Study Day ....................................................................................................................... 24 7.3 Handling of Dropouts or Missing Data .......................................................................... 24 7.3.1 Partial Dates for Adverse Events ............................................................................ 24 7.3.2 Partial Dates for Concomitant Medication ............................................................. 24 7.4 Multiplicity ..................................................................................................................... 25 7.5 Interim Analyses and Data Monitoring .......................................................................... 25 8 STATISTICAL ANALYSIS ................................................................................................ 26 8.1 Study Population ............................................................................................................ 26 8.1.1 Subject Disposition ................................................................................................. 26 8.1.2 Protocol Deviations ................................................................................................. 26 8.1.3 Demographic and Baseline Characteristics ............................................................ 26 8.2 Efficacy Analyses ........................................................................................................... 27 8.2.1 Analysis of Primary Efficacy Variables ................................................................. 27 8.2.1.1 Primary Analysis ................................................................................................. 28 8.2.1.2 Sensitive Analysis of Primary Endpoints (PFS/OS) ........................................... 28 8.2.2 Analysis of Secondary Efficacy Variables ............................................................. 30 8.2.2.1 Time to Next Treatment (TTNT) ........................................................................ 30 8.2.2.2 Distant Metastasis -Free Survival (DMFS) .......................................................... 31 8.2.2.3 Objective Response Rate (ORR ) ......................................................................... 31 8.2.2.4 QoL using the EQ -5D-5L or EQ -5D-Y............................................................... 31 8.2.3 Analysis of Exploratory Efficacy Variables ...........................................................