........ 7 6.0 DEMOGRAPHIC AND BASELINE CHARACTERISTICS ........................... 8 6.1 Demographic Characteristics ............................................................... 8 6.2 Medical History ................................................................................... 8 6.3 Prior and Concomitant Medications and Procedures .............................. 9 7.0 EFFICACY ANALYSIS ................................ ................................ ........... 9 7.1 Response Rate ................................................................................... 9 7.2 Objective Response Rate (ORR) .......................................................... 9 7.3 Disease Control Rate (DCR) .............................................................. 10 7.4 Progression -free Survival (PFS) ......................................................... 10 7.5 Overall Survival (OS) ........................................................................ 11 7.6 Duration of Response (DoR) .............................................................. 11 7.7 Analysis of Time to Event (TTE) Variables .......................................... 11 8.0 TRIAL DRUG EXPOSURE AND COMPLIANCE ................................ ..... 12 9.0 SAFETY ANALYSIS ................................ ................................ ............ 12 9.1 Adverse Events ................................................................................ 12 9.1.1 Treatment -Emergent Adverse Events ................................... 13 9.1.2 Adverse Events of Special Interest (AESIs) .......................... 15 9.2 Clinical Laboratory Data .................................................................... 15 9.3 Vital Signs and Weight ...................................................................... 17 9.4 Electrocardiograms ........................................................................... 17 9.5 ECOG Performance ........................................................................... 18 9.6 Physical Examinations ....................................................................... 18 9.7 Pregnancy Testing ............................................................................ 18 10.0 EXPLORATORY ANALYSIS ................................ ................................ 18 11.0 STA TISTICAL/ANALYTICAL ISSUES ................................ ................... 19 11.1 Handling of Dropouts or Missing Data ................................................ 19 11.2 Safety Data Handling ........................................................................ 19 11.3 Coding Dictionaries ........................................................................... 20 11.4 Pooling of Centers in Multi -Center Trials ............................................. 20 11.5 Multiple Comparisons/Multiplicity ....................................................... 20 11.6 Examination of Subgroups ................................................................ 20 11.7 Interim Analysis and Data Monitoring ................................................ 20 12.0 QUALITY CONTROL ................................ ................................