27 11 SUBJECT ELIGIBILITY ............................................................................................................... 27 11.1 Inclusion Criteria .................................................................................................................. 27 11.2 Exclusion Criteria ................................................................................................................ 28 12 SCREENING AND ON -STUDY TESTS AND PROCEDURES .................................................. 28 12.1 Screening ............................................................................................................................ 33 12.2 Treatment Period ................................................................................................................. 33 12.3 End of Treatment ................................................................................................................. 33 12.4 Follow -up Period ................................................................................................................. 33 12.5 End of Study ........................................................................................................................ 33 12.6 Early Withdrawal of Subject(s) ............................................................................................ 33 12.6.1 Criteria for Early Withdrawal ....................................................................................... 33 12.6.2 Follow -up Requirements for Early Withdrawal ............................................................ 34 12.6.3 Replacement of Early Withdrawal(s) ........................................................................... 34 12.7 Study Assessments ............................................................................................................. 34 12.7.1 Medical History ............................................................................................................ 34 12.7.2 Physical Exam ............................................................................................................. 34 12.7.3 Use of Antihistamines .................................................................................................. 34 12.7.4 Radiologic Evaluations ................................................................................................ 35 12.8 Risk/Benefit Assessment .................................................................................................... 35 12.8.1 Potential Benefits ........................................................................................................ 35 12.8.2 Potential Risks ............................................................................................................. 35 13 SAFETY MONITORING AND REPORTING ............................................................................... 37 13.1 Adverse Events ................................................................................................................... 37 13.1.1 Reporting of AEs ......................................................................................................... 38 13.2 Serious Adverse Events ...................................................................................................... 38 13.2.1 Reporting of SAEs ....................................................................................................... 38 13.3 Safety Oversight Committee ............................................................................................... 38 14 QUALITY CONTROL AND QUALITY ASSURANCE .................................................................. 39 14.1 Monitoring ............................................................................................................................ 39 14.2 Audits .................................................................................................................................. 39 14.3 Data Management and Processing ..................................................................................... 39 14.3.1 Study Documentation .................................................................................................. 39 14.3.2 Data Management ....................................................................................................... 40 14.3.3 Data Management and Data Verification .................................................................... 40 14.3.4 Coding of Adverse Events ........................................................................................... 40 14.3.5 Study Closure .............................................................................................................. 40 15 STATISTICAL METHODS AND DATA ANALYSIS .................................................................... 41 Pro00054746: RESIST Study Version: 20171011 PT-PhI-II v05.22.12 Duke Cancer Institute Page 4 CONFIDENTIAL 15.1 Analysis Sets ....................................................................................................................... 41 15.2 Patient Demographics and Other Baseline Characteristics ................................................