................................ 37 3.7 CRITERIA FOR REMOVAL FROM PROTOCOL THERAPY AND OFF STUDY CRITE RIA .............. 37 3.7.1 Criteria for removal from protocol therapy ................................ ................................ 37 3.7.2 Off-Study Criteria ................................ ................................ ................................ .......37 3.7.3 Off Protocol Therapy and Off -Study Procedure ................................ ......................... 37 4 CONCOMITANT MEDICATI ONS/MEASURES ................................ ................................ 38 4.1 CONCURRENT MEDICATIONS /INTERVENTIONS ................................ ................................ ....38 4.1.1 Anticancer Therapy ................................ ................................ ................................ ....38 4.1.2 Other Medications ................................ ................................