values laboratory following adequate organ clinical function screening specified days 
organ function adequate defined follows protocol criteria following days baseline 
hematologic end organ function adequate days study treatment initiation obtained 
organ function adequate including demonstrates baseline days following evidenced registration 
female subject eligible defined enter amenorrhea follows childbearing participate potential 
impaired cardiac function following including problems history protocol defined known 
meeting criteria following disease measurable defined iwcll function adequate hematologic 
renal function adequate liver acceptable defined follows following cardiac days 
organ marrow function adequate defined requirements follows subjects patient protocol 
parameters laboratory range protocol defined adequate acceptable meet medical following 
hepatic function adequate encephalopathy defined follows evidenced history dysfunction met