446 / 1778
Adverse Effects
• Arm A - More Grade 3-4 toxicities (p<0.001)
• Haematologic Toxicity
–
Grade 3-4 ; 71.9% Vs 23.9 %
• Non haematologic toxicities
– Vomiting & diarrhea more in arm A (p=0.002)
• Hospitalization during treatment
– Arm A -30 pts & Arm B -11 pts (p=0.02)
– 3 deaths in arm A – 2 due to sepsis and bowel perforation & 1 due to
acute encephalopathy
• Late toxicities slightly higher in Arm A
–
Grade 4 GI : 2.3 % Vs 0%