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PROBLEM: different endpoints in corresponding grade may
reflect different biological mechanisms and/or organs at risk
Composed endpoints
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Mild diarrhea
Mild cramping
Bowel
movement 5
times daily
Slight rectal
discharge or
bleeding
Moderate
diarrhea and
colic
Bowel
movement >5
times daily
Excessive
rectal mucus or
intermittent
bleeding
Obstruction or
bleeding
requiring
surgery
Necrosis/
Perforation
Fistula
Death