Quantitative Methods 2017

• 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