Grades of GI adverse effect according to National Common Terminology Criteria for Adverse Events V.4.0
| Adverse effect | Grade | |||
| 1 | 2 | 3 | 4 | |
| Diarrhoea | Increase of <4 stools per day over baseline; mild increase in ostomy output compared with baseline. | Increase of 4–6 stools per day over baseline; moderate increase in ostomy output compared with baseline. | Increase of ≥7 stools per day over baseline; incontinence; hospitalisation indicated; severe increase in ostomy output compared with baseline; limiting self-care activity of daily living. | Life-threatening consequences; urgent intervention indicated (eg, haemodynamic collapse). |
| Colitis | Asymptomatic; clinical or diagnostic observations only; intervention not indicated. | Abdominal pain; mucus or blood in stool. | Severe or persistent abdominal pain; change in bowel habits; fever; ileus medical intervention indicated; peritoneal signs. | Life-threatening consequences; urgent intervention indicated (eg, perforation, bleeding, ischaemia, necrosis, toxic megacolon). |