| Severity grading |
Diarrhea |
Nausea |
Vomiting |
| Grade I |
Increased stool frequency compared to baseline <4 times/day, mild increase in fistula exclusion compared to baseline. |
Decreased appetite and no change in eating habits. |
One to two episodes within 24 hours at 5 min intervals. |
| Grade II |
Fecal frequency increased 4 to 6 episodes/day from baseline, IV rehydration less than 24 hours, moderate increase in fistula excretion compared to baseline. |
Decreased transoral intake without significant weight loss, dehydration, or malnutrition. |
3 to 5 episodes 5 minutes apart in 24 hours. |
| Grade III |
Fecal frequency increased by 7 episodes/day from baseline, with fecal incontinence requiring hospitalization. Heavy increase in fistula exclusion from baseline compared to baseline, affecting the patient’s personal activities of daily living. |
Insufficient oral intake of energy and water, requiring nasal feeding, total parenteral nutrition, or hospital admission. |
6 episodes within 24 hours at 5-minute intervals requiring nasal feeding, total parenteral nutrition, or hospital admission. |
| Grade IV |
Life-threatening, requiring urgent treatment. |
– |
Life-threatening, requiring urgent treatment. |
| Class V |
Death |
– |
Death |
Note: Grading criteria are based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 4.0).