8. NCIC CTCAE Toxicity scoring.
Symptom | Grade I | Grade II | Grade III | Grade IV | Grade V |
Gastrointestinal | |||||
Anorexia | — | — | — | — | — |
Diarrhea | Increase of < 4 stools per day over baseline Increase in ostomy output |
Increase of 4–6 stools per day over baseline Moderate increase in ostomy output compared to baseline |
Increase of 7 stools per day over baseline Incontinence Hospitalization indicated Severe increase in ostomy output compared to baseline |
Life‐threatening consequences Urgent intervention indicated |
Death |
Gastrointestinal bleeding | Mild symptoms Intervention not indicated |
Moderate symptoms Medical intervention or minor cauterization indicated |
Transfusion, radiologic, endoscopic or elective operative intervention indicated | Life‐threatening consequences Urgent intervention indicated |
Death |
Nausea | Loss of appetite without alteration in eating habits | Oral intake decreased without significant weight loss, dehydration or malnutrition | Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated | — | — |
Pain/cramping | Mild pain | Moderate pain Limiting instrumental ADL |
Severe pain Limiting self‐care ADL |
— | — |
Vomiting | 1–2 episodes (separated by 5 minutes) in 24 hours | 3–5 episodes (separated by 5 minutes) in 24 hours | ≥ 6 episodes (separated by 5 minutes) in 24 hours Tube feeding, TPN or hospitalization indicated |
Life‐threatening consequences Urgent intervention indicated |
Death |
Bladder changes | |||||
Cystitis | Microscopic hematuria Minimal increase in frequency, urgency, dysuria or nocturia New‐onset incontinence |
Moderate hematuria Moderate increase in frequency, urgency, dysuria, nocturia or incontinence Urinary catheter placement or bladder irrigation indicated Limiting instrumental ADL |
Gross hematuria Transfusion, IV medications or hospitalization indicated Elective endoscopic, radiologic or operative intervention indicated |
Life‐threatening consequences Urgent radiologic or operative intervention indicated |
Death |
Fistula | — | Non‐invasive intervention indicated Urinary or suprapubic catheter placement indicated |
Limiting self‐care ADL Elective radiologic, endoscopic or operative intervention indicated Permanent urinary diversion indicated |
Life‐threatening consequences Urgent radiologic or operative intervention indicated |
Death |
Genitourinary pain | Mild pain | Moderate pain Limiting instrumental ADL |
Severe pain Limiting self‐care ADL |
— | — |
Hematuria | Asymptomatic Clinical or diagnostic observations only Intervention not indicated |
Symptomatic Urinary catheter or bladder irrigation indicated Limiting instrumental ADL |
Gross hematuria Transfusion, IV medications or hospitalization indicated Elective endoscopic, radiologic or operative intervention indicated Limiting self‐care ADL |
Life‐threatening consequences Urgent radiologic or operative intervention indicated |
— |
Ureteric obstruction | Asymptomatic Clinical or diagnostic observations only |
Symptomatic but no hydronephrosis, sepsis or renal dysfunction Urethral dilation, urinary or suprapubic catheter indicated |
Symptomatic and altered organ function (e.g. hydronephrosis or renal dysfunction) Elective radiologic, endoscopic or operative intervention indicated |
Life‐threatening consequences Urgent intervention indicated |
— |
ADL: activities of daily living; IV: intravenous; NCIC CTCAE: National Cancer Information Center Common Terminology Criteria for Adverse Events; TPN: total parenteral nutrition.