The Common Toxicity Criteria (CTC) define adverse events following cancer therapy. It was designed for use in clinical trials of different therapeutic regimens.
Types of adverse renal or genitourinary events:
(1) bladder spasms
(2) serum creatinine
(3) dysuria
(4) fistula or genitourinary fistula
(5) hemoglobinuria
(6) incontinence
(7) operative injury to the bladder and/or ureter
(8) proteinuria
(9) renal failure
(10) ureteral obstruction
(11) urinary electrolyte wasting (renal tubular acidosis, Fanconi's anemia)
(12) urinary frequency or urgency
(13) urinary retention
(14) urine color change
(15) vaginitis
(16) other renal or genitourinary complications
NOTE: Vaginal bleeding and hematuria are graded with Hemorrhagic adverse events.
Complication |
Finding |
Grade |
---|---|---|
bladder spasm |
none |
0 |
|
mild symptoms, not requiring intervention |
1 |
|
symptoms requiring antispasmodic agents |
2 |
|
severe symptoms requiring narcotic analgesic |
3 |
serum creatinine |
within normal limit |
0 |
|
> upper limit of normal (ULN) and <= 1.5 times ULN |
1 |
|
> 1.5 times ULN and <= 3.0 times ULN |
2 |
|
> 3 times ULN and <= 6.0 times ULN |
3 |
|
> 6 times ULN |
4 |
dysuria |
none |
0 |
|
mild symptoms not requiring an intervention |
1 |
|
symptomatic, relieved with therapy |
2 |
|
symptoms not relieved with therapy |
3 |
fistula |
none |
0 |
|
requires intervention |
3 |
|
requires surgical repair |
4 |
hemoglobinuria |
absent |
0 |
|
present |
1 |
incontinence |
none |
0 |
|
with coughing, sneezing, etc. |
1 |
|
spontaneous, with some control |
2 |
|
no control (in the absence of a fistula) |
3 |
operative injury |
none |
0 |
|
injury to bladder with primary repair |
2 |
|
sepsis, fistula, or obstruction requiring secondary surgery; loss of one kidney; injury requiring anastomosis or re-implantation |
3 |
|
septic obstruction of both kidneys or vesicovaginal fistula requiring diversion |
4 |
proteinuria |
< 0.15 g per 24 hours |
0 |
|
0.15 to 1.0 g per 24 hours (or 1+ on dipstick) |
1 |
|
1.01 to 3.5 g per 24 hours (or 2-3+ on dipstick) |
2 |
|
> 3.5 g per 24 hours (4+ on dipstick) |
3 |
|
nephrotic syndrome |
4 |
renal failure |
none |
0 |
|
requires dialysis but reversible |
3 |
|
requires dialysis and irreversible |
4 |
ureteral obstruction |
none |
0 |
|
unilateral, not requiring surgery |
1 |
|
bilateral, not requiring surgery |
3 |
|
requires stent, nephrostomy tube, or surgery |
4 |
urinary electrolyte wasting |
none |
0 |
|
asymptomatic, not requiring therapy |
1 |
|
mild, reversible and manageable with oral replacement |
2 |
|
reversible but requires IV replacement |
3 |
|
irreversible, requiring continuous replacement |
4 |
urinary frequency or urgency |
normal |
0 |
|
increase in frequency or nocturia up to 2 times normal |
1 |
|
increase more than 2 times normal but less than hourly |
2 |
|
hourly or more frequently with urgency, or requires catheter |
3 |
urinary retention |
none |
0 |
|
hesitancy or dribbling but no significant residual urine; retention occurs during the immediate post-operative period |
1 |
|
hesitancy requiring medication or occasional in/out catheterization, or operative bladder atony requiring indwelling catheter beyond immediate postoperative period but for less than t weeks |
2 |
|
requires frequent in/out catheterization (4 or more times per week) or urological intervention (TURP, suprapubic tube, urethrotomy) |
3 |
|
bladder rupture |
4 |
urine color change |
normal |
0 |
|
asymptomatic change in color (not due to bilirubin, hematuria, or concentration) |
1 |
vaginitis |
none |
0 |
|
mild, not requiring therapy |
1 |
|
moderate, relieved with therapy |
2 |
|
severe, not relieved by therapy, or ulceration not requiring surgery |
3 |
|
ulceration requiring surgery |
4 |
other renal or GU adverse event |
none |
0 |
|
mild |
1 |
|
moderate |
2 |
|
severe |
3 |
|
life-threatening or disabling |
4 |
Specialty: Hematology Oncology, Nephrology