Common Toxicity Criteria (CTC) for Gastrointestinal Adverse Events Associated with Cancer Therapy

anorexia

none

0

loss of appetite

1

oral intake significantly decreased

2

requires IV fluids

3

requires feeding tube OR parenteral nutrition

4

ascites, non-malignant

none

0

asymptomatic

1

symptomatic, requires diuretics

2

symptomatic, requires therapeutic paracentesis

3

life-threatening physiologic consequences

4

colitis

none

0

abdominal pain with mucus and/or blood in stool

2

abdominal pain, fever, change in bowel habits with ileus or peritoneal signs; radiographic or biopsy documentation

3

perforation or requiring surgery or toxic megacolon

4

constipation

none

0

requires stool softener or dietary modification

1

requires laxatives

2

obstipation requiring manual evacuation or enema

3

obstruction or toxic megacolon

4

dehydration

none

0

dry mucous membranes or diminished skin turgor

1

requires brief IV replacement

2

requires sustained IV replacement

3

hemodynamic collapse; physiologic changes requiring intensive care

4

diarrhea associated with GVHD in adult BMT

none

0

> 500 to <= 1,000 mL of diarrhea per day

1

> 1,000 to <= 1,500 mL of diarrhea per day

2

> 1,500 mL of diarrhea per day

3

severe abdominal pain with or without ileus

4

diarrhea associated with GVHD in pediatric BMT

none

0

> 5 to <= 10 mL per kg of diarrhea per day

1

> 10 to <= 15 mL per kg of diarrhea per day

2

> 15 mL per kg of diarrhea per day

3

severe abdominal pain with or without ileus

4

diarrhea, without colostomy

none

0

increase < 4 stools per day over pretreatment levels

1

increase 4 - 6 per day over pretreatment levels, or nocturnal stools

2

increase >= 7 stools per day or incontinence or need for parenteral support for dehydration

3

hemodynamic collapse; physiologic changes requiring intensive care

4

diarrhea with colostomy

none

0

mild increase in loose, watery output compared with pretreatment

1

moderate increase in loose, watery output compared to pretreatment, does not interferes with normal activity

2

severe increase in loose, watery output compared to pretreatment, interferes with normal activity

3

hemodynamic collapse; physiologic changes requiring intensive care

4

duodenal ulcer

none

0

requires medical management or nonsurgical treatment

2

uncontrolled by outpatient medical management; requires hospitalization

3

perforation or bleeding; requires emergency surgery

4

dyspepsia/heartburn

none

0

mild

1

moderate

2

severe

3

dysphagia, esophagitis, odynophagia

none

0

mild dysphagia, but can eat a regular diet

1

requires predominantly pureed, soft or liquid diet

2

requires IV hydration

3

complete obstruction (unable to swallow saliva); requires enteral or parenteral nutritional support; or perforation

4

dysphagia, esophageal, related to radiation

none

0

mild dysphagia, but can eat a regular diet

1

requires predominantly pureed, soft or liquid diet

2

requires feeding tube, IV hydration or hyperalimentation

3

complete obstruction (unable to swallow saliva); ulceration with bleeding not induced by minor trauma or abrasion; or perforation

4

dysphagia, pharyngeal, related to radiation

none

0

mild dysphagia, but can eat a regular diet

1

requires predominantly pureed, soft or liquid diet

2

dysphagia requiring feeding tube, IV hydration, or hyperalimentation

3

complete obstruction (unable to swallow saliva); ulceration with bleeding not induced by minor trauma or abrasion; or perforation

4

fistula, esophageal

none

0

present

3

requires surgery

4

fistula, intestinal

none

0

present

3

requires surgery

4

fistula, pharyngeal

none

0

present

3

requires surgery

4

fistula, rectal/anal

none

0

present

3

requires surgery

4

flatulence

none

0

mild

1

moderate

2

gastric ulcer

none

0

requires medical management or nonsurgical treatment

2

bleeding without perforation; uncontrolled by outpatient medical management; requires hospitalization or surgery

3

perforating or bleeding requiring emergency surgery

4

gastritis

none

0

requires medical management or nonsurgical treatment

2

uncontrolled by outpatient medical management; requires hospitalization or surgery

3

perforating or bleeding requiring emergency surgery

4

ileus

none

0

intermittent, not requiring intervention

2

requiring non-surgical intervention

3

requires surgery

4

mouth dryness

normal

0

mild

1

moderate

2

mucositis with radiation

none

0

erythema of the mucosa

1

patchy pseudomembranous reaction (noncontiguous, <= 1.5 cm in diameter)

2

confluent pseudomembranous reaction (contiguous and > 1.5 cm in diameter)

3

necrosis or deep ulceration; may include bleeding not induced by minor trauma or abrasion

4

nausea

none

0

able to eat

1

oral intake significantly decreased

2

no significant intake; requires IV fluids

3

pancreatitis

none

0

abdominal pain with pancreatic enzyme elevation

3

complicated by shock

4

proctitis

none

0

increased stool frequency, occasional blood-streaked stools or rectal discomfort (including hemorrhoids) not requiring medication

1

increased stool frequency, bleeding, mucus discharge or rectal discomfort requiring medication; anal fissure

2

increased stool frequency or diarrhea requiring parenteral support; rectal bleeding requiring transfusion; persistent mucus discharge requiring pads

3

perforation, bleeding or necrosis or other life-threatening complication requiring surgical intervention

4

salivary gland changes

none

0

slightly thickened saliva; may have slightly altered taste; additional fluids may be required

1

thick, ropy, sticky saliva; markedly altered taste; alteration in diet required

2

acute necrosis

4

sense of smell

normal

0

slightly altered

1

markedly altered

2

stomatitis, pharyngitis (oral or pharyngeal mucositis)

none

0

painless ulcers, erythema or mild soreness in the absence of lesions

1

painful erythema, edema or ulcers but can eat and swallow

2

painful erythema, edema or ulcers, requires IV hydration

3

severe ulceration or requires parenteral or enteral nutrition or prophylactic intubation

4

stomatitis, pharyngitis in BMT

none

0

painless ulcers, erythema or mild soreness in the absence of lesions

1

painful erythema, edema or ulcers but can swallow

2

painful erythema, edema or ulcers that prevent swallowing or requiring hydration or parenteral or enteral nutritional support

3

severe ulceration requiring prophylactic intubation or resulting in documented aspiration pneumonia

4

taste disturbance

normal

0

slightly altered

1

markedly altered

2

typhilitis (inflammation of cecum)

none

0

abdominal pain, fever, diarrhea; radiographic or biopsy documentation

3

perforation, bleeding, necrosis or life-threatening complication requiring surgical intervention

4

vomiting

none

0

1 episode in 24 hours over pretreatment

1

2-5 episodes in 24 hours after pretreatment

2

>= 6 episodes in 24 hours after pretreatment, OR need for IV fluids

3

requires parenteral nutrition OR hemodynamic collapse OR physiologic consequences requiring ICU care

4

GI, other

none

0

mild

1

moderate

2

severe

3

life-threatening or disabling

4