CTCAE RápidoAdverse event grades · CTCAE v6.0
Código Onco

Gastrointestinal disorders

The 122 CTCAE v6.0 adverse events in Gastrointestinal disorders, with grades 1 to 5.

Abdominal distension

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe discomfort; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by swelling of the abdomen.

MedDRA code (LLT): 10000060 · CTCAE v6.0 (NCI), original English text.

Abdominal pain

Gastrointestinal disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the abdominal region.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10000081 · CTCAE v6.0 (NCI), original English text.

Anal fissure

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic
  3. G3Invasive intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a tear in the lining of the anus.

MedDRA code (LLT): 10002153 · CTCAE v6.0 (NCI), original English text.

Anal fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the opening in the anal canal to the perianal skin.

MedDRA code (LLT): 10002156 · CTCAE v6.0 (NCI), original English text.

Anal mucositis

Gastrointestinal disorders
  1. G1Asymptomatic or mild symptoms; intervention not indicated
  2. G2Moderate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by ulceration or inflammation of the mucous membrane of the anus.

Navigational noteReport Grade 4 and 5 as Gastrointestinal disorders: Anal ulcer.

MedDRA code (LLT): 10065721 · CTCAE v6.0 (NCI), original English text.

Anal necrosis

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3TPN or hospitalization indicated; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a necrotic process occurring in the anal region.

MedDRA code (LLT): 10065722 · CTCAE v6.0 (NCI), original English text.

Anal pain

Gastrointestinal disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the anal region.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10002167 · CTCAE v6.0 (NCI), original English text.

Anal stenosis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Symptomatic and severely altered GI function; non-emergent operative intervention indicated; TPN or hospitalization indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a narrowing of the lumen of the anal canal.

MedDRA code (LLT): 10002176 · CTCAE v6.0 (NCI), original English text.

Anal ulcer

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Severely altered GI function; TPN indicated; elective invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the anal canal.

MedDRA code (LLT): 10002180 · CTCAE v6.0 (NCI), original English text.

Ascites

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; medical intervention or paracentesis indicated
  3. G3Severe symptoms; catheter placement indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by accumulation of serous or hemorrhagic fluid in the peritoneal cavity.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10003445 · CTCAE v6.0 (NCI), original English text.

Belching

Gastrointestinal disorders
  1. G1Increase from baseline
  2. G2Intervention initiated (including over the counter medications)
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionTo expel gas noisily from the mouth.

Navigational noteSynonym: Burping

MedDRA code (LLT): 10004222 · CTCAE v6.0 (NCI), original English text.

Bloating

Gastrointestinal disorders
  1. G1No change in bowel function or oral intake
  2. G2Symptomatic, decreased oral intake; change in bowel function
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by subject-reported feeling of uncomfortable fullness of the abdomen.

MedDRA code (LLT): 10005265 · CTCAE v6.0 (NCI), original English text.

Cecal hemorrhage

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the cecum.

MedDRA code (LLT): 10065747 · CTCAE v6.0 (NCI), original English text.

Cheilitis

Gastrointestinal disorders
  1. G1Clinical or diagnostic observations only; intervention not indicated
  2. G2Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by inflammation of the lip.

MedDRA code (LLT): 10008417 · CTCAE v6.0 (NCI), original English text.

Chylous ascites

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; medical intervention indicated (e.g., fat-restricted diet); paracentesis or tube drainage indicated
  3. G3Severe symptoms; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by accumulation of milky fluid in the peritoneal cavity.

MedDRA code (LLT): 10009167 · CTCAE v6.0 (NCI), original English text.

Colitis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Abdominal pain; mucus or blood in stool
  3. G3Severe abdominal pain; peritoneal signs
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation of the colon.

MedDRA code (LLT): 10009887 · CTCAE v6.0 (NCI), original English text.

Colonic fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the large intestine and another organ or anatomic site.

MedDRA code (LLT): 10009995 · CTCAE v6.0 (NCI), original English text.

Colonic obstruction

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Hospitalization indicated; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by blockage of the normal flow of the intestinal contents in the colon.

MedDRA code (LLT): 10010000 · CTCAE v6.0 (NCI), original English text.

Colonic perforation

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the colonic wall.

Navigational noteConsider Gastrointestinal disorders: Colitis.

MedDRA code (LLT): 10010001 · CTCAE v6.0 (NCI), original English text.

Colonic stenosis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a narrowing of the lumen of the colon.

MedDRA code (LLT): 10010004 · CTCAE v6.0 (NCI), original English text.

Colonic ulcer

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Severely altered GI function; TPN indicated; elective invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the colon.

MedDRA code (LLT): 10010006 · CTCAE v6.0 (NCI), original English text.

Constipation

Gastrointestinal disorders
  1. G1Occasional or intermittent symptoms; occasional use of stool softeners, laxatives, dietary modification, or enema
  2. G2Persistent symptoms with regular use of laxatives or enemas; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Obstipation with manual evacuation indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by irregular and infrequent or difficult evacuation of the bowels.

MedDRA code (LLT): 10010774 · CTCAE v6.0 (NCI), original English text.

Dental caries

Gastrointestinal disorders
  1. G1One or more dental caries, not involving the root
  2. G2Dental caries involving the root
  3. G3Dental caries resulting in pulpitis or periapical abscess or resulting in tooth loss
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by the decay of a tooth, in which it becomes softened, discolored and/or porous.

MedDRA code (LLT): 10012318 · CTCAE v6.0 (NCI), original English text.

Diarrhea

Gastrointestinal disorders
  1. G1Change in consistency or frequency
  2. G2Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric); change in consistency or frequency AND limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Increase of >=7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; requires IV intervention; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an increase in frequency and/or loose or watery bowel movements.

Navigational noteConsider Gastrointestinal disorders: Colitis, Enterocolitis.

MedDRA code (LLT): 10012727 · CTCAE v6.0 (NCI), original English text.

Dry mouth

Gastrointestinal disorders
  1. G1Symptomatic (e.g., dry or thick saliva) without significant dietary alteration; unstimulated saliva flow >0.2 ml/min
  2. G2Moderate symptoms; oral intake alterations (e.g., copious water, other lubricants, diet limited to purees and/or soft, moist foods); unstimulated saliva 0.1 to 0.2 ml/min
  3. G3Inability to adequately aliment orally; tube feeding or TPN indicated; unstimulated saliva <0.1 ml/min
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by reduced salivary flow in the oral cavity.

Navigational noteIf related to syndromes not present in CTCAE (ex. Sjogren's syndrome, etc.), report as Other, specify in the most representative SOC.

MedDRA code (LLT): 10013781 · CTCAE v6.0 (NCI), original English text.

Duodenal fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the duodenum and another organ or anatomic site.

MedDRA code (LLT): 10013828 · CTCAE v6.0 (NCI), original English text.

Duodenal hemorrhage

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the duodenum.

Navigational noteConsider Gastrointestinal disorders: Enterocolitis.

MedDRA code (LLT): 10055242 · CTCAE v6.0 (NCI), original English text.

Duodenal obstruction

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Hospitalization indicated; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by blockage of the normal flow of stomach contents through the duodenum.

MedDRA code (LLT): 10013830 · CTCAE v6.0 (NCI), original English text.

Duodenal perforation

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the duodenal wall.

Navigational noteConsider Gastrointestinal disorders: Enterocolitis.

MedDRA code (LLT): 10013832 · CTCAE v6.0 (NCI), original English text.

Duodenal stenosis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a narrowing of the lumen of the duodenum.

MedDRA code (LLT): 10050094 · CTCAE v6.0 (NCI), original English text.

Duodenal ulcer

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the duodenal wall.

MedDRA code (LLT): 10013836 · CTCAE v6.0 (NCI), original English text.

Dyspepsia

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; medical intervention indicated
  3. G3Severe symptoms; operative intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an uncomfortable, often painful feeling in the stomach, resulting from impaired digestion. Symptoms include burning stomach, bloating, heartburn, nausea and vomiting.

Navigational noteConsider Gastrointestinal disorders: Gastritis, Gastroparesis.

MedDRA code (LLT): 10013946 · CTCAE v6.0 (NCI), original English text.

Dysphagia

Gastrointestinal disorders
  1. G1Symptomatic, able to eat regular diet
  2. G2Symptomatic and altered eating/swallowing
  3. G3Severely altered eating/swallowing; tube feeding, TPN, or hospitalization indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by difficulty in swallowing.

MedDRA code (LLT): 10013950 · CTCAE v6.0 (NCI), original English text.

Enterocolitis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Abdominal pain; mucus or blood in stool
  3. G3Severe or persistent abdominal pain; fever; ileus; peritoneal signs
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation of the small and large intestines.

Navigational noteIf reporting a known abnormality of the colon, use Gastrointestinal disorders: Colitis. If reporting a documented infection, use Infections and infestations: Enterocolitis infectious.

MedDRA code (LLT): 10014893 · CTCAE v6.0 (NCI), original English text.

Enterovesical fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the urinary bladder and the intestine.

MedDRA code (LLT): 10062570 · CTCAE v6.0 (NCI), original English text.

Esophageal fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the esophagus and another organ or anatomic site.

MedDRA code (LLT): 10065851 · CTCAE v6.0 (NCI), original English text.

Esophageal hemorrhage

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the esophagus.

MedDRA code (LLT): 10015384 · CTCAE v6.0 (NCI), original English text.

Esophageal necrosis

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Inability to aliment adequately by GI tract; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a necrotic process occurring in the esophageal wall.

MedDRA code (LLT): 10065727 · CTCAE v6.0 (NCI), original English text.

Esophageal obstruction

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by blockage of the normal flow of the contents in the esophagus.

MedDRA code (LLT): 10015387 · CTCAE v6.0 (NCI), original English text.

Esophageal pain

Gastrointestinal disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the esophageal region.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10015388 · CTCAE v6.0 (NCI), original English text.

Esophageal perforation

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the wall of the esophagus.

MedDRA code (LLT): 10055472 · CTCAE v6.0 (NCI), original English text.

Esophageal stenosis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a narrowing of the lumen of the esophagus.

MedDRA code (LLT): 10015448 · CTCAE v6.0 (NCI), original English text.

Esophageal ulcer

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the esophageal wall.

MedDRA code (LLT): 10015451 · CTCAE v6.0 (NCI), original English text.

Esophageal varices hemorrhage

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Self-limited; intervention not indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from esophageal varices.

MedDRA code (LLT): 10015453 · CTCAE v6.0 (NCI), original English text.

Esophagitis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered eating/swallowing; oral supplements indicated
  3. G3Severely altered eating/swallowing; tube feeding, TPN, or hospitalization indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation of the esophageal wall.

MedDRA code (LLT): 10015461 · CTCAE v6.0 (NCI), original English text.

Fecal incontinence

Gastrointestinal disorders
  1. G1Occasional use of pads required
  2. G2Daily use of pads required
  3. G3Severe symptoms; elective operative intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by inability to control the escape of stool from the rectum.

MedDRA code (LLT): 10016296 · CTCAE v6.0 (NCI), original English text.

Flatulence

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate; persistent; psychosocial sequelae
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a discharge of excessive gas from the lower GI tract.

MedDRA code (LLT): 10016766 · CTCAE v6.0 (NCI), original English text.

Gastric fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the stomach and another organ or anatomic site.

MedDRA code (LLT): 10065713 · CTCAE v6.0 (NCI), original English text.

Gastric hemorrhage

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the gastric wall.

MedDRA code (LLT): 10017789 · CTCAE v6.0 (NCI), original English text.

Gastric necrosis

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Inability to aliment adequately by GI tract; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a necrotic process occurring in the gastric wall.

MedDRA code (LLT): 10051886 · CTCAE v6.0 (NCI), original English text.

Gastric perforation

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the stomach wall.

MedDRA code (LLT): 10017815 · CTCAE v6.0 (NCI), original English text.

Gastric stenosis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a narrowing of the lumen of the stomach.

MedDRA code (LLT): 10061970 · CTCAE v6.0 (NCI), original English text.

Gastric ulcer

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the stomach.

MedDRA code (LLT): 10017822 · CTCAE v6.0 (NCI), original English text.

Gastritis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; medical intervention indicated
  3. G3Severely altered eating or gastric function; TPN or hospitalization indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation of the stomach.

MedDRA code (LLT): 10017853 · CTCAE v6.0 (NCI), original English text.

Gastroesophageal reflux disease

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; medical intervention indicated
  3. G3Severe symptoms; operative intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by reflux of the gastric and/or duodenal contents into the distal esophagus. It is chronic in nature and usually caused by incompetence of the lower esophageal sphincter, and may result in injury to the esophageal mucosal. Symptoms include heartburn and acid indigestion.

MedDRA code (LLT): 10066874 · CTCAE v6.0 (NCI), original English text.

Gastrointestinal disorders - Other, specify

Gastrointestinal disorders
  1. G1Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
  2. G2Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

MedDRA code (LLT): 10017947 · CTCAE v6.0 (NCI), original English text.

Gastrointestinal fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between any part of the gastrointestinal system and another organ or anatomic site.

MedDRA code (LLT): 10017877 · CTCAE v6.0 (NCI), original English text.

Gastrointestinal pain

Gastrointestinal disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the gastrointestinal region.

Navigational noteConsider Gastrointestinal disorders: Colitis, Enterocolitis. Record final diagnosis/cause once determined.

MedDRA code (LLT): 10017999 · CTCAE v6.0 (NCI), original English text.

Gastroparesis

Gastrointestinal disorders
  1. G1Mild nausea, early satiety and bloating, able to maintain caloric intake on regular diet
  2. G2Moderate symptoms; able to maintain nutrition with dietary and lifestyle modifications; may need pharmacologic intervention
  3. G3Weight loss >=20% from baseline; tube feeding or TPN indicated; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an incomplete paralysis of the muscles of the stomach wall resulting in delayed emptying of the gastric contents into the small intestine.

MedDRA code (LLT): 10018043 · CTCAE v6.0 (NCI), original English text.

Gingival pain

Gastrointestinal disorders
  1. G1Mild pain
  2. G2Moderate pain interfering with oral intake
  3. G3Severe pain; inability to aliment orally
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the gingival region.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10018286 · CTCAE v6.0 (NCI), original English text.

Hematemesis

Gastrointestinal disordersNew in v6.0
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by the vomiting of blood.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10019418 · CTCAE v6.0 (NCI), original English text.

Hematochezia

Gastrointestinal disordersNew in v6.0
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by the passage of fresh blood per anus, usually in or with stools.

Navigational noteConsider Gastrointestinal disorders: Colitis, Enterocolitis, Proctitis; Record final diagnosis/cause once determined.

MedDRA code (LLT): 10060544 · CTCAE v6.0 (NCI), original English text.

Hemorrhoidal hemorrhage

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the hemorrhoids.

MedDRA code (LLT): 10060640 · CTCAE v6.0 (NCI), original English text.

Hemorrhoids

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; banding or medical intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by the presence of dilated veins in the rectum and surrounding area.

MedDRA code (LLT): 10019611 · CTCAE v6.0 (NCI), original English text.

Ileal fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the ileum and another organ or anatomic site.

MedDRA code (LLT): 10065728 · CTCAE v6.0 (NCI), original English text.

Ileal hemorrhage

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the ileal wall.

Navigational noteConsider Gastrointestinal disorders: Enterocolitis.

MedDRA code (LLT): 10055287 · CTCAE v6.0 (NCI), original English text.

Ileal obstruction

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; naso-gastric tube indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Hospitalization indicated; invasive intervention indicated; long intestinal tube indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by blockage of the normal flow of the intestinal contents in the ileum.

MedDRA code (LLT): 10065730 · CTCAE v6.0 (NCI), original English text.

Ileal perforation

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the ileal wall.

Navigational noteConsider Gastrointestinal disorders: Enterocolitis.

MedDRA code (LLT): 10021305 · CTCAE v6.0 (NCI), original English text.

Ileal stenosis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a narrowing of the lumen of the ileum.

MedDRA code (LLT): 10021307 · CTCAE v6.0 (NCI), original English text.

Ileal ulcer

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Severely altered GI function; TPN indicated; elective invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the ileum.

MedDRA code (LLT): 10021309 · CTCAE v6.0 (NCI), original English text.

Ileus

Gastrointestinal disorders
  1. G1Asymptomatic and radiologic observations only
  2. G2Symptomatic; altered GI function; bowel rest indicated
  3. G3Severely altered GI function; TPN indicated; tube placement indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by failure of the ileum to transport intestinal contents.

MedDRA code (LLT): 10021328 · CTCAE v6.0 (NCI), original English text.

Intra-abdominal hemorrhage

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding in the abdominal cavity.

MedDRA code (LLT): 10055291 · CTCAE v6.0 (NCI), original English text.

Jejunal fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the jejunum and another organ or anatomic site.

MedDRA code (LLT): 10065719 · CTCAE v6.0 (NCI), original English text.

Jejunal hemorrhage

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the jejunal wall.

Navigational noteConsider Gastrointestinal disorders: Enterocolitis.

MedDRA code (LLT): 10055300 · CTCAE v6.0 (NCI), original English text.

Jejunal obstruction

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by blockage of the normal flow of the intestinal contents in the jejunum.

MedDRA code (LLT): 10065732 · CTCAE v6.0 (NCI), original English text.

Jejunal perforation

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the jejunal wall.

Navigational noteConsider Gastrointestinal disorders: Enterocolitis.

MedDRA code (LLT): 10023174 · CTCAE v6.0 (NCI), original English text.

Jejunal stenosis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a narrowing of the lumen of the jejunum.

MedDRA code (LLT): 10023176 · CTCAE v6.0 (NCI), original English text.

Jejunal ulcer

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Severely altered GI function; TPN indicated; elective invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the jejunum.

MedDRA code (LLT): 10023177 · CTCAE v6.0 (NCI), original English text.

Lip pain

Gastrointestinal disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort of the lip.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10024561 · CTCAE v6.0 (NCI), original English text.

Malabsorption

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Altered diet; oral intervention indicated
  3. G3Inability to aliment adequately; TPN indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by inadequate absorption of nutrients in the small intestine. Symptoms include abdominal marked discomfort, bloating and diarrhea.

MedDRA code (LLT): 10025476 · CTCAE v6.0 (NCI), original English text.

Melena

Gastrointestinal disordersNew in v6.0
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by black, tarry stools.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10027162 · CTCAE v6.0 (NCI), original English text.

Mucositis oral

Gastrointestinal disorders
  1. G1Asymptomatic or mild symptoms; intervention not indicated
  2. G2Moderate pain or ulcer that does not interfere with oral intake; modified diet indicated
  3. G3Severe pain; interfering with oral intake
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by ulceration or inflammation of the oral mucosal.

MedDRA code (LLT): 10028130 · CTCAE v6.0 (NCI), original English text.

Nausea

Gastrointestinal disorders
  1. G1Loss of appetite without alteration in eating habits
  2. G2Oral intake decreased without significant weight loss, dehydration or malnutrition; IV intervention indicated
  3. G3Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a queasy sensation and/or the urge to vomit.

Navigational noteConsider Gastrointestinal disorders: Enterocolitis, Gastritis and/or Endocrine disorders: Adrenal insufficiency, Hypophysitis.

MedDRA code (LLT): 10028813 · CTCAE v6.0 (NCI), original English text.

Obstruction gastric

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by blockage of the normal flow of the contents in the stomach.

MedDRA code (LLT): 10029957 · CTCAE v6.0 (NCI), original English text.

Oral cavity fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the oral cavity and another organ or anatomic site.

MedDRA code (LLT): 10065720 · CTCAE v6.0 (NCI), original English text.

Oral dysesthesia

Gastrointestinal disorders
  1. G1Mild discomfort; not interfering with oral intake
  2. G2Moderate pain; interfering with oral intake
  3. G3Disabling pain; tube feeding or TPN indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a burning or tingling sensation on the lips, tongue or entire mouth.

MedDRA code (LLT): 10054520 · CTCAE v6.0 (NCI), original English text.

Oral hemorrhage

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the mouth.

MedDRA code (LLT): 10030980 · CTCAE v6.0 (NCI), original English text.

Oral pain

Gastrointestinal disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the mouth, tongue or lips.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10031009 · CTCAE v6.0 (NCI), original English text.

Pancreatic duct stenosis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a narrowing of the lumen of the pancreatic duct.

MedDRA code (LLT): 10065703 · CTCAE v6.0 (NCI), original English text.

Pancreatic fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the pancreas and another organ or anatomic site.

MedDRA code (LLT): 10049192 · CTCAE v6.0 (NCI), original English text.

Pancreatic hemorrhage

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the pancreas.

MedDRA code (LLT): 10033626 · CTCAE v6.0 (NCI), original English text.

Pancreatic insufficiency

Gastrointestinal disordersNew in v6.0
  1. G1Asymptomatic and pancreatic enzymes <LLN
  2. G2Increase in stool frequency, bulk, or odor; steatorrhea
  3. G3Sequelae of absorption deficiency
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by impaired exocrine pancreatic function usually associated with decreased pancreatic exocrine enzymes production.

MedDRA code (LLT): 10033628 · CTCAE v6.0 (NCI), original English text.

Pancreatic necrosis

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Tube feeding or TPN indicated; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a necrotic process occurring in the pancreas.

MedDRA code (LLT): 10058096 · CTCAE v6.0 (NCI), original English text.

Pancreatitis

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Radiologic findings only
  3. G3Severe pain; vomiting; medical intervention indicated (e.g., analgesia, nutritional support)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation of the pancreas with no documented pancreas infection.

MedDRA code (LLT): 10033645 · CTCAE v6.0 (NCI), original English text.

Periodontal disease

Gastrointestinal disorders
  1. G1Gingival recession or gingivitis; limited bleeding on probing; mild local bone loss
  2. G2Moderate gingival recession or gingivitis; multiple sites of bleeding on probing; moderate bone loss
  3. G3Spontaneous bleeding; severe bone loss with or without tooth loss; osteonecrosis of maxilla or mandible
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder in the gingival tissue around the teeth.

MedDRA code (LLT): 10034536 · CTCAE v6.0 (NCI), original English text.

Peritoneal necrosis

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Tube feeding or TPN indicated; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a necrotic process occurring in the peritoneum.

MedDRA code (LLT): 10065704 · CTCAE v6.0 (NCI), original English text.

Proctitis

Gastrointestinal disorders
  1. G1Rectal discomfort, intervention not indicated
  2. G2Symptomatic (e.g., rectal discomfort, passing blood or mucus); fecal urgency or stool incontinence; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation of the rectum.

Navigational noteConsider Gastrointestinal disorders: Fecal incontinence.

MedDRA code (LLT): 10036774 · CTCAE v6.0 (NCI), original English text.

Rectal fissure

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic
  3. G3Invasive intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a tear in the lining of the rectum.

MedDRA code (LLT): 10064993 · CTCAE v6.0 (NCI), original English text.

Rectal fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the rectum and another organ or anatomic site.

MedDRA code (LLT): 10038062 · CTCAE v6.0 (NCI), original English text.

Rectal mucositis

Gastrointestinal disorders
  1. G1Asymptomatic or mild symptoms; intervention not indicated
  2. G2Moderate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by ulceration or inflammation of the mucous membrane of the rectum.

MedDRA code (LLT): 10063190 · CTCAE v6.0 (NCI), original English text.

Rectal necrosis

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Tube feeding or TPN indicated; invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a necrotic process occurring in the rectal wall.

MedDRA code (LLT): 10065709 · CTCAE v6.0 (NCI), original English text.

Rectal obstruction

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by blockage of the normal flow of the intestinal contents in the rectum.

MedDRA code (LLT): 10065707 · CTCAE v6.0 (NCI), original English text.

Rectal pain

Gastrointestinal disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the rectal region.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10038072 · CTCAE v6.0 (NCI), original English text.

Rectal perforation

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the rectal wall.

MedDRA code (LLT): 10038073 · CTCAE v6.0 (NCI), original English text.

Rectal stenosis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Severely altered GI function; tube feeding or hospitalization indicated; elective operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a narrowing of the lumen of the rectum.

MedDRA code (LLT): 10038079 · CTCAE v6.0 (NCI), original English text.

Rectal ulcer

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function (e.g., altered dietary habits, vomiting, diarrhea)
  3. G3Severely altered GI function; TPN indicated; elective invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the rectum.

MedDRA code (LLT): 10038080 · CTCAE v6.0 (NCI), original English text.

Retroperitoneal hemorrhage

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Self-limited; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the retroperitoneal area.

MedDRA code (LLT): 10038981 · CTCAE v6.0 (NCI), original English text.

Salivary duct inflammation

Gastrointestinal disorders
  1. G1Slightly thickened saliva; slightly altered taste (e.g., metallic)
  2. G2Thick, ropy, sticky saliva; markedly altered taste; alteration in diet indicated; secretion-induced symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Acute salivary gland necrosis; severe secretion-induced symptoms (e.g., thick saliva/oral secretions or gagging); tube feeding or TPN indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by inflammation of the salivary duct.

MedDRA code (LLT): 10056681 · CTCAE v6.0 (NCI), original English text.

Salivary gland fistula

Gastrointestinal disorders
  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between a salivary gland and another organ or anatomic site.

MedDRA code (LLT): 10039411 · CTCAE v6.0 (NCI), original English text.

Small intestinal mucositis

Gastrointestinal disorders
  1. G1Asymptomatic or mild symptoms; intervention not indicated
  2. G2Moderate symptoms; medical intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; interfering with oral intake; tube feeding, TPN or hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by ulceration or inflammation of the mucous membrane of the small intestine.

MedDRA code (LLT): 10065710 · CTCAE v6.0 (NCI), original English text.

Small intestinal obstruction

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Hospitalization indicated; invasive intervention indicated; limiting self care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by blockage of the normal flow of the intestinal contents of the small intestine.

MedDRA code (LLT): 10041101 · CTCAE v6.0 (NCI), original English text.

Small intestinal perforation

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the small intestine wall.

Navigational noteConsider Gastrointestinal disorders: Enterocolitis.

MedDRA code (LLT): 10041103 · CTCAE v6.0 (NCI), original English text.

Small intestinal stenosis

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function
  3. G3Symptomatic and severely altered GI function; tube feeding, TPN or hospitalization indicated; non-emergent operative intervention indicated
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a narrowing of the lumen of the small intestine.

MedDRA code (LLT): 10062263 · CTCAE v6.0 (NCI), original English text.

Small intestine ulcer

Gastrointestinal disorders
  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; altered GI function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a circumscribed, erosive lesion on the mucosal surface of the small intestine.

MedDRA code (LLT): 10041133 · CTCAE v6.0 (NCI), original English text.

Stomach pain

Gastrointestinal disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the stomach.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10042112 · CTCAE v6.0 (NCI), original English text.

Tooth development disorder

Gastrointestinal disorders
  1. G1Asymptomatic; hypoplasia of tooth or enamel
  2. G2Impairment correctable with oral surgery
  3. G3Maldevelopment with impairment not surgically correctable; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a pathological process of the teeth occurring during tooth development.

MedDRA code (LLT): 10044030 · CTCAE v6.0 (NCI), original English text.

Tooth discoloration

Gastrointestinal disorders
  1. G1Surface stains
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a change in tooth hue or tint.

MedDRA code (LLT): 10044031 · CTCAE v6.0 (NCI), original English text.

Toothache

Gastrointestinal disorders
  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the tooth.

MedDRA code (LLT): 10044055 · CTCAE v6.0 (NCI), original English text.

Typhlitis

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Not applicable
  3. G3Symptomatic (e.g., abdominal pain, fever, change in bowel habits with ileus); peritoneal signs
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by necrotizing enterocolitis in neutropenic patients. Also referred to as neutropenic enterocolitis, ileocecal syndrome, or cecitis.

Navigational noteIncludes Clostridioides difficile (c. diff, c. difficile). Also report Investigations: Neutrophil count decreased; Also consider Infections and infestations: Cecal infection.

MedDRA code (LLT): 10045271 · CTCAE v6.0 (NCI), original English text.

Upper gastrointestinal hemorrhage

Gastrointestinal disorders
  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the upper gastrointestinal tract (oral cavity, pharynx, esophagus, and stomach).

MedDRA code (LLT): 10055356 · CTCAE v6.0 (NCI), original English text.

Visceral arterial ischemia

Gastrointestinal disorders
  1. G1Not applicable
  2. G2Brief (<24 hrs) episode of ischemia managed medically and without permanent deficit
  3. G3Prolonged (>=24 hrs) or recurring symptoms and/or invasive intervention indicated
  4. G4Life-threatening consequences; evidence of end organ damage; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a decrease in blood supply due to narrowing or blockage of a visceral (mesenteric) artery.

MedDRA code (LLT): 10054692 · CTCAE v6.0 (NCI), original English text.

Vomiting

Gastrointestinal disorders
  1. G1Intervention not indicated
  2. G2Initiation of outpatient IV hydration; medical intervention indicated
  3. G3Initiation of tube feeding, or TPN; hospitalization indicated
  4. G4Life-threatening consequences
  5. G5Death
Definition and note

DefinitionA disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.

Navigational noteConsider Gastrointestinal disorders: Enterocolitis, Gastritis and/or Endocrine disorders: Adrenal insufficiency, Hypophysitis.

MedDRA code (LLT): 10047700 · CTCAE v6.0 (NCI), original English text.

From the same authorCódigo OncoCódigo Onco (in Portuguese): Brazilian public health system (SUS) codes for systemic cancer treatment.