Table 3.

Definitions of Cytomegalovirus Gastrointestinal Disease

Patient Category	Proven CMV Disease	Probable CMV Disease	Possible CMV Disease
Allogeneic HCT patients	Upper and/or lower GI symptoms plus macroscopic mucosal lesions plus CMV documented in tissuea	Upper and/or lower GI symptoms and CMV documented in tissuea (not by PCR) but without the requirement for macroscopic mucosal lesions	Upper and/or lower GI symptoms and CMV documented in tissue by PCR but without the requirement for macroscopic mucosal lesions;
Solid organ transplant patients except small bowel transplant patients	Upper and/or lower GI symptoms plus macroscopic mucosal lesions plus CMV documented in tissuea	Upper and/or lower GI symptoms and CMV documented in tissue (not by PCR) but without the requirement for macroscopic mucosal lesions	diarrhea rated at least National Cancer Institute, Common Terminology Criteria for Adverse Events (version 4.0), grade 2 and CMV documented in blood and exclusion of other likely causes of diarrhea
Small bowel transplant patients	Upper and/or lower GI symptoms plus macroscopic mucosal lesions plus CMV documented in tissuea	Not applicable
Autologous HCT and CAR T cell–treated patients	Upper and/or lower GI symptoms plus macroscopic mucosal lesions plus CMV documented in tissuea	Upper and/or lower GI symptoms and CMV documented in tissue (not by PCR) but without the requirement for macroscopic mucosal lesions

Abbreviations: CAR, Chimeric Antigen Receptor; CMV, cytomegalovirus; GI, gastrointestinal; HCT, hematopoietic cell transplant; PCR, polymerase chain reaction.

^aQuantitative PCR is not accepted as a diagnostic criterion for proven or probable CMV GI disease.