Table 1 Clinically significant upper- and lower-GI events (CSULGIEs) composite end point

GD hemorrhage

Acute hemorrhage of unknown origin, including presumed small bowel hemorrhage

Gastric-outlet obstruction

Clinically significant anemia of presumed occult GI origin, including possible small bowel blood loss

GD, small-bowel, or large-bowel perforation

Large-bowel hemorrhage

Small-bowel hemorrhage

Small-bowel obstruction

Clinically significant anemia of defined GI origin

Symptomatic ulcers