Table 3.

CSULGIE composite endpoint.

With Lesion	Without Lesion
GD hemorrhage Endoscopic evidence of GD ulceration or erosion or other likely causative lesion, and clinical evidence of recent hemorrhage Gastric outlet obstruction Clinical, surgical, endoscopic, or radiographic evidence with symptoms consistent with obstruction GD, small bowel, or large bowel perforation Clinical, surgical, or radiographic confirmation associated with symptoms consistent with perforation Large bowel hemorrhage Frank melena or PR blood loss with no evidence of source on EGD and likely causative lesion on colonoscopy. Hemorrhoidal hemorrhage is included if associated with a clinically significant drop in Hct ≥ 10% points and/or Hgb ≥ 2 g/dl from baseline Small bowel hemorrhage Frank melena or PR blood loss with likely causative lesion on small bowel investigation Small bowel obstruction* Nausea and vomiting ≥ 24 h with evidence of narrowing occurring in the duodenum, jejunum, or ileum (confirmed by endoscopy, radiography, or surgery). Obstruction caused by sources in the lower GI tract such as colon cancer, diverticulitis, or adhesions from prior surgery not included Clinically significant anemia of defined GI origin No clinical evidence of acute GI hemorrhage but with fall in Hct ≥ 10% points and/or Hgb ≥ 2 g/dl from baseline, with likely causative lesion on colonoscopy or EGD (or small bowel investigation) with no non-GI source of anemia, and in RA patients, disease activity should be stable Symptomatic ulcers† Cases that do not meet the definition of an ulcer complication but do have endoscopic evidence of a gastric and/or duodenal ulcer, as adjudicated by the GI events committee	Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage Frank hematemesis, melena, or PR blood loss, with no evidence of likely causative lesion on EGD or colonoscopy (or small bowel investigation) Clinically significant anemia of presumed occult GI origin, including possible small bowel blood loss No overt clinical evidence of acute GI hemorrhage but with fall in Hct ≥ 10% points and/or Hgb ≥ 2 g/dl from baseline, with no evidence of likely causative lesion on EGD or colonoscopy (or small bowel investigation) with: no non-GI source of anemia identified, and in RA patients, disease activity should by stable

With Lesion

Without Lesion

GD hemorrhage

Endoscopic evidence of GD ulceration or erosion or other likely causative lesion, and clinical evidence of recent hemorrhage

Gastric outlet obstruction

Clinical, surgical, endoscopic, or radiographic evidence with symptoms consistent with obstruction

GD, small bowel, or large bowel perforation

Clinical, surgical, or radiographic confirmation associated with symptoms consistent with perforation

Large bowel hemorrhage

Frank melena or PR blood loss with no evidence of source on EGD and likely causative lesion on colonoscopy. Hemorrhoidal hemorrhage is included if associated with a clinically significant drop in Hct ≥ 10% points and/or Hgb ≥ 2 g/dl from baseline

Small bowel hemorrhage

Frank melena or PR blood loss with likely causative lesion on small bowel investigation

Small bowel obstruction*

Nausea and vomiting ≥ 24 h with evidence of narrowing occurring in the duodenum, jejunum, or ileum (confirmed by endoscopy, radiography, or surgery). Obstruction caused by sources in the lower GI tract such as colon cancer, diverticulitis, or adhesions from prior surgery not included

Clinically significant anemia of defined GI origin

No clinical evidence of acute GI hemorrhage but with fall in Hct ≥ 10% points and/or Hgb ≥ 2 g/dl from baseline, with likely causative lesion on colonoscopy or EGD (or small bowel investigation) with
- no non-GI source of anemia, and
- in RA patients, disease activity should be stable

Symptomatic ulcers†

Cases that do not meet the definition of an ulcer complication but do have endoscopic evidence of a gastric and/or duodenal ulcer, as adjudicated by the GI events committee

Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage

Frank hematemesis, melena, or PR blood loss, with no evidence of likely causative lesion on EGD or colonoscopy (or small bowel investigation)

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

No overt clinical evidence of acute GI hemorrhage but with fall in Hct ≥ 10% points and/or Hgb ≥ 2 g/dl from baseline, with no evidence of likely causative lesion on EGD or colonoscopy (or small bowel investigation) with:
- no non-GI source of anemia identified, and
- in RA patients, disease activity should by stable

↵* Primary endpoint in GI-REASONS only;
↵† primary endpoint in GI-REASONS and a secondary endpoint in CONDOR. CSULGIE: clinically significant upper and lower gastrointestinal events; GD: gastroduodenal; GI: gastrointestinal; PR: post-rectal; EGD: esophagogastroduodenoscopy; Hgb: hemoglobin; Hct; hematocrit; RA: rheumatoid arthritis.