AEs, n (%)b | Patients with Blood Loss (n=932) | Patients without Blood Loss (n=50,116) |
---|---|---|
Any AE | 612 (66) | 29,222 (58) |
GI-Related AEs | ||
Gastric ulcer | 14 (1.5) | 101 (0.2) |
GI hemorrhage | 7 (0.8) | 33 (< 0.1) |
Esophageal ulcer | 5 (0.5) | 24 (< 0.1) |
Melena | 12 (1.3) | 57 (0.1) |
Potential GI-Related AEs | ||
Anemia | 82 (8.8) | 317 (0.6) |
Increase in blood creatinine | 16 (1.7) | 207 (0.4) |
Decrease in hemoglobin | 83 (8.9) | 120 (0.2) |
Decrease in hematocrit | 97 (10.4) | 228 (0.5) |
Decrease in red blood cell count | 7 (0.8) | 23 (< 0.1) |
Hematochezia | 9 (1.0) | 126 (0.3) |
Non-GI-Related AEs | ||
Coronary artery disease | 11 (1.2) | 144 (0.3) |
Myocardial infarction | 6 (0.6) | 99 (0.2) |
Pneumonia | 16 (1.7) | 202 (0.4) |