No ENI (109) | ENI (103) | |||
---|---|---|---|---|
Grade 2 GI events | Diarrhea | Endoscopic evidence of proctitis | 1 (1%) | 0 |
Endoscopy not performed | 1 (1%) | 1 (1%) | ||
Endoscopic evidence of proctitis | 1 (1%) | 4 (4%) | ||
Grade 3 GI events | Rectal bleeding | Required endoscopic laser coagulation procedure | 1 (1%) | 1 (1%) |
Required blood transfusion | 0 | 1 (1%) | ||
Grade 3 GU events | Urethral stricture requiring dilation | 3 (3%) | 4 (4%) | |
Gross hematuria | 4 (4%) | 5 (5%) | ||
Chronic cystitis requiring long-term catheterization | 1 (1%) | 0 |