Patients with postoperative fistula
No history of gastrointestinal fistula or gastrointestinal perforation < 90 days of registration
History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula
History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula
Any history of gastrointestinal (GI) perforation, history of intra-abdominal abscess within 3 months prior to starting treatment, or history of abdominal fistula unless the fistula history meets all the following: (a) the fistula was surgically repaired, (b) there has been no evidence of fistula for at least 6 months prior to starting treatment, (c) patient is deemed to be at low risk of recurrent fistula, and (d) the case must be discussed with the study PI
Patients with clinically significant gastrointestinal abnormalities including, but not limited to:* Clinically significant signs and/or symptoms of bowel obstruction within 3 months prior to starting treatment* History of intra-abdominal abscess within 3 months prior to starting treatment* History of gastrointestinal (GI) perforation within 6 months prior to starting treatment* Evidence of abdominal fistula within 6 months prior to starting treatment; history of abdominal fistula will be considered eligible if the fistula was surgically repaired, and there has been no evidence of fistula for at least 6 months prior to starting treatment, and patient is deemed to be at low risk of recurrent fistula
Participants may not have had history of abdominal fistula or gastrointestinal perforation within the past 6 months