Intractable diarrhea or severe malabsorption. Inability to tolerate oral medication. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements or study scheduled visits. Physician's decision including, but not limited to, major toxicity, adverse events, noncompliance, and any other serious and unexpected or life-threatening toxicity. Patients are followed until the conclusion of the pregnancy.
Patient requires disallowed medications.
Patients who discontinue due to an adverse event should be followed until resolution or 30 days after completing the study. Always watch for outdated information. This information is designed to support, not replace, the relationship that exists between you and your doctor.