Adverse Event Reporting Online Form
As part of our commitment to enable safe, accountable, high-quality FMT treatments and ensure compliance with FDA safety reporting regulations, all clinical partners and investigators that utilize OpenBiome FMT material are required to report adverse events (AEs) to OpenBiome and possibly to the FDA.
If you suspect that one of your patients or study subjects experienced a serious adverse event following his or her FMT, please complete the following online AE report in its entirety. Upon submission, your report will be forwarded to the Pharmacovigilance and Safety Team at Finch Therapeutics, OpenBiome's licensed manufacturer of FMT material. We will then work with you to determine any actionable steps required.
If you have any additional questions, please also contact us at firstname.lastname@example.org or call 617-575-2201, option 9. We are more than willing to discuss the specifics of your case in more detail.
Thank you for taking the time to complete this form. Your information will be sent directly to the Pharmacovigilance and Safety Team. A representative from this team will contact you within 24 hours to follow up during weekdays, and within 24-48 hours during the weekend.
If your situation is urgent and you need to speak with a clinician immediately, please call (617) 575-2201, Option 9.
Definitions of CDI Disease Severity
Mild-Moderate: CDI with diarrhea but without additional symptoms or signs meeting the definition of severe or complicated CDI
Severe: CDI that presents with or develops during the course of the disease with hypoalbuminemia (serum albumin < 3 g/dl) and either of the following: (1) a white blood cell (WBC) count ≥ 15,000 cells/mm3 or (2) abdominal tenderness without criteria of complicated disease.
Severe-Complicated: is CDI that presents with or develops at least one of the following signs or symptoms: admission to intensive care unit, hypotension with or without required use of vasopressors, fever ≥38.5 ° C, ileus, or significant abdominal distention, mental status changes, WBC ≥35,000 cells/mm3 or < 2,000 cells /mm3, serum lactate levels >2.2 mmol/l, or any evidence of end organ failure.