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 safety@openbiome.org or call 617-575-2201, option 9. We are more than willing to discuss the specifics of your case in more detail. 

Name of Reporting Individual *
Name of Reporting Individual
Institutional Address *
Institutional Address
Phone *
Phone
Please provide a phone number where you can be easily reached by a member of the Clinical Assessment and Safety team to conduct an investigation of this adverse event.
Alternate Phone
Alternate Phone
Patient/Participant Information
Please do not use PHI (e.g., patient/participant's name, medical record number, social security number)
Sex *
Unit of weight:
Ethnicity
Race
Check any that apply.
Please list all comorbidities. If none, write n/a
Please list names of all medications. If none, write n/a
Please list all known drug allergies. If none, write n/a.
Clostridium difficile infection (CDI) History
Modified Horn Index Pre-FMT
Please select one
CDI Diagnosis
Check any that apply and describe below
Please scroll down to the bottom of the page for detailed descriptions of CDI severity.
Disease Type
Check all that apply
FMT History
Was an FMT performed?
FMT Procedure Date
FMT Procedure Date
Was the FMT performed under an IND?
Treating MD's Phone Number
Treating MD's Phone Number
(e.g., ID# XXXX-XXXX-XXXX)
(e.g., post-pylorus)
Any problems with the procedure or patient during FMT?
Was the patient discharged post-FMT?
Adverse Event Information
Date of Adverse Event
Date of Adverse Event
Please describe the clinical course and any new medical conditions, procedures, or medications for each event. Please include dates.
E.g. stool, urinalysis, pathology, autopsy, laboratory, diagnostic imaging, etc.
In your opinion, was the adverse event attributable to the FMT material? *
Was the adverse event unexpected? *
Was the adverse event serious? *
Please select one
Was the MedWatch 3500 Report sent to the FDA? *
If yes, what date was it sent?
If yes, what date was it sent?

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.