Report An Adverse Event

As part of our commitment to enable safe access to accountable, high-quality investigational FMT preparations and ensure compliance with FDA safety reporting regulations, all clinical partners and investigators that utilize investigational FMT material distributed by OpenBiome 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 has experienced a serious adverse event following their investigational FMT, please complete the following online AE report in its entirety. Upon submission, your report will go to the Patient Safety Team at OpenBiome and MMS, a contract research organization that provides support as our pharmacovigilance contractor. 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 * *

First

Last

Institution * *

Institutional Address * *

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

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

E-mail Address * *

Alternate Email

Occupation * *

Patient/Participant Information

Patient/Participant Identifier * *

Please do not use PHI (e.g., patient/participant's name, medical record number, social security number)

Age

Sex * *

Male
Female

Weight

Unit of weight:

Ethnicity

Hispanic/Latino
Not Hispanic/Latino

Pre-Existing Medical Conditions

Please list all comorbidities. If none, write n/a

List of Medications Prior to investigational FMT (including Anti-CDI medications)

Please list names of all medications. If none, write n/a

Drug Allergies

Please list all known drug allergies. If none, write n/a.

Clostridium difficile infection (CDI) History

Modified Horn Index Pre- investigational FMT

Please select one

1 - Mild (single, mild illness)
2 - Moderate (more severe, but uncomplicated disease)
3 - Severe (major illness, complications, or multiple conditions requiring treatment)
4 - Extremely severe (catastrophic illness that may lead to death)

Date of most recent CDI diagnosis and result (if available)

CDI Severity

Please scroll down to the bottom of the page for detailed descriptions of CDI severity.

Disease Type

Check all that apply

Recurrent (3 episodes of CDI and failure of 6-8 week standard of care antibiotics or >= 2 episodes of CDI resulting in hospitalization)
Refractory (Moderate CDI not responding to vancomycin for >= 1 week)
Fulminant (C. difficile colitis with significant systemic toxic effects and shock, resulting in need for colectomy, or death)
Other

Investigational FMT History

Was an investigational FMT performed?

Investigational FMT Procedure Date

Was the investigational FMT performed under an IND?

If yes, please provide the IND number and study name.

Treating MD (if different from individual completing this survey)

Treating MD's Phone Number

Treating MD's Email Address

FMP Unit ID Number

(e.g., ID# XXXX-XXXX-XX OR XXXXX-XX)

Route of investigational FMT Administration

If other, please describe here

Delivery Location (specific segment)

(e.g., post-pylorus)

Any problems with the procedure or patient during investigational FMT?

If yes, please describe:

Was the patient discharged post-investigational FMT?

If yes, please list discharge date, patient disposition at discharge, and location where discharged to

Adverse Event Information

Start Date of Adverse Event

End Date of Adverse Event

If ongoing, leave blank and check box below.

Ongoing

Ongoing

Please provide the adverse event terms * *

Please describe the adverse event in detail * *

Please describe the clinical course and any new medical conditions, procedures, or medications for each event. Please include dates.

Please list any pertinent tests, their dates, and their results.

E.g. stool, urinalysis, pathology, autopsy, laboratory, diagnostic imaging, etc.

Please describe the patient's current disposition: * *

In your opinion, was the adverse event attributable to the investigational FMT material? * *

Please explain the rationale for this opinion * *

Specify

*Specify sequelae, if applicable

Was the adverse event unexpected? * *

Was the adverse event serious? * *

Please select one

Not serious
Death (Please report if you suspect that the death was an outcome of the adverse event)
Life-threatening (Please report if you suspect that the patient was at substantial risk of dying at the time of the adverse event, or use or continued use of the device or other medical product might have resulted in the death of the patient)
Hospitalization, initial or prolonged (Please report if admission to the hospital or prolongation of hospitalization was a result of the adverse event)
Disability or Permanent Damage (Please report if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or quality of life)
Required Intervention to Prevent Permanent Impairment or Damage (Please report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product)
Congenital Anomaly/Birth Defect (Please report if you suspect that exposure to a medical product prior to conception or during pregnancy may have resulted in an adverse outcome in the child)
Adverse Event of Special Interest
Other Serious - Important Medical Events (Please report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes)

If you selected "Other Serious", please provide more details to describe why the event was considered serious.

Was the MedWatch 3500 Report sent to the FDA? * *

If yes, what date was it sent?