Adverse Events Reporting

Reportable Adverse Events & Reporting Period

Adverse Events will be collected from initiation of conditioning through the D365 timepoint (end of study). If a patient goes off-study or off-protocol prior to D365, only serious adverse events will be collected for a 30-day safety follow-up period, unless the end of study comes first. Adverse events should be followed to resolution, death, or until the site Principal Investigator (PI) concludes that the event is stable with no further improvement anticipated. Adverse events will be reported on the Adverse Events CRF, per protocol.

Medical conditions present at screening (i.e., before initiation of conditioning) are not considered AEs. These medical conditions should be adequately documented as medical history. However, medical conditions present at baseline that worsen in intensity or frequency during the treatment or post-treatment periods should be recorded as AEs in the study EDC if they meet the study reporting requirements defined below.

For the purposes of this study, the following events are not considered AEs because they are expected to occur in conjunction with transplant procedures/post-procedure time frame, or are associated with study endpoints, disease processes and/or standard care of this population:

• Events that should NOT be recorded as an AE or SAE as they will be collected on the event specific form for study endpoint monitoring:
  • Disease progression
  • Disease relapse
  • Primary or secondary graft failure
  • Acute and/or chronic GVHD
• Events that should NOT be recorded as an AE unless they result in a SERIOUS outcome:
  • Cytokine release syndrome
  • Infections
  • Hematological toxicities (e.g., anemia, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, white blood cell decreased)
  • Early post-operative pain and/or post-anesthesia/conscious sedation emesis, nausea, or headache (within 24 hours post-index procedure).
  • Chest pain without associated electrocardiogram (ECG) changes.

In the event additional information is required for the Medical Monitor to complete their assessment, the CIBMTR safety team may reach out for redacted source documentation. Please send redacted source documentation via secure email to the CIBMTR safety team member for further review.

GVHD and Primary Graft Failure

GVHD and primary graft failure are reported on event-specific CRFs, which collect data specific to these events. These events should not be reported on the Adverse Events CRF. Refer to the GVHD and PGF sections of the CCGs for reporting instructions.

If it is determined that a reported event does not meet protocol-defined reporting requirements:

Please reset the CRF in Veeva using guidance below.

• Click into the CRF
• Click “Edit Form”
• Once the form is editable, click the ellipses at the right-hand corner
• Choose “Reset Form” from the drop down
• A warning message will appear to confirm “reset”
• Once confirmed, the form will be “reset” and all fields will be blank. Please do not re-save the CRF once it is blank.
  

CCG v1.0 | CRF v1.3

Copyright © 2004-2025 The Medical College of Wisconsin, Inc. and NMDP. All Rights Reserved.
CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.