Q22-25: Autoimmune Disorder

Question 22: Was a subsequent autoimmune disorder diagnosed?

Indicate if the recipient developed a new autoimmune disorder in the current reporting period (post-infusion). Do not report any autoimmune disorders that were diagnosed pre-infusion and persisted post-infusion.

*Reporting multiple autoimmune disorders
If more than one autoimmune disorder occurred in the reporting period, complete the autoimmune disorder questions for each event by adding an additional instance in the FormsNet3^SM application.

Questions 23 – 24: Specify the autoimmune disorder

Indicate which autoimmune disorder was diagnosed in this reporting period.

• Autoimmune cytopenias: examples include immune-mediated thrombocytopenia, autoimmune hemolytic anemia, autoimmune neutropenia)
• Colitis: inflammation of the colon
• Hepatitis: inflammation of the liver
• Nephritis: inflammation of the
• Pneumonitis: inflammation focally or diffusely affecting the lung parenchyma
• Thyroiditis: inflammation or destruction of the thyroid gland

If the autoimmune disorder is not listed as an option, select Other autoimmune disorder and specify.

Source: Common Terminology Criteria for Adverse Events (CTCAE) v6.0

Question 25: Date of diagnosis

Report the diagnosis date of the new autoimmune disorder, using the clinical or histologic diagnosis date.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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