Q21-22: Disease Relapse or Progression

*This section is applicable to malignant diseases only and does not apply to commercially available products.

Question 21-22: Was a disease relapse or progression detected since the date of last report?

Disease relapse or progression can be documented by a variety of methods including molecular, flow cytometry, cytogenetic/fluorescent in situ hybridization (FISH), radiographic or hematological/clinical. Report Yes if disease relapse or progression was detected by any one of the methods in the current reporting period and report the first date (YYYY-MM-DD) of the relapse or progression detected.

If a disease relapse or progression was not detected in the current reporting period, report No and continue with question 23.

Section Updates:

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