Q6 – 9: Current Response

!Current Response
The current response section should be completed “at infusion” and at all post-infusion timepoints.

Question 6: Response for target lesion

The intent of this question is to determine the current response to infusion for the target lesion.

Indicate the current disease status for the target lesion, based on the RECIST criteria for target lesions. The current response should reflect the most recent response assessed during the reporting period.

• At infusion timepoint: Report the most recent evaluation prior to the start of the preparative regimen
• Post-infusion timepoints: Report the most recent evaluation closest to date of contact.

Select Not evaluable when no imaging / measurement is done at all at a particular timepoint, or a subset of lesion measurements are made at an assessment.

Question 7: Date of response for target lesion

Report the date when the current response for the target lesion occurred. This date should be the earliest date when all RECIST criteria for the response reported above were met. Report the date imaging (e.g. x-ray, CT, MRI).

If the exact date is not known, use the process for reporting partial or unknown dates as described in General Instructions, Guidelines for Completing Forms.

Question 8: Response for non-target lesion(s)

Indicate the current disease status for the non-target lesion, based on the RECIST criteria for non-target lesions. The current response should reflect the most recent response assessed during the reporting period.

• At infusion timepoint: Report the most recent evaluation prior to the start of the preparative regimen
• Post-infusion timepoints: Report the most recent evaluation closest to date of contact.

Select Not evaluable when no imaging / measurement is done at all at a particular timepoint, or a subset of lesion measurements are made at an assessment.

Select Not applicable if there are no non-target lesions.

Question 9: Date of response for non-target lesion(s)

Report the first date when the current response for the non-target lesion(s) occurred. This date should be the earliest date when all RECIST criteria for the response reported above were met. Report the date imaging (e.g. x-ray, CT, MRI).

If the exact date is not known, use the process for reporting partial or unknown dates as described in General Instructions, Guidelines for Completing Forms.

Section Updates:

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