Q2 – 5: Best Response to Infusion

!Best Response to Infusion
The best response to infusion section can only be completed at the post-infusion timepoints. These questions will not enable for “at infusion” visit.

Question 2: Best response for target lesion

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

When evaluating the best response, determine the disease status within the reporting period using the RECIST criteria for target lesions. Compare this response to all previous post-infusion reporting periods. If the response in the current reporting period is the best response to date, report the disease status established within this reporting period.

Select Previously reported when the best response to infusion was established in a previous reporting period.

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 3: Date of best response for target lesion

Report the first date when the best 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 of 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 4: Best response for non-target lesion(s)

The intent of this question is to determine the best overall response to infusion for the non-target lesion(s).

When evaluating the best response, determine the disease status within the reporting period using the RECIST criteria for non-target lesions. Compare this response to all previous post-infusion reporting periods. If the response in the current reporting period is the best response to date, report the disease status established within this reporting period.

Select Previously reported when the best response to infusion was established in a previous reporting period.

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 5: Date of best response for non-target lesion(s):

Report the first date when the best 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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