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Table 3 Impacts of non-malignant lesion selection within TL or NTL group according to the primary endpoint captured by the assessment

From: RECIST 1.1 and lesion selection: How to deal with ambiguity at baseline?

Baseline equivocal lesions pooled as

Remaining lesion

Response-Related Endpoint impact

Progression-Related Endpoint impact

TL

At least 1 other TL

With or without NTL

Prevents a CR

Limited impact on PR only if %NMTL < 20%

Delayed (or no) DOP

Limited impact only if %NMTL < 20% and no initial response

No other TL

No other NTL

Simulates a SD and prevents a CR*

No impact

No other TL

At least 1 NTL

Prevents a CR

No impact

NTL

With or without TL

Prevents a CR

No impact

  1. *The second reader would assess a baseline status of Non-Disease raising an eligibility issue if the measurability of the disease is an inclusion criterion