As noted earlier, this means that patients with CR may not have a total sum of ‘zero’ on the case report form (CRF). Table 2.3.3-1: Best Overall Response (Confirmation of CR&PR Required) Overall Response First Time PointOverall Response Subsequent Time PointBEST Overall Response CR CR CR CR PR SD, PD OR PRa CR SDSD provided minimum criteria for SD duration met, otherwise, PD CR PDSD provided minimum criteria for SD duration met, otherwise, PD Revised Protocol No.: 04 Date: 31-May-2019 227 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS Table 2.3.3-1: Best Overall Response (Confirmation of CR&PR Required) Overall Response First Time PointOverall Response Subsequent Time PointBEST Overall Response CR NESD provided minimum criteria for SD duration met, otherwise, NE PR CR PR PR PR PR PR SD SD PR PDSD provided minimum criteria for SD duration met, otherwise, PD PR NESD provided minimum criteria for SD duration met, otherwise, NE NE NE NE CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease, and NE = inevaluable aIf a CR is truly met at first time point, then any disease seen at a subsequent time point, even disease meeting PR criteria relative to baseline, makes the disease PD at that point (since disease must have reappeared after CR). Best response would depend on whether minimum duration for SD was met. However, sometimes ‘CR’ may be claimed when subsequent scans suggest small lesions were likely still present and in fact the patient had PR, not CR at the first time point. Under these circumstances, the original CR should be changed to PR and the best response is PR. 2.3.4 Confirmation Scans Verification of Response: To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by consecutive or subsequent repeat assessments that should be performed no less than 28 days after the criteria for res ponse are first met. Subsequent documentation of a CR may provide confi rmation of a previously identified CR even with an intervening NE or PR (eg, CR NE CR or CR PR CR).