In this circumstance, the best overall response can be interpreted as in Table 2.3.3-1. When SD is believed to be best response, it must meet the protocol specified minimum time from the d ate of first treatment or rando mization date. For example, if the first scheduled follow-up imaging visit is Week 6 ( ±7 days) for a particular protocol, a Best Response of SD can only be made af ter the subject is on-study for a minimum of 6 weeks (42 days) minus 7 days, for an absolute minimum time on-study of 35 days from the reference start date (reference date is considered Day 1 on study). If the subject is not on-study for at least this am ount of t ime, any tumor assessment indicating stable disease before this time period will have a Best Response of NE unless PD is identified. Special note on response assessment: When nodal disease is included in the sum of target lesions and the nodes decrease to ‘normal’ s ize (< 10 mm), they may st ill have a measurement reported on scans. This measurement should be recorded even though the nodes are normal in order not to overstate progression should it be based on increas e in size of the nodes.