The following types of patients will not count as a progression event in this trial:
A Treatment discontinuation for undocumented progression, B Treatment discontinuation for toxicity or other reason, C New anticancer treatment started prior to documented progression, D Progression after more than one missed visit, E Death after more than two missed visits.
1. Where did you come up with the above list? 2. If this is indeed the case, then this could in part explain the approx 14% of trial participants (46 patients) who never received the DCVax-L vaccine (only the placebo), correct? Because a progression event (PFS event) is a requirement for a patient to move from placebo arm to treatment arm & thus a requirement to start receiving the real vaccine.