Which parameters are past a protocol threshold right now?
Four. Neutrophils below 1.0 in two participants · one temperature at 38.4 °C · one ALT at the increased-monitoring level · one creatinine awaiting its 48-hour repeat.
Appendix 5 · §8.1.5Any incomplete pairs?
One. The temperature crossing has no neutrophil count inside seven days. Febrile neutropenia needs both limbs.
Appendix 5What does the protocol require for that ALT?
Participants meeting increased-monitoring criteria but not stopping criteria may continue with weekly liver chemistry. Stopping criteria require discontinuation and a sponsor report within 24 hours.
§8.1.5 · thresholds are in Figure 1, quoted in full on tapWhich arm has worse neutropenia?
I can't break parameters down by arm where the split would read as an outcome comparison. I can show each participant's own value, and the cohort spread.
Synopsis · co-primary endpoints
Dose and stopping rules are quoted, never paraphrased. Safety parameters are not broken down by arm, for the same reason the endpoint figures stay pooled.