RE: Connecting the dots5 Jun 2022 16:28
Hi SOG,
Thanks for the reply - yes, I knew the study was to assess the MTD however as the Adverse Events data indicates, there were some events noted.
As per the report, "An AE was defined as any untoward, undesired, or unplanned medical occurrence in a subject administered SRA737. All AEs and SAEs were assessed for seriousness, causality, and expectedness.
As specified in the Statistical Analysis Plan, the frequency of each AE was evaluated in the overall Safety Evaluable Population (all enrolled subjects who receive at least 1 dose of SRA737) of patients with advanced solid tumors, irrespective of tumor type. All AEs collected are included in the summary."
As I can't find the Statistical Analysis Plan and the above quote mentions assessing causality, I'm just wondering if 737 had not been administered, what are the odds that the events would have happened anyway?
Either way, it's all getting quite interesting the closer we get to CTAs and so on.