Statistical analysis
death
DISEASE PROGRESSION, DISEASE, EVALUABLE, ADVERSE EVENT
The Safety Evaluable population included all patients who received at least one dose of SRA737. The Response Evaluable population included patients who had measurable disease at baseline, received at least 75% of planned SRA737 doses in Cycle 1 and had at least one post-baseline disease assessment or discontinued treatment due to disease progression, adverse event, or death.Safety and response variables were summarized using descriptive statistics and PK parameters were determined using non-compartmental methods. A concentration-effect model was used to evaluate the relationship between plasma SRA737 concentrations and the mean change from baseline in QT interval corrected for heart rate using Fridericia’s formula (QTcF) in time-matched ECG measurements and PK samples collected on Day −7 to Day −4 and during Cycle 1.