Primary Efficacy Endpoint Sample Clauses

Primary Efficacy Endpoint. Review by a central radiologist, blinded to subject treatment assignments and independent from the clinical sites, will assess all tumor responses. The resulting response data will serve as primary clinical efficacy data for the trial. Deaths on study will also contribute to the PFS endpoint. PFS is defined as the duration of time from randomization to time of irPD or death, whichever comes first, or the last tumor assessment date for censored subjects. The primary efficacy endpoint, PFS, will be summarized and displayed by treatment group using ▇▇▇▇▇▇-▇▇▇▇▇ methods (SAS® PROC LIFETEST). Point estimates (25th, 50th, and 75th percentiles) will be provided, along with a 1-sided 90% confidence interval (CI). Treatments will be compared for the ITT population using a stratified log-rank test, with randomization stratification factors included, as the primary analysis. The HR between the 2 study arms, as well as the associated 90% CI, will be presented using ▇▇▇ proportional hazards regression (SAS® PROC PHREG) controlling for randomization stratification factors. ▇▇▇▇▇▇-▇▇▇▇▇ plots will be presented. The primary analysis will be a stratified log-rank test (using the randomization stratification factors) comparing PFS between the 2 randomized arms in the ITT population.

Primary Efficacy Endpoint. The mean change from baseline (Visit 2) in the Total CAPS-5 score after 12 weeks of treatment evaluated at Visit 6. Secondary Efficacy Endpoints: The first two secondary efficacy endpoints listed below are considered key secondary endpoints and will be tested in that order: • CGI-I score (analyzed as a continuous variable) after 12 weeks of treatment. • Change from baseline in the SDS total score after 12 weeks of treatment. A fixed sequence procedure will be applied to the key secondary efficacy endpoints to adjust for multiplicity and to control for overall type I error. Other Secondary Efficacy Endpoints: • Change from baseline in patients’ quality of sleep using the PROMIS Sleep Disturbance scale after 12 weeks of treatment. • Change from baseline in the disruption of work/school activities assessed using the SDS after 12 weeks of treatment. • Change from baseline in disruption of social life/ leisure activities assessed using the SDS after 12 weeks of treatment. • Change from Baseline in the disruption of family life/home responsibilities assessed using the SDS after 12 weeks of treatment. • Change from baseline in CAPS-5 Arousal and Reactivity (Criterion E) score after 12 weeks of treatment. • Change from baseline in CAPS-5 Intrusion symptoms (Criterion B) score after 12 weeks of treatment. • Change from baseline in CAPS-5 Persistent Avoidance (Criterion C) score after 12 weeks of treatment. • Change from baseline in CAPS-5 Negative Cognition and Mood (Criterion D) score after 12 weeks of treatment. • Change from baseline in CAPS-5 Sleep Disturbance (item E-6) score after 12 weeks of treatment. • Change from baseline in CAPS-5 Exaggerated Startle (item E-4) score after 12 weeks of treatment. • PGIC score after 12 weeks of treatment. • Proportion of patients with a PGIC score of “much improved” or “very much improved” after 12 weeks of treatment • Proportion of patients with a treatment response on the CGI-I defined as a CGI-I score of “much improved” or “very much improved” after 12 weeks of treatment. • Proportion of patients with a Total CAPS-5 score of 0 –10 (asymptomatic/few symptoms) after 12 weeks of treatment. • Proportion of patients with a Total CAPS-5 score of 0-22 (asymptomatic or mild PTSD/subthreshold) after 12 weeks of treatment. • Proportion of patients with Response, defined as a ≥ 10-point improvement from baseline in Total CAPS-5 score after 12 weeks of treatment. • Proportion of patients with Loss of Diagnosis, defined as Response ...

Primary Efficacy Endpoint. Change from baseline in six-minute-walk distance (6MWD) relative to placebo at Week 24

Primary Efficacy Endpoint. The primary endpoint of this study is all-cause mortality in the 3 years post-randomisation amongst all subjects randomised to treatment.