Look here. Primary and Secondary are all OS, with several OS stages. Guys, anyone who believes we failed Phase 3 is a moron. ITs working in current trials, no wonder they are redefining how to treat patients at various levels.
Primary Outcome Measures:
Incidence of adverse events assessed by National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
Will be compared between groups and to those reported for historical standards, including subjects treated with nivolumab in prior trials.
Overall Survival (OS) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
The overall survival curves will be displayed using a Kaplan-Meier curve for the pooled and individual treatments. A one-sample log-rank test will also be completed as a sensitivity analysis for the same survival rate assumption as the primary efficacy analysis, and a two-sample log-rank test will be used to compare the survival distribution between the two arms.
Secondary Outcome Measures:
Overall Survival rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
The overall survival curves will also be displayed using a Kaplan-Meier curve for the pooled and individual treatments. Estimated proportions of surviving subjects at 9 months will be provided along with the two-sided 95% CIs.
Overall Survival rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The overall survival curves will also be displayed using a Kaplan-Meier curve for the pooled and individual treatments. Estimated proportions of surviving subjects at 12 months will be provided along with the two-sided 95% CIs.
Overall Survival rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
The overall survival curves will also be displayed using a Kaplan-Meier curve for the pooled and individual treatments. Estimated proportions of surviving subjects at 18 months will be provided along with the two-sided 95% CIs.
Progression Free Survival (PFS) [ Time Frame: From treatment initiation to first progression or death assessed up to 12 months. ] [ Designated as safety issue: No ]
Kaplan Meier estimates will be provided along with the one-sided 95% lower bound on the survival rate. PFS survival will be compared between groups using a log-rank test.
Quality of Life (QoL) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Will be summarized descriptively for available subjects, and shifts from day 0 will be summarized for post-baseline assessments using the European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QoL) questionnaire.
Number of participants with complete response (CR) [ Time Frame: Up to 12 months of follow up after initiation of treatment ] [ Designated as safety issue: No ]
Rates of CR will be provided at fixed intervals where tumor size is evaluated. Exact two-sided CIs for the response rate will be provided and the denominator will include subjects with available information or who have previously died or progressed. A Fisher's exact test will be used to compare the test that the number of CR, CR+PR, and CR+PR+SD subjects is homogeneous across the treatment arms.
Number of participants with partial response (PR) [ Time Frame: Up to 12 months of follow up after initiation of treatment ] [ Designated as safety issue: No ]
Rates of PR will be provided at fixed intervals where tumor size is evaluated. Exact two-sided CIs for the response rate will be provided and the denominator will include subjects with available information or who have previously died or progressed. A Fisher's exact test will be used to compare the test that the number of CR, CR+PR, and CR+PR+SD subjects is homogeneous across the treatment arms.
Number of participants with stable disease (SD) [ Time Frame: Up to 12 months of follow up after initiation of treatment ] [ Designated as safety issue: No ]
Rates of SD will be provided at fixed intervals where tumor size is evaluated. Exact two-sided CIs for the response rate will be provided and the denominator will include subjects with available information or who have previously died or progressed. A Fisher's exact test will be used to compare the test that the number of CR, CR+PR, and CR+PR+SD subjects is homogeneous across the treatment arms.
Number of participants with progressive disease (PD) [ Time Frame: Up to 12 months of follow up after initiation of treatment ] [ Designated as safety issue: No ]
Rates of PD will be provided at fixed intervals where tumor size is evaluated. Exact two-sided CIs for the response rate will be provided and the denominator will include subjects with available information or who have previously died or progressed. A Fisher's exact test will be used to compare the test that the number of CR, CR+PR, and CR+PR+SD subjects is homogeneous across the treatment arms.
Objective response rate (ORR) defined as the percentage of participants with CR + PR [ Time Frame: Up to 12 months of follow up after initiation of treatment ] [ Designated as safety issue: No ]
Rates of ORR will be provided at fixed intervals where tumor size is evaluated.
Response/Stable Disease Rate (RSDR) defined as the percentage of participants demonstrating CR+PR+SD [ Time Frame: Up to 12 months of follow up after initiation of treatment ] [ Designated as safety issue: No ]
Rates of RSDR will be provided at fixed intervals where tumor size is evaluated.
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