statistical analysis plan


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statistical analysis plan

A document containing a detailed elaboration of the principal features of the analysis described in a clinical trial protocol, and which includes procedures for statistical analysis of the primary and secondary variables and other data.
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According to the statistical analysis plan, analyses were also conducted to assess the activity of FOLOTYN and erlotinib in predefined patient cohorts, which included light smokers (n=37) and heavy smokers (n=164), current smokers (n=50) and former smokers (n=151), squamous (n=76) and non-squamous histology (n=107), and patients who received prior pemetrexed (n=30) and those who had not (n=171).
As specified in the statistical analysis plans that were submitted to the FDA for both Phase III studies, a p-value of 0.
According to the statistical analysis plan, analyses were conducted to assess the activity of FOLOTYN and erlotinib in predefined patient cohorts, which included light smokers (n=37) and heavy smokers (n=164), current smokers (n=50) and former smokers (n=151), squamous (n=76) and non-squamous histology (n=107), and patients who received prior pemetrexed (n=30) and those who had not (n=171).
The statistical analysis plan for AGENDA prospectively specified a "pooled analysis" that combined final results for overall survival from both studies.
While additional work remains to achieve final agreement on the specifics of the clinical protocol and statistical analysis plan, we believe we now have sufficient information to provide a scope for the trial.
The organization has participated in more than 100 clinical trials, offering clients consulting services that include R&D expertise, statistical analysis plan development, project and data management, quality enforcement and team building.
According to the trial's Statistical Analysis Plan (SAP), a total of 725 events were required to detect a 25% improvement (12.
The 725th event triggers the steps towards the pre-specified analysis according to the trial's Statistical Analysis Plan (SAP).
Food and Drug Administration (FDA)-reviewed, pre-specified statistical analysis plan, the primary endpoint of mortality was reduced in all BEST trial patients on Gencaro by 13 percent (hazard ratio (HR) 0.
Additionally, an independent party will be appointed by CBI for access to relevant non-privileged documentary materials including, the statistical analysis plans, the study dataset after unblinding, any correspondence with the US FDA and other medical/clinical regulatory entities, assess for CBI's benefit, the ongoing conduct of the DIA-AID 2 study, the conduct of the completed DIA-AID 1 study, the integrity of the studies' readouts and any potential regulatory path forward for DiaPep277.
o Medical review and input of protocol design and feasibility, statistical analysis plans, investigator brochure, case report form and informed consents

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