Interim Analysis. An interim safety analysis will be performed after 5 patients have completed the Day 30 visit, on all data collected up to this timepoint.
Interim Analysis. (i) [**]
Interim Analysis. An interim analysis designed to evaluate effectiveness for continuing crossover of control arm study participants after the 1 year follow-up visit to EBV treatment will be performed when 74 (50% of the required minimum of 147) study participants have completed the 1 year follow-up. If crossover of control arm study participants is found to be justified by the interim analysis then crossover of a control arm study participant after (s)/he has reached the 1 year follow-up time point may be continued. The results of the interim analysis will be reviewed by the DSMB and FDA. If the DSMB recommends not continuing crossing control arm participants to EBV treatment then those control arm participants who have not crossed over will exit from the study per protocol after the 1-year visit.
Interim Analysis. During Phase 1, the SRT will review safety data after 3 DLT evaluable subjects have had the opportunity to be followed for 28 days after the KTE-X19 infusion. The SRT will review the safety data and make recommendations on further study conduct and progression of the study as outlined in Section 9.6. During Phase 2, the DSMB will review safety data after 20 Phase 2 subjects have been treated and followed for 30 days. The DSMB will also review SAEs on a monthly basis prior to the primary analysis. The DSMB may request additional safety data or modifying the study conduct. The sponsor may request additional reviews by the DSMB if safety concerns are identified. Data submitted to the DSMB may not have undergone completion of data cleaning procedures in order to facilitate timelines for DSMB review.
Interim Analysis. An interim Analysis will not be conducted for this study.
Interim Analysis. An interim analysis may be conducted once approximately half of the study subjects have completed the intended course of treatment to provide information for the planning of future clinical trials that may be designed or commenced prior to the completion of this trial. No changes will be made to the conduct of the present study, including premature termination or increased sample size, based on the results of this interim analysis and no adjustments to the significance level for the primary hypothesis will be made if this interim analysis is conducted. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Interim Analysis. An interim analysis may be conducted once approximately half of the study subjects have completed the intended course of treatment to provide information for the planning of future clinical trials that may be designed or commenced prior to the completion of this trial. No changes will be made to the conduct of the present study, including premature termination or increased sample size, based on the results of this interim analysis and no statistical adjustments for this interim analysis, if conducted.
Interim Analysis. An interim safety analysis will be performed in time to provide a safety update during the NDA process.
Interim Analysis. Following interim data readout at a predefined point set out in the Protocol, Company shall provide MSD with an electronic copy of the interim Study data when available, the criteria of which shall be determined by the JDC within [***] of the formation of the JDC (the “Interim Analysis”).
Interim Analysis. Interim analyses are planned during the study, primarily for summarizing and monitoring safety data, and will be conducted after 50 patients and after 250 patients are enrolled and have been treated on study for at least 4 months.
