Interim Analysis Clause Samples

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. 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. (i) [**] (ii) [**] [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. (iii) [**] (A) [**] (B) [**] (iv) [**] [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.

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.

Interim Analysis. An interim Analysis will not be conducted for this study.

Interim Analysis. Subjects with renal impairment assessed as severe, along with matched-control healthy subjects, will begin enrolling in the study first. Continuous review of the safety data and PK data (if available) from up to 8 subjects with severe renal impairment and up to 8 matched-control healthy subjects with normal renal function will be conducted after these subjects have completed all study-related assessments through 72 hours (approximately 3 half-lives) postdose, at a minimum. The safety data will include AEs and SAEs, vital signs, physical examinations, ECGs, and clinical laboratory evaluations. If a clinically relevant difference is observed in the PK of subject(s) with severe renal impairment compared to matched-control healthy subjects during continuous review of the safety and PK data, then subjects with renal impairment assessed as mild (60 ≤ eGFR < 90 mL/min/1.73 m2) and/or moderate (30 ≤ eGFR < 60 mL/min/1.73 m2), along with additional matched-control healthy subjects (if needed) will be enrolled, to determine the extent of the effect of varying severities of renal impairment on the PK of LOXO-305. Enrollment of subjects with mild and/or moderate renal impairment will only be initiated if deemed necessary by the Sponsor following the continuous review of safety and PK data from severe renal impairment subjects and their matched-control healthy subjects. If no clinically relevant effect on PK is observed, enrollment of mild and/or moderate subjects will not occur. Enrollment and dosing for remaining subjects in Group 2 and/or Group 3 may only occur after the data for Group 1 and Group 4 are reviewed and the Covance Medical Monitor, Investigator (or designee), and Sponsor agree it is safe to proceed with dosing. Subjects will be recruited for Group 2 and/or Group 3 so that up to 8 subjects with mild renal impairment, up to 8 subjects with moderate renal impairment, and up to an additional 16 matched-control healthy subjects with normal renal function may be enrolled, with the goal of having at least 6 subjects with mild renal impairment and at least 6 subjects with moderate renal impairment and their matched-control healthy subjects complete the study. Teleconferences will occur as needed between the Covance Medical Monitor, Investigator (or designee), and Sponsor to discuss PK, safety, and tolerability data.

Interim Analysis. Not applicable

Interim Analysis. Two IAs will be conducted during the study. The first interim analysis is futility only and will be conducted when at least 110 PFS events have occurred. The study may stop for futility if the observed PFS HR is > 1. This IA applies to PFS only. The second IA will be conducted at the final analysis of PFS when at least 330 PFS events have occurred. This IA applies to OS only and will be the first interim look of OS. A Lan-DeMets alpha-spending function using an ▇’▇▇▇▇▇-▇▇▇▇▇▇▇ stopping boundary is used to control overall type I error for OS at 2-sided alpha level of 0.05. It is projected that approximately 200 deaths will have occurred at this IA. The final analysis of OS will be conducted when at least 300 deaths have occurred. It is projected that the final analysis for OS will be approximately 1 year after the final analysis of PFS. If the primary endpoint of PFS is statistically significant and preliminary data suggest that 300 deaths will not occur within 1 year after the final analysis of PFS, another IA of OS may be conducted 1 year after the final analysis of PFS and the stopping boundary will be adjusted according to the prespecified alpha-spending method.

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.