1/29/2024 0 Comments Keynote 426In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. The PFS rate was determined in all participants at Month 18. Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants Participants who did not experience PFS were censored at the last disease assessment. Death was always considered as confirmed PD. The date of PD was approximated by the date of the first assessment at which PD was documented per RECIST 1.1 by Blinded Independent Central Review (BICR). The appearance of one or more new lesions was also considered PD. The PFS rate was determined in all participants at Month 12. Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants The DOR for all participants who experienced a CR or PR is presented. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. PD was defined per RECIST 1.1 as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The percentage of participants who experienced a CR, PR, or SD is presented.ĭuration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging ReviewĭOR was defined as the time from first documented evidence of a Comple.ĭOR was defined as the time from first documented evidence of a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 until progressive disease (PD) or death due to any cause, whichever occurred first. poor) and geographic region (North America vs. The DCR was calculated using the Miettinen & Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. Through Database Cutoff Date of 2 (up to approximately 22 months)ĭisease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging ReviewĭCR was defined as the percentage of participants who had a Complete R.ĭCR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions), Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), or Stable Disease (SD) per RECIST 1.1 for ≥6 months. The percentage of participants who experienced a CR or PR is presented. The ORR was calculated using the Miettinen & Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. ORR was determined per RECIST 1.1 and was defined as the percentage of. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review
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