30 8.1.1. Modified RANO Criteria .................................................................................................... 30 8.2. Primary Efficacy Endpoints and Analyses ............................................................................ 31 8.2.1. Primary Analysis of Overall Survival at 12 Months (OS- 12) .................................................. 31 8.2.2. Sensitivity Analyses of OS- 12 ............................................................................................. 31 8.3. Secondary Efficacy Endpoint(s) and Analyses ....................................................................... 31 8.3.1. Objective Response Rate (ORR) .......................................................................................... 31 For Stage 2, an exact one-sample binomial test with a one-sided type I error rate of 2.5% will assess whether ORR is > 10%. An exact two-sided 90% CI will be computed for ORR usi ng the method of Clopper-Pearson (Clopper and Pearson 1934) .................................................................................... 32 8.3.2. Sensitivity Analyses of ORR ............................................................................................... 32 8.3.3. Duration of Response (DR) and Duration of Disease Control (DDC) ...................................... 32 8.3.4. Progression-Free Survival (PFS) .......................................................................................... 33 8.3.5. Progression-Free Survival at 6 and 12 Months (PFS-6 and PFS- 12) ........................................ 34 8.3.6. Overall Survival (OS) ......................................................................................................... 35 8.4. Exploratory Endpoints and Analyses .................................................................................... 35 8.4.1. Correlation between DR and DDC with OS .......................................................................... 35 9.