8.3.1. Objective Response Rate (ORR) ORR is the percentage of patients who have at least one overall tumor response of complete response (CR) or partial response (PR) documented on 2 consecutive MRIs ≥ 4 weeks apart by modified RANO criteria (Wen 2010, Appendix 2). Only response data that are obtained before disease progression will be included in ORR. In the absence of disease progression, response data DocuSign Envelope ID: B3F56764-C440-4885-BA44-7578C4A73DB3 Stemline Therapeutics, Inc. Protocol: STML- 701-0114 Version 3.0, 10-JUL-2015 (Amendment 2) Statistical Analysis Plan Page 32 of 63 for all evaluable assessments will be included in the assessment of ORR. These assessments will be included whether or not the patient has discontinued treatment or has received another therapy prior to disease progression. Should a patient have no evaluable post-treatment tumor response data, the patient will be counted as a non-responder. Analyses of ORR will use the mITT, ITT and PP Populations. For Stage 1, 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 using the method of Clopper-Pearson (Clopper and Pearson 1934). 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 using the method of Clopper-Pearson (Clopper and Pearson 1934) 8.3.2. Sensitivity Analyses of ORR A sensitivity analysis will estimate ORR using the mITT, ITT and PP Popu lations as in the primary endpoint analysis but will use RECIST (version 1.1) rather than the modified RANO criteria in assessing tumor response. The analysis will be based on the investigator’s overal l assessments according to RECIST (version 1.1) An exact two-sided 90% CI will be computed for ORR using the method of Clopper-Pearson (Clopper and Pearson 1934 8.3.3. Duration of Response (DR) and Duration of Disease Control (DDC) Duration of response (DR) is defined as the time from the date measurement criteria are first m et for objective response (i.e., either CR or PR) until the first date that the criter ia for PD is met, or death due to any cause, whichever occurs first. The end of response should coincide with the date of progression or death from any cause used for the progression-free survival (PFS) endpoint (see Section 8.3.2). If a patient does not progre ss or die after a response of CR or PR, then the patient’s DR will be censored at the date of the patient’s last tumor assessment (i.e., the PFS censoring time). Only patients in the mITT, ITT and PP Populations who attain a confirmed response of either CR or PR will be included in the estimation of DR. DR will be calculated as follows: Duration of response (months) = ((Date of Progression/Death/Censoring) – Date of first recorded CR or PR) + 1)/30.4375. Duration of disease control (DDC) is defined as the time from the date measurement criteria are first met for CR, PR or SD until the first date that the criteria for PD is met, or death due to any cause, whichever occurs first. DocuSign Envelope ID: B3F56764-C440-4885-BA44-7578C4A73DB3 Stemline Therapeutics, Inc. Protocol: STML- 701-0114 Version 3.0, 10-JUL-2015 (Amendment 2) Statistical Analysis Plan Page 33 of 63 The end of disease control should coincide with the date of progression or death from any cause used for the progression-free survival (PFS) endpoint (see Section 8.3.2). If a patient does not progress or die after a response of CR, PR or SD , then the patient’s D DC will be censored at the date of the patient’s last tumor assessment (i .e., the PFS censoring time). Only patients in the mITT, ITT and PP Populations who attain a confirmed response of either CR or PR will be included in the estimation of DR DDC will be calculated as follows: Duration of Disease Control (months) = ((Date of Progression/Death/Censoring) – Date of first recorded CR, PR or SD) + 1)/30.4375. For both Stages 1 and 2, the median DR and DDC will be estimated using a Kaplan-Meier survival analysis using the mITT and ITT Populations. The distribution of DR and DDC times will be displayed by presenting the estimated survival distribution function as a function of time. T he median DR and DDC with their associated two-sided 90% CI (Brookmeyer and Crowley, 1982) will be provided. A sensitivity analysis will estimate DR and DDC in both Stages 1 and 2 in the mITT,ITT and PP Population as described above but will use RECIST (version 1.1) rather than the modif ied RANO criteria for assessing tumor response. Only the investigator’s overall objective tumor response as judged by RECIST will be reported; separate analyses will not be provided for tar get and non- target lesions.