 If the start day is missing then the first day of the month will be used.  If the start day and month are missing then January 01 will be used.  If the start date is completely missing then the date of first dose will be used.  If the end date is complete and the imputed start date is after the end date, then the start date will be imputed as the end date. The summary of overall AEs (or SAEs) will be limited to TEAEs. All AEs will be coded using MedDRA version 17.0. An overall summary table of TEAEs will be provided with the following categories:  Number and percentage of patients with a TEAE  Number and percentage of patients with an SAE  Number and percentage of patients with a severe TEAE  Number and percentage of patients with a treatment-related TEAE  Number and percentage of patients with a TEAE leading to discontinuation of study treatment (ie, SL-701)  Number and percentage of patients with a treatment-related serious TEAE  Number and percentage of patients with a TEAE leading to death  Number and percentage of patients with a treatment-related TEAE leading to death 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 38 of 63 The TEAEs will be summarized by MedDRA system organ class (SOC) and preferred term (PT) by presenting the number and percentage of patients with each TEAE. The TEAE summary will be produced for the following categories:  TEAEs by SOC and PT  Serious TEAEs by SOC and PT  TEAEs leading to discontinuation of study drug (ie, SL-701) by SOC and PT  TEAEs leading to study withdrawal by SOC and PT  TEAEs by SOC, PT, and maximum severity  Treatment-related TEAEs by SOC and PT  Treatment-related serious TEAEs by SOC and PT  TEAEs leading to death by SOC and PT  Treatment-related TEAEs leading to death by SOC and PT The investigator’s reported severity of AEs using the National Cancer Institute- Common Terminology Criteria for Adverse Events (CTCAE) will also be reported . TEAE summ aries will be produced for the following categories:  TEAEs by SOC, PT, and maximum CTCAE Grade  TEAEs with CTCAE Grade ≥ 3 by SOC and PT  Treatment- related TEAEs with CTCAE Grade ≥ 3 by SOC and PT In the summaries, patients may be counted under multiple SOCs and PTs, but for each PT, p atient s are counted only once. If a patient has the same AE on multiple occasions, the highest severity recorded for the event will be presented and the highest drug relationship (defin ite, probable, possible, unlikely, unrelated), reclassified into related (possible, probable, definite) and not relate d (not related and unlikely), will be presented on the respective tables. Percentages are based on the number of patients in the ITT Population. Summaries presenting frequency of AEs by SOC and PT will be ordered by overall descending frequency of SOC and then, within a SOC, by overall descending frequency of PT. Listings will be provided for all AEs, AEs leading to discontinuation, and SAEs 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 39 of 63 9.4. REGIMEN LIMITING TOXICITIES Regimen limiting toxicity (RLT) includes any of the following events that occur anytim e through the first 12 doses of study treatment that are considered possibly, probably or definitely relat ed to investigational therapy:  Grade ≥ 3 b ronchospasm or Grade 2 bronchospasm that does not resolve within 24 hours despite appropriate medical treatment (e.g., inhaled albuterol);  Grade ≥ 3 generalized urticaria;  Other Grade ≥ 3 allergic reaction, such as exfoliative erythroderma, anaphylaxis, or vascular collapse;  Grade ≥ 3 non -hematologic toxicity (excluding hepatic laboratory toxicity) related to the study treatment regimen including Grade ≥ 3 injection site reaction due to SL -701 or immunoadjuvant administration, with the exception of transien t Grade ≥ 3 events as detailed below;  Intolerable Grade ≥ 3 skin (injection site) reaction lasting ≥ 7 days (at Grade ≥ 3) or that recurs despite discontinuation of imiquimod;  Grade ≥ 3 nausea/vomiting or diarrhea exceeding 24 h despite sufficient anti -emetic or anti-diarrheal activity, respectively;  Grade 3 or 4 neutropenia with fever;  Grade 4 hematologic toxicity (cytopenia) lasting ≥ 5 days  Cerebral edema associated with severe clinical manifestations (Grade 4), which in the investigator’s opinion is rel ated to study therapy. Cerebral edema (Grade 4) due to underlying tumor progression (based on imaging), change in concurrent medications (such as rapid decrease in corticosteroids), or a comorbid event (such as status epilepticus, severe electrolyte imbalance) as well as Grade < 4 cerebral edema will not be classified as RLT.