9.6. VITAL SIGNS Vital signs (blood pressures, heart rate, weight, BMI, respiratory rate, and temperature) will be monitored at every visit. Vital sign parameters and their changes from basel ine will be summarized descriptively by study visit using the Treated Population. Vital sign data will be listed for all patients by study visit. Temperature (in °C) = 5/9 (Temperature [in °F]-32). 9.7. ECG No ECG data will be collected in this trial. 9.8. PHYSICAL EXAMINATION A complete physical examination will be performed during the screening period and at the end of study treatment. The examination will include the following body systems: genera l appearance; eyes, ears, nose and throat; head and neck; chest and lungs; cardiovascular, abdomen, musculoskeletal; lymphatic; dermatologic; neurologic; psychiatric; and extremit ies. A directed physical exam involving any body systems for which abnormal findings were present d uring screening or prior examinations, and any systems determined relevant by the investig ator will be conducted every 4 weeks until the end of study treatment. Any clinically significant abnormalities at screening will be recor ded on the medical history form. Any new or worsening clinically significant abnormality at all other visits will be recorded as an AE. The physical examination data will be presented as a listing only. 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 42 of 63 10. INTERIM ANALYSES An Independent Data Monitoring Committee (IDMC) will evaluate all available safety data from the study. Details regarding the content and timing of the safety reviews are provided in the V ersion 1.0 of the IDMC charter dated 10-JUL-2014. 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 43 of 63 11.