Safety Variables. The safety variables include results of physical examinations, laboratory test results (clinical chemistry, hematology, urinalysis and microscopy), vital sign measurements, ECG results, weight, adverse events, and serious adverse events.
Safety Variables. Prior to treatment, the subject’s medical history will be reviewed, a urine pregnancy test will be performed (if applicable), and a physical examination will be conducted. During Ultherapy® treatment, the subject’s pain levels will be monitored using a validated Numeric Rating Scale (Attachment B). Pain scores should be obtained following each completed pass for each axilla treated. The average pain score for the entire axilla treated will then be recorded. At each subsequent visit, the subject will be queried about adverse events and changes in concomitant medications, and the treatment area will be visually examined. Additional pregnancy screening tests will be performed (if applicable) prior to treatment #2 and at the 90-day follow-up visit.
Safety Variables. Safety and tolerability will be assessed using reports of adverse events (including SAEs), deaths, xxxxx xxxxx (including blood pressure [BP], and pulse), cardiac monitoring (including 12-lead ECGs and LVEF (by MUGA or cardiac ECHO) , physical examination, lipids (Triglycerides, HDL, LDL and Cholesterol ), laboratory findings ( including Haematology, Clinical Chemistry and Urinalysis). These parameters will be collected for all patients. Adverse events will be collected throughout the study, from time of signature of informed consent until 28 days after the last dose of AZD5363/placebo. The detailed definitions and calculation of the safety and tolerability variables are given in section 6.4 and 11.2 of CSP. Appropriate summaries of these data will be presented as described in Section 4.2.4.
Safety Variables. The overall safety and tolerability of IPP-201101 treatment will be assessed throughout the study by evaluating adverse events and the following additional safety variables: • clinical laboratory (serum chemistry, hematology, and urinalysis) test results at each visit during the treatment period • xxxxx xxxxx (systolic and diastolic blood pressures, pulse, temperature, and body weight) measurements at each visit during the treatment period • 12-lead ECG findings at week 24 and the final assessment (or early termination) (week 52) • suicidality using the C-SSRS at each visit during the treatment period • adverse events that suggest an anaphylactic reaction to study drug during the treatment period • physical examination findings, including physical examination symptom directed findings, at selected time points throughout the study • concomitant medication usage throughout the study
