Safety Parameters. 11.1.1. Demographic Demographic details will be collected at Screening only.
Safety Parameters. Safety parameters for this study are described in the master protocol. In addition, urine dipstick or urine analysis for protein determination will be performed at Screening and prior to each bevacizumab administration. Patients discovered to have ≥2 proteinuria on dipstick should not be administered bevacizumab, should undergo a 24-hour urine collection, and must demonstrate <2 g of protein in 24 hours to be eligible for bevacizumab treatment to resume.
Safety Parameters. The safety assessments will include adverse events (AEs), BCVA, slit-lamp exam and biomicroscopy, indirect ophthalmoscopy, intraocular pressure (TOP), serum chemistry, hematology, xxxxx xxxxx, physical exam, fundus photography, fluorescein angiography, EKG, pregnancy.
Safety Parameters. The primary safety parameters are the occurrence and severity of adverse events throughout the study treatment period. Refer to §8.2 for AE reporting requirements. The pre-dose assessments performed on Day 1—including PE, xxxxx xxxxx, and laboratory assessments—will serve as the baseline and the standard for comparison of all follow-up examinations. All abnormal findings will be noted on follow-up and compared to baseline and clinically significant changes will be noted as adverse events.
Safety Parameters. All assessments will be conducted according to the Schedule of Assessments (Table 2).
Safety Parameters. To avoid inter-observer variability, every effort should be made to ensure that the same individual who made the initial baseline determinations completes all safety assessments. Safety parameters include vital sign measurements, ECG results, physical examination results, adverse events, serious adverse events, weight, and laboratory test results (clinical chemistry, hematology, urinalysis and microscopy).
Safety Parameters
