![]() Treated joint bleeds: treated bleeds where bleed type was "joint bleed" accompanied by at least one of following symptoms: "increased swelling or warmth of the skin over the joint", "increasing pain" or "decreased range of motion or difficulty using the joint compared with baseline". All bleeds: included both treated and non-treated bleeds. Treated bleeds: bleeds followed by a hemophilia medication reported to be a "Treatment for bleed". The number of bleeds over the efficacy period was analyzed as an ABR using a negative binomial regression model. Change From Baseline in Body Temperature at Specified Timepoints.Abs = absolute count SGOT/AST = aspartate aminotransferase SGPT/ALT = alanine aminotransferase Baseline was defined as the last available assessment prior to first receipt of study drug. A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms resulted in a change in study treatment resulted in a medical intervention or a change in concomitant therapy or was clinically significant in the investigator's judgment. Not every laboratory abnormality qualified as an adverse event (AE). The World Health Organization (WHO) toxicity grading scale was used for determining the severity of laboratory abnormalities (i.e., test results outside of the reference range) for hematology and biochemistry parameters Grade 0 is normal and Grades 1 to 4 represent worsening levels of the parameter outside of the normal range in the specified direction of the abnormality (high and low are above and below the range, respectively). Number of Participants by Hematology and Biochemistry Laboratory Parameter Test Results as Shifts From the WHO Toxicity Grade at Baseline to the Worst WHO Toxicity Grade Post-Baseline. ![]() Total patient-years at risk is the sum over all patients of the time intervals (in years) between start of study therapy (study day 1) and the end of follow up. The AE rate per 100 patient-years was computed as follows: AE Rate = (Number of AEs observed/ Total patient-years at risk)*100. The terms "severe" and "serious" are not synonymous severity and seriousness were independently assessed for each AE. Regardless of severity, some AEs may have also met seriousness criteria. The WHO toxicity grading scale was used for assessing AE severity (i.e., intensity of an AE) any AEs not specifically listed in the WHO toxicity grading scale were assessed for severity according to the following grades: Grade 1 is mild Grade 2 is moderate, Grade 3 is severe Grade 4 is life-threatening and Grade 5 is death. Investigators sought information on adverse events (AEs) at each contact with participants. Why Should I Register and Submit Results?.
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