English to Russian Medical Medical: Pharmaceuticals

Unscheduled visits may be conducted if deemed necessary for the purpose of subject safety.
Demography, Baseline Characteristics, and Medical History
Demographic and baseline characteristics of the subject will be collected at the Screening Visit and updated at the Baseline Visit.
Baseline data will include date of birth, date of FVIII inhibitor diagnosis, FVIII genotype information, FVIII treatment at the time of inhibitor diagnosis, FVIII products used prior to ITI start, bleeding events prior to ITI start (collected from medical records for a period of up to 12 months prior to Screening), peak FVIII inhibitor titer before start of Alphanate ITI (from medical records) and the date of this assessment, and FVIII inhibitor titer at the last measurement prior to start of Alphanate ITI.
For subjects who do not have a documented **Factor VIII genotype**, a blood sample should be obtained at the Baseline Visit (or at a later clinic visit if blood volumes at the Baseline Visit are restrictive) and sent to the central laboratory for genotyping analysis.
Medical history will be collected at Screening to determine the subject’s eligibility.