Safety and Immunogenicity Outcomes
TEAEs, hemolytic
ADVERSE EVENT, EVENT, BLOOD
Secondary endpoints were the occurrence of TEAEs, clinical laboratory parameters, vital signs, and immunogenicity. TEAEs were defined as any event emerging at or after initiation of fSCIG 20% treatment or any existing event that worsened in intensity or frequency following fSCIG 20% exposure. TEAEs were defined as temporally associated with fSCIG 20% if they occurred within 72 h of completing fSCIG 20% infusion; the investigator determined whether TEAEs were local, systemic, or related to fSCIG 20%. The Common Terminology Criteria for Adverse Events (CTCAE; US Department of Health and Human Services, Washington, DC, USA) [Clinically significant treatment-emergent changes in clinical laboratory measures and vital signs were also recorded as TEAEs. Blood samples for hemolytic panel were collected at day −1 and on day 4; blood samples for hemoglobin were collected during screening and on day −1 and day 3. Blood samples for serum chemistry, hematology, and urine samples for urinalysis were collected during screening and on day −1 and day 30 (± 3 days). Vital signs were assessed during screening and on day −1, day 1, day 4, and day 30 (± 3 days), and at the end of the study; 12-lead ECG was also performed during screening and on day 1 within 1 h of fSCIG 20% dosing.Immunogenicity was determined by the occurrence of binding and neutralizing antibodies to rHuPH20. Blood samples for binding anti-rHuPH20 antibodies were collected on day −1 and day 30 (± 3 days) post-dose, and at the end of the study; post-dose samples with anti-rHuPH20 antibody titers ≥ 1:160 were analyzed for the presence of neutralizing antibodies.There were also subcutaneous administration endpoints that represented supportive tolerability and safety measures and consisted of the maximum tolerable infusion rate achieved, total volume infused, and infusion duration (all per infusion site).