Safety assessments
myalgia, Local cutaneous reaction, pain, pyrexia, pruritus, chills, arthralgia
EVENT, INJECTION SITE SWELLING, ADVERSE EVENT, INFLUENZA-LIKE ILLNESS, BLOOD, INJECTION SITE ERYTHEMA
Blood samples were collected before dosing for all standard laboratory tests. Urine protein was determined using dipstick. Data were imported from individual study data sets into one SAS dataset for each laboratory test [Flu-like reactions (FLRs) were defined as either (a) influenza-like illness or (b) pyrexia or feeling hot or body temperature increased, plus at least two of the following: chills, myalgia, and arthralgia, started on the day of injection or the next day. Local cutaneous reaction at the injection site (LCRIS) was defined as injection site erythema, injection site swelling, injection site pruritus, or injection site pain that started on the day of injection and persisted (start to stop) for 2 days or more.An alternate calculation, LCRISv2, was defined as moderate or severe injection site erythema, injection site swelling, injection site pruritus, or injection site pain that started on the day of injection and persisted for at least 2 days; or any adverse event (AE) at the injection site, regardless of severity, which leads to discontinuation of study drug, where AE at the injection site is the principal reason for treatment discontinuation. The percentage of injections leading to a tolerability event (FLR, LCRIS, or LCRISv2) was calculated for each subject as follows: (number of injections with event/total number of injections) × 100.