The principal stop point was the protection and tolerability of sifalimumab. Remedy-emergent adverse events (AEs) and major AEs (SAEs) and their severity, result, and any connection to the examine medication were being recorded with the investigator throughout the review. AEs were deemed very likely to be linked to analyze medication should they ha

In addition, sufferers were being questioned to produce an crisis visit when they made signs and symptoms according to deep vein thrombosis, pulmonary embolism, or bleeding. At Each and every regime go to, the affected individual was questioned about signs of recurrent venous thromboembolism, and correct diagnostic tests was performed if there was