Includes treatment-related AEs occurring in ≥2 patients, AEs due to any cause occurring in ≥5% patients, and AEs of special interest. Relatedness of the AE was determined by the investigators. Multiple AEs may have occurred in a single patient.

The exposure-adjusted (EA) rate is defined as the number of patients with at least 1 AE per 100 patient-years.

In patients on rilzabrutinib who had an AE of grade ≥3 that was due to any cause and occurred in a single patient each, these AEs were asthenia, epistaxis, esophageal varices hemorrhage, facial paralysis, hepatic cirrhosis, hepatic enzyme increased, hyperglycemia, ITP, intermenstrual bleeding, otitis media acute, pelvic inflammatory disease, periorbital hematoma, platelet count decreased, pneumonia, renal abscess, sepsis, swelling of eyelid, thrombocytopenia, urinary tract infection, and vaginal hemorrhage.

In patients on placebo who had an AE of grade ≥3 that was due to any cause and occurred in a single patient each, these AE swere conjunctival hemorrhage, heavy menstrual bleeding, hematemesis, hypertension, ITP, mouth hemorrhage, and syncope.

Grade 3 purpura was the only treatment-related bleeding event in the placebo arm; there were no grade ≥2 bleeding-related AEs in the rilzabrutinib arm.

Grade 2 upper respiratory tract infection in 2 patients and grade 2 chronic sinusitis in 1 patient were the only rilzabrutinib-related infectious events; there were no grade ≥2 infectious events in the placebo arm.