CONSORT flow diagram. ∗After 12 weeks, responders with platelet count of ≥50 × 109/L or 30 × 109/L to <50 × 109/L and at least doubled from baseline (referred to as “platelet response”) could continue blinded treatment; nonresponders could discontinue or enter the 28-week open-label period receiving rilzabrutinib 400 mg twice daily (initial treatment remained blinded). Patients who discontinued the 24-week double-blind period because of lack of response were given the option to enter the 28-week open-label period. †Includes patients who have entered as of the data cutoff. All patients in the 28-week open-label and long-term extension periods received rilzabrutinib 400 mg twice daily despite their initial treatment arm assignment. ‡Included 1 patient who discontinued because of an AE of pneumonia that was deemed unrelated to treatment per investigator judgment and lasted 16 days before rilzabrutinib was discontinued and the patient died (see the supplemental Safety Results for details). bid, twice daily.
