Figure 1.
Figure 1. Trial design, subject enrollment, and disposition. (A) Study design. (B) Subject enrollment. Prednisone taper (GC1 and GC2). The dose of prednisone (or equivalent) was adjusted at weekly clinic visits according to the blood AEC and clinical signs and symptoms. GC dose was tapered by 5 mg weekly until 15 mg daily and then by 2.5 mg weekly. The decision to decrease to the next lower dose was based on the AEC and presence or absence of HES symptoms. If the AEC rose to ≥1000/µL or HES symptoms were present, then prednisone (or equivalent) was increased to the previous dose. If a subject’s AEC continued to climb or symptoms persisted despite a dose increase, then the GC dose was increased further or the subject was withdrawn from the study at the investigator’s discretion.

Trial design, subject enrollment, and disposition. (A) Study design. (B) Subject enrollment. Prednisone taper (GC1 and GC2). The dose of prednisone (or equivalent) was adjusted at weekly clinic visits according to the blood AEC and clinical signs and symptoms. GC dose was tapered by 5 mg weekly until 15 mg daily and then by 2.5 mg weekly. The decision to decrease to the next lower dose was based on the AEC and presence or absence of HES symptoms. If the AEC rose to ≥1000/µL or HES symptoms were present, then prednisone (or equivalent) was increased to the previous dose. If a subject’s AEC continued to climb or symptoms persisted despite a dose increase, then the GC dose was increased further or the subject was withdrawn from the study at the investigator’s discretion.

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