Table 4.

Summary of adverse events experienced in the study.

n [%]	Treatment-emergent period [N = 85]	Follow-up period [N = 72]
Patients with ≥ 1 AE	61 [71.8]	8 [11.1]
Patients with ≥ 1 SAE	6 [7.1]	0 [0]
Patients with ≥ 1 possibly treatment-related AE	27 [31.8]	0 [0]
Patients with ≥ 1 treatment-related SAE	0 [0]	0 [0]
Patients with ≥ 1 treatment-related AE leading to discontinuation of study treatment	16 [18.8]	0 [0]
Deaths	0 [0]	0 [0]

AE, adverse event; SAE, serious adverse event.