TABLE 4

Overview of TEAEs in the ITT population

VariableNo. (%) of patients (total n = 103)
Patients with at least 1 TEAE69 (67.0)
Patients with at least 1 drug-related TEAE52 (50.5)
Patients with TEAEs by maximum severity
    Mild36 (35.0)
    Moderate28 (27.2)
    Severe5 (4.9)
Patients with drug-related TEAEs by maximum severity
    Mild31 (30.1)
    Moderate17 (16.5)
    Severe4 (3.9)
Deaths0 (0.0)
Patients with at least 1 treatment-emergent SAE4 (3.9)
Patients with at least 1 drug-related treatment-emergent SAE0 (0.0)
Patients who discontinued due to a TEAE4 (3.9)a
Patients who discontinued due to a drug-related TEAE2 (1.9)
  • a In the analysis of patient disposition, 1 of these 4 patients was considered a per-protocol completer due to the number of doses completed.