Table 4.

Summary of Treatment-Emergent Adverse Events

TEAE (Safety Analysis Set)	Current Formulation in 52 Patients (3-Hour IV) N (%)	New Formulation in 50 Patients (1-Hour IV) N (%)
Patients with at least 1 TEAE	31 (59.6)	24 (48.0)
Patients with a study drug-related TEAE	20 (38.5)	11 (22.0)
Patients with a severe or higher TEAE	3 (5.8)	1 (2.0)
Patients with a serious TEAE	1 (1.9)	2 (4.0)
Patients with a study drug-related serious TEAE	0 (0.0)	0 (0.0)
Patients with a TEAE leading to study drug discontinuation	1 (1.9)	0 (0.0)
Patients with a TEAE leading to study drug interruption	3 (5.8)	2 (4.0)
Patients with a TEAE of special interest (AESI)	2 (3.8)	2 (4.0)

Abbreviations: AESI, adverse events of special interest; IV, intravenous; TEAE, treatment-emergent adverse event.