Table 2.

Overview of Treatment-Emergent Adverse Events (Safety Population).

	Cohort 1: 5.78 g N = 10		Cohort 2: 1.93 g N = 5		Cohort 3: 0.58 g N = 4		Pooled Placebo N = 19
	Events	Patients (%)	Events	Patients (%)	Events	Patients (%)	Events	Patients (%)
Total Number of TEAEs	10	7 (70.0)	4	3 (60.0)	0	0	7	7 (36.8)
Total Number of SAEs	0	0	0	0	0	0	0	0
Total Number of Treatment-related SAEs	0	0	0	0	0	0	0	0
TEAEs Leading to Discontinuation	0	0	0	0	0	0	0	0
Severity1
Mild	7	4 (40.0)	4	3 (60.0)	0	0	7	7 (36.8)
Moderate	3	3 (30.0)	0	0	0	0	0	0
Severe	0	0	0	0	0	0	0	0
Relationship to Study Treatment
Unrelated	4	3 (30.0)	4	3 (60.0)	0	0	5	5 (26.3)
Related2	6	4 (40.0)	0	0	0	0	2	2 (10.5)

A treatment-emergent adverse event (TEAE) was defined as an adverse event that started on or after the start of the administration of study treatment. If adverse event dates and times were incomplete and it was unclear whether the adverse event was treatment-emergent, it was assumed to be treatment-emergent and assigned to both periods.

N = the number of participants in the analysis set receiving the treatment. (%) = participants/N*100.

¹If a participant experienced more than one TEAE, the participant was counted once at the most severe or most related event.

²Related adverse events are those classified as possibly related, probably related, or definitely related. All related adverse events reported in the study were deemed “possibly” related.