Table 3.

Serious adverse events^a

SOC and PTbb	N = 15b
	n (%)b
Number of patients with at least one SAE	4 (26.7)
Cardiac disorders
Ejection fraction decreased	1 (6.7)
Infections and infestations
Lung infection	1 (6.7)
Urinary tract infection	1 (6.7)
Sepsis	1 (6.7)
Musculoskeletal and connective tissue disorders
Pain	1 (6.7)
Nervous system disorders
Seizure	1 (6.7)

^aSAE: any AE resulting in death; immediately life threatening; requiring inpatient hospitalization or prolongation of hospitalization; resulting in persistent or substantial disability/incapacity; a congenital anomaly/birth defect in a child whose parent has been exposed to a medicinal product before conception or during pregnancy or is considered otherwise medically substantial, such as important medical events that may not immediately be life threatening or result in death or hospitalization, but jeopardize the subject or require intervention to prevent one of the outcomes listed in the definition above.

^bSOC, system organ class; PT, preferred term; N, number of patients in the safety analysis set; n, number of patients.