Table 3.

Adverse events.

System Organ Class Preferred Term	HU-014 (n = 13)
Ear and labyrinth disorders
Vertigo positional a	1(7.69) [2]
Metabolism and nutrition disorders
Diabetes mellitus b	1(7.69) [1]
Hyperglycemia b	1(7.69) [1]
Blood and lymphatic system disorders
Iron deficiency anemia c	1(7.69) [1]
Gastrointestinal disorders
Periodontal disease c	1(7.69) [1]
Psychiatric disorders
Insomnia a	1(7.69) [1]

Data are number of patients (%) (number of cases); ^a,b,c The same patient presented a, b, and c. Adverse events occurred in 3 (23.08%, 7 cases) out of 13 patients.