Table 3 Comparison of the main treatment-emergent adverse events in the safety set

No.

423

425

848

Overall n (%)

30 (7.1)

33 (7.8)

63 (7.4)

Laboratory tests, n (%)

14 (3.3)

17 (4.0)

31 (3.7)

Psychiatric disorders, n (%)

3 (0.7)

5 (1.2)

8 (9.4)

Cutaneous or subcutaneous disorders, n (%)

4 (0.9)

1 (0.2)

5 (5.9)

Neurological diseases, n (%)

2 (0.5)

2 (0.5)

4 (4.7)

Gastrointestinal disorders, n (%)

3 (0.7)

1 (0.2)

4 (4.7)

Vascular or lymph disorders, n (%)

2 (0.5)

2 (0.5)

4 (4.7)

Cardiac disorders, n (%)

1 (0.2)

2 (0.5)

3 (3.5)

Metabolic and nutritional disorders, n (%)

2 (0.5)

0 (0)

2 (2.4)

Nasal disorders, n (%)

2 (0.5)

0 (0)

2 (2.4)

Infectious disorders, n (%)

1 (0.2)

1 (0.2)

2 (2.4)

Respiratory disorders, n (%)

0 (0)

1 (0.2)

1 (1.2)

Musculoskeletal and connective tissue disorder, n (%)

0 (0)

1 (0.2)

1 (1.2)

Immune disorders, n (%)

0 (0)

1 (0.2)

1 (1.2)

TEAE, n (%)

30 (7.1)

33 (7.8)

63 (7.4)

ADR, n (%)

3 (0.7)

4 (0.9)

7 (0.8)

SAE, n (%)

0 (0)

0 (0)

0 (0)

SADR

0 (0)

0 (0)

0 (0)

TEAE leading to study drug discontinuation

0 (0)

2 (0.5)

2 (0.2)

ADR leading to study drug discontinuation

0 (0)

0 (0)

0 (0)