Table 3 Occurrence status of ADRs of safety specification by grade.

Safety specification system organ class; preferred term	Safety analysis set (N = 76)
Safety specification system organ class; preferred term	All grades	Grade ≥ 3	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5
Total, n (%)	42 (55.26)	13 (17.11)	22 (28.95)	19 (25.00)	13 (17.11)	0	0
Eye disorders, n (%)	1 (1.32)	0	0	1 (1.32)	0	0	0
Retinal detachment	1 (1.32)	0	0	1 (1.32)	0	0	0
Pyrexia, n (%)	35 (46.05)	3 (3.95)	16 (21.05)	16 (21.05)	3 (3.95)	0	0
Pyrexia	35 (46.05)	3 (3.95)	16 (21.05)	16 (21.05)	3 (3.95)	0	0
Hepatic impairment, n (%)	8 (10.53)	6 (7.89)	2 (2.63)	1 (1.32)	6 (7.89)	0	0
AST increased	4 (5.26)	3 (3.95)	0	1 (1.32)	3 (3.95)	0	0
ALT increased	4 (5.26)	2 (2.63)	1 (1.32)	1 (1.32)	2 (2.63)	0	0
Abnormal hepatic function	3 (3.95)	2 (2.63)	1 (1.32)	0	2 (2.63)	0	0
Gamma-glutamyl transferase increased	1 (1.32)	1 (1.32)	0	0	1 (1.32)	0	0
Liver disorder	1 (1.32)	1 (1.32)	0	0	1 (1.32)	0	0
Cardiac disorder, n (%)	8 (10.53)	1 (1.32)	4 (5.26)	3 (3.95)	1 (1.32)	0	0
Hemoptysis	1 (1.32)	1 (1.32)	0	0	1 (1.32)	0	0
Atrioventricular block first degree	1 (1.32)	0	1 (1.32)	0	0	0	0
Edema peripheral	2 (2.63)	0	2 (2.63)	0	0	0	0
Localized edema	1 (1.32)	0	1 (1.32)	0	0	0	0
Left ventricular dysfunction	1 (1.32)	0	0	1 (1.32)	0	0	0
Ejection fraction decreased	2 (2.63)	0	1 (1.32)	1 (1.32)	0	0	0
Cardiac disorders	1 (1.32)	0	0	1 (1.32)	0	0	0
Rhabdomyolysis, n (%)	9 (11.84)	6 (7.89)	3 (3.95)	1 (1.32)	6 (7.89)	0	0
Rhabdomyolysis	5 (6.58)	4 (5.26)	0	1 (1.32)	4 (5.26)	0	0
Blood CPK increased	5 (6.58)	2 (2.63)	3 (3.95)	0	2 (2.63)	0	0

ADR adverse drug reaction, ALT alanine aminotransferase, AST aspartate aminotransferase, CPK creatine phosphokinase, MedDRA medical dictionary for regulatory activities.
For system organ class, multiple preferred terms occurring in the same patient are counted as 1 patient for each preferred term, but overlapping patients are counted as 1 patient for standard organ class.
For preferred term, if the same event occurs more than once in the same patient, then the patient is counted as 1 patient.
Preferred term is shown in the order of descending incidence in the grade ≥ 3 column.
ADRs were coded using MedDRA/J version 26.0.

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