Table 3 Patients with adverse events (AEs).

Event, n (%)	All patients (n = 3144)	8-week (n = 2601)	12-week (n = 522)	16-week (n = 21)
Any adverse event	864 (27.5)	636 (24.5)	225 (43.1)	3 (14.3)
Serious adverse event	8 (0.3)	6 (0.2)^a	2 (0.4)^b	0 (0.0)
Adverse event occurring in ≥ 1% of total patients
Fatigue	237 (7.5)	181 (7.0)	56 (10.7)	0 (0.0)
Pruritus	210 (6.7)	156 (6.0)	53 (10.2)	1 (4.6)
Dizziness	48 (1.5)	38 (1.5)	10 (1.9)	0 (0.0)
Total blood bilirubin increased¹
Grade 1	15 (0.5)	9 (0.4)	6 (1.2)	0 (0.0)
Grade 2	74 (2.4)	58 (2.2)	16 (3.1)	0 (0.0)
Grade3	9 (0.3)	5 (0.2)	4 (0.8)	0 (0.0)
Alanine aminotransferase increased²
Grade 1	23 (0.7)	16 (0.6)	7 (1.3)	0 (0.0)
Grade 2	26 (0.8)	19 (0.7)	7 (1.3)	0 (0.0)
Grade 3–4	20 (0.6)	15 (0.6)	5 (0.9)	0 (0.0)
Aspartate aminotransferase increased²
Grade 1	31 (1.0)	26 (1.0)	4 (0.8)	1 (4.8)
Grade 2	9 (0.3)	6 (0.2)	3 (0.6)	0 (0.0)
Grade 3–4	21 (0.7)	16 (0.6)	5 (1.0)	0 (0.0)

^a1 patient Rt eye ptosis; 1 patient Arrhythmia; 1 patient Upper gastrointesinal tract bleeding, acute on Chronic kidney disease;1 patient Liver nodule;1 patient Hepatocellular carcinoma;1patient dizziness.
^b1 patient Hepatocellular carcinoma recurrent; 1 patient Colon cancer.
Adverse Events graded based on CTCAE 5.0.
¹Total Blood bilirubin increased: Grade1: 1.0 ULN -1.5 × ULN if baseline was normal; > 1.0 to 1.5 × baseline if baseline was abnormal; Grade2: > 1.5 to 3.0 × ULN if baseline was normal; > 1.5 to 3.0 × baseline if baseline was abnormal; Grade3: > 3.0 − 10.0 × ULN if baseline was normal; > 3.0 − 10.0 × baseline if baseline was abnormal.
²Alanine aminotransferase/ Aspartate aminotransferase increased: Grade1: > 1.0 to 3.0 × ULN if baseline was normal; > 1.5 to 3.0 × baseline if baseline was abnormal; Grade2: > 3.0 − 5.0 × ULN if baseline was normal; > 3.0–5.0 × baseline if baseline was abnormalGrade3: > 5.0 − 20.0 × ULN if baseline was normal; > 5.0 − 20.0 × baseline if baseline was abnormal; Grade4: > 20.0 × ULN if baseline was normal; > 20.0 × baseline if baseline was abnormal.

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