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. 2021 Feb 28;33(1):103–114. doi: 10.21147/j.issn.1000-9604.2021.01.11

2. Safety evaluation.

Variables n (%)
Escalation cohort (N=19) Expansion cohort (N=25)
Any grade Grade 3/4 Any grade Grade 3/4
*, ADRs occurring in 20% or more of patients in either cohort are shown. AE, adverse event; ADR, adverse drug reaction; GGT, glutamyl transpeptidase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; AST, aspartate aminotransferase.
Serious AEs 1 (5.3) 1 (5.3) 4 (16.0) 4 (16.0)
Serious ADRs 1 (5.3) 1 (5.3) 1 (4.0) 1 (4.0)
Any AEs 19 (100) 7 (36.8) 25 (100) 14 (56.0)
Any ADRs 19 (100) 5 (26.3) 25 (100) 12 (48.0)
AEs requiring medical intervention 9 (47.4) 0 (0) 18 (72.0) 0 (0)
ADRs requiring medical intervention 7 (36.8) 0 (0) 18 (72.0) 0 (0)
AEs requiring dose interruption/reduction 3 (15.8) 0 (0) 4 (16.0) 0 (0)
ADRs requiring dose interruption/reduction 3 (15.8) 0 (0) 4 (16.0) 0 (0)
AEs leading to discontinuation 2 (10.5) 0 (0) 4 (16.0) 0 (0)
ADRs leading to discontinuation 1 (5.3) 0 (0) 1 (4.0) 0 (0)
Clinical ADRs*
　Hair color changes 15 (78.9) 0 (0) 17 (68.0) 0 (0)
　Fatigue 11 (57.9) 0 (0) 16 (64.0) 0 (0)
　Portal hypertension 10 (52.6) 0 (0) 13 (52.0) 0 (0)
　Diarrhea 9 (47.4) 0 (0) 8 (32.0) 0 (0)
　Oral mucositis 9 (47.4) 0 (0) 8 (32.0) 0 (0)
　Periorbital Edema 5 (26.3) 0 (0) 8 (32.0) 0 (0)
　Alopecia 5 (26.3) 0 (0) 7 (28.0) 0 (0)
　Skin disorders 4 (21.1) 0 (0) 0 (0) 0 (0)
　Skin hypopigmentation 4 (21.1) 0 (0) 4 (16.0) 0 (0)
　Cough 3 (15.8) 0 (0) 6 (24.0) 0 (0)
　Anorexia 3 (15.8) 0 (0) 10 (40.0) 0 (0)
Laboratory ADRs*
　Hypertriglyceridemia 12 (63.2) 0 (0) 12 (48.0) 0 (0)
　Proteinuria 12 (63.2) 0 (0) 10 (40.0) 0 (0)
　White blood cell decreased 10 (52.6) 0 (0) 11 (44.0) 0 (0)
　Neutrophil Count Decreased 9 (47.4) 0 (0) 8 (32.0) 0 (0)
　Hypothyroidism 8 (42.1) 0 (0) 5 (20.0) 0 (0)
　Hypophosphatemia 5 (26.3) 0 (0) 4 (16.0) 0 (0)
　Anemia 5 (26.3) 0 (0) 9 (36.0) 0 (0)
　Blood creatinine increased 4 (21.1) 0 (0) 7 (28.0) 0 (0)
　Blood bilirubin increased 4 (21.1) 0 (0) 5 (20.0) 0 (0)
　GGT increased 4 (21.1) 0 (0) 8 (32.0) 0 (0)
　Blood unbound bilirubin increased 4 (21.1) 0 (0) 4 (16.0) 0 (0)
　ALT increased 4 (21.1) 0 (0) 12 (48.0) 0 (0)
　AST increased 2 (10.5) 0 (0) 9 (36.0) 0 (0)
　Cholesterol high 3 (15.8) 0 (0) 9 (36.0) 0 (0)
　Hypoproteinemia 0 (0) 0 (0) 7 (28.0) 0 (0)
　Hyponatremia 2 (10.5) 0 (0) 6 (24.0) 0 (0)
　ALP increased 1 (5.3) 0 (0) 5 (20.0) 0 (0)