. 2021 Jun 30;33(3):405–416. doi: 10.21147/j.issn.1000-9604.2021.03.11

Table S5. TEAEs following single and multiple administrations of HLX01 (phase 1a study).

TEAE^a	n (%)
TEAE^a	250 mg/m² (N=3)			375 mg/m² (N=6)			500 mg/m² (N=3)
TEAE, treatment-emergent adverse event; ADR, adverse drug reaction; SAE, serious adverse event; WBC, white blood cell; ALT, alanine aminotransferase; AST, aspartate aminotransferase; Ig, immunoglobulin; GGT, gamma-glutamyl transpeptidase; LDH, lactic acid dehydrogenase. ^a, Excluding infusion-related reactions; ^b, Where possible causal relationship to drug, device or administration; ^c, The patient has experienced upper respiratory tract infection twice; ^d, The patient has experienced sinus bradycardia for three times.
Single dose
Patients with ≥1 TEAE	2 (66.7)			0			0
Patients with ADR^b	1 (33.3)			0			0
Patients with significant TEAE	1 (33.3)			0			0
Patients with SAE	0			0			0
Patient death due to TEAE	0			0			0
Patient discontinuation due to TEAE	0			0			0
Grade of TEAE with single dose	Grade 1	Grade 2		Grade 1	Grade 2	Grade 3	Grade 1	Grade 3
Fever	1 (33.3)	0		0	0	0	0	0
Chills	1 (33.3)	0		0	0	0	0	0
Upper respiratory infection	0	1 (33.3)		0	0	0	0	0
Multiple doses
Patients with ≥1 TEAE	3 (100)			4 (66.7)			3 (100)
Patients with ADR^b	2 (66.7)			3 (50.0)			2 (66.7)
Patients with significant TEAE	1 (33.3)			1 (16.7)			0
Patients with SAE	0			0			1 (33.0)
Patient death due to TEAE	0			0			0
Patient discontinuation due to TEAE	0			0			0
Grade of TEAE with multiple doses	Grade 1	Grade 2	Grade 3	Grade 1	Grade 2	Grade 3	Grade 1	Grade 3
WBC decreased	2 (66.7)	0	0	0	2 (33.3)	0	0	0
ALT increased	1 (33.3)	0	0	0	0	1 (16.7)	0	0
AST increased	1 (33.3)	0	0	1 (16.7)	1 (16.7)	0	0	0
Blood calcium decreased	1 (33.3)	0	0	0	0	0	0	0
Chills	1 (33.3)	0	0	0	0	0	0	0
Fever	1 (33.3)	0	0	0	0	0	0	0
Protein albumin ratio decreased	1 (33.3)	0	0	0	0	0	0	0
IgG decreased	1 (33.3)	0	0	0	0	0	0	0
IgM decreased	1 (33.3)	0	0	0	0	0	0	0
Blood potassium decreased	1 (33.3)	0	0	1 (16.7)	0	0	0	0
Neutrophil count decreased	0	0	1 (33.3)	0	1 (16.7)	0	0	0
Palpitations	1 (33.3)	0	0	0	0	0	0	0
Upper respiratory tract infection	0	1 (33.3)^c	0	0	0	0	1 (33.3)	0
Sinus bradycardia	0	0	0	1 (16.7)^d	0	0	0	0
Dizziness	0	0	0	1 (16.7)	0	0	0	0
GGT increased	0	0	0	1 (16.7)	0	0	0	0
LDH increased	0	0	0	1 (16.7)	0	0	0	0
Platelets decreased	0	0	0	1 (16.7)	0	0	0	0
Blood uric acid increased	0	0	0	1 (16.7)	0	0	0	0
Ventricular arrhythmia	0	0	0	0	0	0	1 (33.3)	0
Elevated blood pressure	0	0	0	0	0	0	1 (33.3)	0
Herpes virus infection	0	0	0	0	1 (16.7)	0	0	0
Anal fistula	0	0	0	0	0	0	0	1 (33.3)